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Career postings for the Massachusetts Biotechnology Council

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    Sr. Director, Clinical Operations

    Responsible for global clinical operations for all clinical trials from pre-clinical to Phase III, including the direction, planning, and execution of clinical trials, project planning, budget, resource management,  contract research organization and vendor management, data collection, analysis, and reporting to prepare documentation required for inclusion in the company’s regulatory submissions.

     

    Responsibilities include:

    Ensures compliance with good clinical practices and regulatory guidelines. 

    Develops high quality, integrated cross-functional plans for managing clinical research activities including activities to be performed in-house or through third-party relationships to complete clinical trials according to the strategic plan to support product approvals.

    Develops and implements innovative process ideas to impact clinical trials management and applies best practices in the development, initiation, planning, execution, control and closing of clinical studies. 

    Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. 

    Responsible for clinical budget and development of contingency plans for clinical trials, and for ensuring that clinical projects adhere to budget, scope and schedule requirements.

    Responsible for adherence to protocols by clinical sites and contract research organizations. 

    Ensures that compliant processes are in place for distribution of clinical inventory to investigational sites.

    Interacts with finance, research and development, marketing, manufacturing, regulatory and other relevant departments as appropriate within the company and externally with investigational sites, clinical consultants, contract research organizations and other vendors. 

    Manages and coordinates clinical budget and related pricing strategy services for the purpose of executing clinical trials or ancillary services agreements.

    Ensures coordination of the activities of functional groups that comprise the clinical department team for the product including, but not limited to: clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to ensure proper conduct and timely completion of all clinical studies. 

    Selects, develops and evaluates personnel to ensure the efficient operation of the function.

    Oversees and develops the strategic planning and direction of patient recruitment efforts and feasibility of clinical studies in one or more therapeutic areas.

    Manages feasibility protocol assessments, site identification, study projection scenarios and vendor evaluation. 

    Identifies potential recruitment barriers, regional recruitment boundaries, contingency plans and implementation plans by country and site. 

    Education and Experience Requirements:

    BS, BSc, MS, MSc in science or healthcare preferred or equivalent relevant experience.

    At least 10 years in Clinical Operations within the biotech or pharma industry, with at least 5 years in oncology.

    Management of Phase 1 through Phase 3 clinical trials with complex sample collection, including tissue biopsies and blood samples for cytokines, pharmacokinetics, pharmacodynamics markers, and RNA analysis.

    Demonstrated excellence in selection and management of CROs and other study related vendors.

    Demonstrated ability to hire, lead and inspire teams of clinical operations professionals and to collaborate with interdisciplinary teams to accomplish clinical and corporate goals.

     

    Other Requirements:

    Enthusiastic, passionate about bringing important new therapies to patients with cancer, and willing to roll up his or her sleeves to do whatever it takes while building the right team of outstanding clinical operations professionals.

    Team player with outstanding communication skills.

     

    Preferred Experience:

    Immuno-oncology

    Companion diagnostics

     

    To be considered for this role, please submit your resume to Careers@JounceTx.com with the job title in the subject line of your email.

     

    We are an equal opportunity employer offering a competitive salary and benefits package.

     

    All applicants should be legally entitled to work for any employer in the US.

     

    Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.


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  • 11/19/15--00:49: Associate Scientist
  • Associate Scientist

    This is an opportunity for an ADME scientist with 1-3 years of experience in the pharmaceutical/CRO industry to assist in conducting and designing ADME assays at a fast-paced international company, the world leader in ADMET innovation.

    Cyprotex US, LLC is seeking a hands-on, highly motivated scientist to apply fundamental cell biology, biochemistry, and analytical techniques to conduct routine ADME assays. The successful candidate will actively participate in experimental design, performing experiments, and troubleshooting, as well as performing data analysis. The ideal candidate will be independent, self-motivated, collaborative, organized, and able to multitask effectively.  You will work in a collaborative, international team environment with other colleagues at Cyprotex US, LLC (US) and Cyprotex (UK).

    Requirements

    ▪   Experience working in drug discovery programs in pharmaceutical companies or CROs

    ▪   Have performed routine in vitro ADME assays and/or bioanalysis.

    ▪   Ability to work in a collaborative or independent manner in a fast paced environment.

     

    Basic Qualifications

    ▪   Results-oriented BS/MS.-level scientist with a hands-on experience in designing/conducting ADME/DMPK assays

    ▪   A minimum of 1 year of pharmaceutical/CRO industry experience

    Preferred Qualifications

    ▪   Working experience in testing compounds in cell based or biochemical assays

    ▪   Experience in handling LC/MS/MS instrumentation

    ▪    Experience with laboratory automation equipment is a plus

     

    Principals only. Relocation assistance not provided.

    To apply, email your résumé to US-careers@cyprotex.com


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    GENERAL SUMMARY OF POSITION:

    The Watts lab is seeking a research associate who will take responsibility for the group’s tissue culture facility, while helping with other research as needed. This work will involve transfecting oligonucleotides into cells, harvesting RNA and proteins and analyzing gene expression at the RNA and protein level. Some knowledge of chemistry is an asset, as our group focuses on the synthesis and biological testing of chemically modified oligonucleotides. We have recently moved to UMassMed from England, and this person will lead on setting up our tissue culture facility here.

     

    Applicants should describe their experience in all of these areas when applying: (all are “desirable” except the first is essential)

    -tissue culture (essential)

    -oligonucleotide synthesis

    -gene silencing

    -quantitative RT-PCR

    -western blotting

    -microbiology

    -setting up lab facilities / lab management

     

     

     

    MAJOR RESPONSIBILITIES:

    • Conducts in-depth analysis of research experiments
    • Performs complex laboratory experiments
    • Interprets data, forms conclusion, and decides on and plans next experiments to be done with a high degree of independence
    • Compiles and analyzes data and performs computations using image analysis software, spreadsheets, graphing, and curve fitting software
    • May modify protocols and be responsible for a single, independent research project
    • Assists in writing the text of scientific publications and grants. Reviews literature
    • Trains new laboratory personnel, students, and collaborators
    • Maintains laboratory supplies and equipment
    • Complies with all safety and infection control standards
    • Perform other duties as required



    REQUIRED QUALIFICATIONS:

    • Bachelor’s degree in Biological Sciences, or equivalent experience
    • 1 year relevant research experience
    • Knowledge of Microsoft Office products
    • Strong ability to analyze complex visual data in a quantitative and objective manner
    • Judgment and action skills required to solve commonly encountered problems

     

    PREFERRED QUAKIFICATIONS:

    • Experience with the following skills preferred:
    • oligonucleotide synthesis
    • gene silencing
    • quantitative RT-PCR
    • western blotting
    • microbiology
    • setting up lab facilities / lab management

     

     

     

     

     

    SUPERVISION RECEIVED:

    Under the direction of the Principal Investigator, or designee

     

    SUPERVISION EXERCISED:

    May functionally supervise Lab Technicians and Aides

     

    ENVIRONMENTAL WORKING CONDITIONS:

    Wet chemistry laboratory, and may require appropriate contact with biohazards, radionuclides, toxins, animals, and human specimens.



    Apply Here

    PI92352270


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    Job ID: 25565
    Date Posted: 01/21/2015
    Location: Yawkey Center for Cancer Care
    Job Family: Clinic Admin Sup Specialist
    Full/Part Time: Full-Time
    Regular/Temporary: Regular
    About Dana-Farber

    Located in Boston, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.


    Overview

    The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases.

    Our Core Values are:

    Impact - Above all else, we make a difference by relieving the burden of disease now and for the future through our research, clinical care, education, outreach and advocacy.

    Excellence - We pursue excellence relentlessly and with integrity in all that we do, adhering always to the highest standards of conduct.

    Compassion and Respect - For those in our care and for one another.

    Discovery - We foster the spirit of inquiry, promoting collaboration and innovation across traditional boundaries while celebrating individual creativity.

    GENERAL SUMMARY:

    Dana-Farber Cancer Institute is seeking Clinical Administrative Support Specialists (CASS) and New Patient Coordinators (NPC). These positions provide superior customer service to patients, family members, physicians and staff in functions related to initial patient contact, medical record retrieval and scheduling ongoing care. CASS/NPC are assigned to work on a clinical floor with face to face patient contact, or in a disease center where patient contact is mostly on the phone or via email. Both assignments work with physicians, physician’s assistants, technical staff, program nurses, nurse practitioners and other care providers to schedule patient appointments and transmit patient information. CASS/NPC will play a critical role in facilitating many aspects of patient care.

    Dana-Farber is seeking detail-oriented, compassionate and organized individuals to perform these essential functions. CASS/NPC role is an exciting opportunity to get front-line experience working with patients, providers and hospital administrators. This position provides an opportunity for someone looking to explore a profession in medicine, public health administration or clinical/ medical research. The fast-paced work environment is both challenging and highly rewarding.

    PRIMARY DUTIES AND RESPONSIBILITIES:

    Under the direction of Practice Managers or Managers of Disease Center Operations, the CASS/NPC schedules patient appointments ranging in complexity from one care provider to multiple care providers as well as ancillary appointments. CASS/NPC may also provide additional duties (examples listed below).

    • Serves as a liaison between patient/referring provider/ patient representative and the DFCI care team to procure detailed clinical information face-to-face, by telephone or electronically. This role performs independent patient and outside provider call triaging and assists in directing patient flow. Provide basic insurance referral and general disease or program-specific information to callers/patients.
    • May perform front desk check-in and check-out functions. CASS/NPC work closely with coordinators of in-house studies, and industry-sponsored clinical trials. This role may also prepare complex documents; process disability forms and prescription plan refills.
    • May provide general administrative support and coordination for all aspects of patient care for both new and/or established patients, including filing, document preparation, CD uploading, data entry, telephone support, etc. CASS/NPC may also be responsible for other administrative functions as needed by clinical and research staff including travel arrangements, conference material preparation and general schedule management. This role may teach or participate in training of other CASS/NPC hires.
    • The CASS/NPC is able to prioritize tasks and respond to urgent situations using SOP and critical thinking skills. A person in this role has the ability to remain calm and professional in a fast-paced and demanding work environment. Requires clinical, operational and regulatory knowledge of the standard of care or clinical trial protocol for the related patient population.

    MINIMUM JOB QUALIFICATIONS:

    Bachelor’s degree required. Must have a strong interest in providing customer service in a medical setting.

    KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

    Ability to multi-task and function as an integral member of the team. Excellent verbal and written communication skills required. Computer proficiency in a Windows environment required. Demonstrated ability to draft complex reports, correspondence and other administrative documents pertaining to patient scheduling as needed. Demonstrated ability to carry out complex scheduling as required. Excellent customer service and problem solving skills required.

    PATIENT CONTACT:

    Yes, this position entails patient contact and communication. Methods of contact are in person, via telephone, written letter or email. Age population served will depend upon clinical area assigned, (i.e. Pediatric or Adult clinic). This position may or may not include provision of wheelchair escort services.

    WORKING CONDITIONS:

    Ability to operate a computer, keyboard and standard office equipment required. While performing the duties of this job, the employee is occasionally required to stand; sit; walk; use hands to handle objects and office supplies; reach with hands and arms.



    Schedule

    40 hours per week



    How to Apply

    Please apply directly online at http://www.dana-farber.org/Careers/Careers-at-Dana-Farber.aspx. Click Search Job Openings and use the Job ID number to quickly locate the appropriate job listing. Once you have located the desired job, click on the checkbox in the 'Select' column, and then click the 'Apply Now' button, located at the bottom of the screen.

    DFCI Employees please apply directly through PeopleSoft Self Service. Sign on to PeopleSoft and navigate to Main Menu > DFCI Careers.



    Equal Employment Opportunity

    Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.




    Apply Here

    PI92360006


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    General Scope and Summary

    Oversee clinical development programs (pre-IND through Phase 1-3 clinical trials) in the field of neurology and CNS disorders. This key role will manage, plan, and execute clinical studies, including creating and managing study timelines, budgets, and study management plans. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s).  This position will report to the Director of Clinical Operations and Development.

     Roles and Responsibilities

    • Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
    • Create, manage, and execute clinical operations programs, including study management, and budget and Gantt timeline creation
    • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
    • Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
    • Co-monitor or monitor studies if needed for the program
    • Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
    • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
    • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
    • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed

     Experience, Education and Specialized Knowledge and Skills

    • Master’s degree preferred in a scientific or healthcare discipline
    • Minimum of 5+ years in clinical and drug development in the pharmaceutical/biotech industry
    • Understanding of drug development from pre-IND through NDA
    • Extensive experience managing clinical programs, CROs, budgets, and timelines required
    • Strong working knowledge of MS Project and developing Gantt charts
    • Excellent oral, written, and medical communication skills required
    • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
    • Management of CROs, multiple vendors, and complex protocols
    • Protocol, ICF, and CSR writing experience required
    • A detailed understanding of overall strategic direction, interrelationships and business needs
    • Experience is CNS/Neurology preferred and experience with orphan indications will be favorably considered
    • Proven experience in the oversight of the operational aspects of all stages of clinical studies
    • Ability to organize and manage multiple priorities required

     Attributes

    • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
    • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
    • Proactive and positive management approach
    • Maximum flexibility to adapt to changing program needs in real time
    • Strong leadership skills
    • Ability to build strong relationships with co-workers of various backgrounds and expertise
    • Excitement about the vision and mission of Sage 

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    General Scope and Summary

    The Director, Clinical Operations and Development will oversee clinical development of our lead program entering a Phase 3 trial in the field of neurology and CNS disorders. This key role will manage, plan, and execute clinical development programs and studies, including creating and managing study timelines, budgets, and study management plans. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s).  This position will report to the Head of Clinical Operations and Development.

    Roles and Responsibilities

    • Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
    • Create, manage, and execute clinical operations and development programs, including study management, budget and timeline creation
    • Manage and lead a team of three clinical operations staff
    • Ability to build strong KOL and Principal Investigator relationships, with the ability to easily understand and explain complex scientific topics
    • Lead program development teams, and understand the intricacies among the different cross-functional groups
    • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
    • Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary
    • Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
    • Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed
    • Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
    • Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
    • Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
    • Attend scientific conferences as needed

    Experience, Education and Specialized Knowledge and Skills

    • Master’s degree preferred in a scientific or healthcare discipline
    • Minimum of 10 years in clinical and drug development in the pharmaceutical/biotech industry (5+ years of managing people and leading a team)
    • Understanding of drug development and program management from pre-IND through NDA is essential.  Must have been through a successful NDA/BLA previously.
    • Extensive experience managing clinical programs, CROs, budgets, and timelines required
    • Strong working knowledge of MS Project and developing Gantt charts
    • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
    • Management of CROs, multiple vendors, and complex protocols
    • Protocol, ICF, and CSR writing experience required
    • A detailed understanding of overall strategic direction, interrelationships and business needs
    • Experience is CNS/Neurology preferred and experience with orphan indications will be favorably considered
    • Proven experience in the oversight of the operational aspects of all stages of clinical studies
    • Ability to organize and manage multiple priorities required
    • Excellent oral, written, and medical communication skills required
    • Ability and willingness to travel up to 25% of the time, as needed
    • Excitement about the vision and mission of Sage
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.

    Attributes

    • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high-performing colleagues
    • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
    • Proactive and positive management approach
    • Maximum flexibility to adapt to changing program needs in real time
    • Strong leadership skills
    • Ability to build strong relationships with co-workers of various backgrounds and expertise

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    We are seeking a highly motivated and strategic Program Manager of Early Phase Development to support the advancement of our checkpoint antibody candidates to IND and early phase clinical trials.   We are looking for an industry-experienced PM with the ability to facilitate local and cross-functional activities, apply procedural solutions to operations, and execute on project related decisions. \\Roles & Responsibilities  1. Drive CPM development candidates from lead development candidates through IND enabling programs to early phase programs and identify optimal resource allocation of development project resources 2. Provide accurate, traceable, up-to-date and consistent data as basis decision-making and planning, and transparency on portfolio risks, inter-dependencies, inconsistencies and need for alignment 3. Consult on harmonization of data sources, standardization of study designs, development project management and financial reporting tools 4. Engage multi-disciplinary and cross-functional project teams to constantly improve the ability of the organization to deliver on development commitments 5. Manage key stakeholders to increase alignment to strategic priorities 6.Ensure consistent communication of portfolio decisions and compliance to them, and ensure transparency on technology and product road-maps and their alignment with RPD strategy

    PhD Preferred

    3-5 years of professional experience, including project management, strategy development, budget development, and vendor management  • Advanced degree in life sciences (MSc/PhD preferred) or related technical discipline paired with a practical business background • Knowledge of antibody-drug development  • Solid organization and project management skills, ability to think strategically and systematically, analyze complex business issues and opportunities, and utilize sound judgment in deriving conclusions to establish the appropriate objectives and direction • Strong interpersonal skills to successfully perform in a complex global matrix environment, excellent stakeholder management skills, proven track record of consensus building and conflict management in challenging situations • Strong leadership skills in cross-functional teams with and without direct reporting lines; demonstrated ability to achieve results • Experience in multiple external partnerships in  early development and good understanding of research and laboratory operations  • Proven ability to manage multiple simultaneous projects  • Broad knowledge of research and biological testing, principles, concepts, methods, best practices  • Broad knowledge of pre-clinical in-vitro assays  • Extremely strong interpersonal skills, demonstrated ability to work in a highly collaborative environment and ability to achieve results through other managers and people  • Extremely strong written and oral communication and presentation skills


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    Primary Role
    This is an exciting, frontline, technical role in a rapidly growing pharmaceutical company, where we outsource 100% of all our manufacturing activities. This key role will support new product and technology introductions within the Global Supply Chain Organization of Technical Operations. Products to be supported are primarily sterile. These include sterile suspensions, solutions and/or lyophilized synthetic or biologically derived molecules formulated to be delivered by injection or for ophthalmic use.

    This position will be the primary technical point of contact for the Global Supply Chain organization with our internal, Pharmaceutical Sciences and external, Contract Manufacturing Organizations. The primary role of this individual will be to own, understand and continuously improve the process capability and supply chain resiliency for the products within their assigned product portfolio.

    Roles and responsibilities include, but are not limited to:
    * Technology selection and acquisition
    * Process design, development, optimization and verification
    * Technology transfer
    * New product introduction
    * Continuous improvement
    * Routine technical support

    This position reports to the Senior Director, Global Drug Product Manufacturing Science & Technology group. A Technical Ladder exists in the Global Pharmaceutical Technology and the Scientists / Engineers have an opportunity to progress their career as individual contributors up to the level of Senior Director / Technical Steward.

    Responsibilities

    40%
    Lead and /or support new product technology transfer to CMO sites, globally:
    * Define capabilities required at the CMO to successfully support new product introduction.
    * Assess gaps in capabilities and implement plan to build required capabilities at CMO to support technology transfer.
    * Assist the Global Pharmaceutical Sciences group with technology selection, process design, development and optimization
    * Design, develop and optimize product manufacturing processes using robust DoE and QbD principles.
    * Author, review and approval of relevant technical documentation, protocols, reports, and regulatory submissions, including but not limited to Basis of Design, Process Risk Assessment, Technology Transfer Plan, Validation Master Plan, etc.
    * Ensure that all technology transfers are right first time, and are implemented in a timely manner while meeting the requirements for quality, cost and customer service.

    40%
    Serve as in-house technical expert for assigned products, responsible for supporting all ongoing commercial programs and assuring a robust and resilient supply of products:
    * Develops, maintains and acts on comprehensive risk register for their product process.
    * Prioritize and drive investigation processes to closure, using standardized approaches, such as KT and A3, to timely closure such that supply is not negatively impacted. Ensure that timeline for tasks are met and facilitate corrective action to get the timeline back on track when adverse events cause a task to slip.
    * Facilitate communication between the departments, including meetings facilitation, progress tracking, and updates to supply chain leadership.
    * Manage and maintain change control throughout appropriate product groups.
    * Development & maintenance of technical product knowledge database and technical documents for assigned products. Dissect and interpret data from various sources, using that information to create scientific reports that when compiled represents a documented summary of known product knowledge.

    20%
    Continue to grow as a respected technical leader by;
    * Building and maintaining a network of robust relationships with Regulators, Suppliers, CMOs, OEMs and Key Opinion Leaders in their respective technical field.
    * Actively engaged in professional industry forums with an eye towards staying current.

    Education & Experience Requirements
    * Normally requires an advanced degree in a scientific/technical discipline with 8-12 years technical hands-on industry experience in development and/or manufacturing (both highly preferred) or a BS with 12-15 years. Applies expert knowledge of scientific/technical principles & concepts.
    * Minimum of 10 years technical hands on process engineering experience with one or more of the following: modified release oral solids, liquids, sterile parenteral and high potency formulations.
    * 5 years + direct experience in supporting manufacturing at CMOs
    * Previous experience of effectively managing global technical projects
    * Experience with large molecules drug product manufacturing a plus

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjg5ODMzLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Primary Role:
    As a key member of the Manufacturing Science & Technology group, this individual will be responsible for providing technical and scientific leadership to support upstream processes for commercial production and late stage clinical production of Biologics, including process and product investigations/troubleshooting, continuous process improvement and life-cycle management, technology transfer and process validation. This individual will lead or contribute as a key member of various cross- functional teams and will interact extensively with other departments within Shire, including MFG, PTS, QA, QC, PD, ENG and RA etc.

    The responsibilities will include:
    1. Provide significant support to CMC strategy development and provide efficient and effective technical support for internal and/or external manufacturing to enable robust supply of commercial products.
    2. Leading continuous process improvements, aimed at improving process robustness, capacity, and productivity, as per Shire's QbD paradigm.
    3. Work with cross functional partners to lead and/or support the evaluation and development of manufacturing technologies and implementation strategies. Data-driven decision analysis will be part of this person's role including but not limited to evaluation of internal vs external mfg., facility fit, cost of goods, conventional vs. single use technology.
    4. Leading and mentoring junior staff as an in-line and matrix group leader.

    Responsibilities:
    40%:
    Leading continuous process improvements, aimed at improving robustness, process ynderstanding, capacity, and productivity, as per Shire's QbD paradigm. Provide technical expertise and leadership in identifying opportunities, area for improvement, planning, designing and conducting experiments, analyzing data and documenting results towards continuous upstream process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance. Significant support for strategy development and efficient and effective technical support for internal and/or external manufacturing to enable robust supply.

    25%:
    Providing technical expertise and leadership in trouble-shooting and root cause analysis for process discrepancies and quality investigations of complex technical nature

    15%:
    Supporting regulatory inspections and filings as an author and reviewer.

    20%:
    Working with cross functional partners lead and/or support various data driven decision and options analysis including but not limited to internal vs external mfg., facility fit, cost of goods modeling, conventional vs single use technology

    Education & Experience Requirements:
    This individual will have a minimum of:
    * A PhD in Biochemistry/Protein Chemistry, Chemical Engineering or related disciplines with a minimum of 8 years of relevant experience in a biotechnology/pharmaceutical environment; or MS in Biochemistry/Protein Chemistry or Chemical Engineering or related discipline with a minimum of 10 years of experience; or BS in Biochemistry/Protein Chemistry or Chemical Engineering or related discipline with a minimum of 12 years of experience is required;
    * Proven record of technical leadership;
    * Proven ability to work in a fast paced environment with demonstrated capacity to balance multiple tasks and demands.
    Preferred
    * Hands-on experience in upstream process characterization leading to definition of design space;
    * Experience in development and implementation of process control strategy using QbD principles;
    * Experience with diverse upstream processes, equipment and unit operations such as cell expansion, production, bioreactor technology, perfusion, clarification, ultra-filtration, clarification etc.
    * Experience in implementation of disposables in manufacturing of biologics;
    * Experience with application of risk based approach in decision making related to development, characterization and manufacturing of Biologics.

    Application URL:http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjg3ODA0LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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  • 11/19/15--22:32: Associate Director
  • Primary Role:
    As a key member of the Manufacturing Science & Technology group, this individual will be responsible for providing technical and scientific leadership to support downstream/upstream/drug product processes for commercial production and late stage clinical production of Biologics, including process and product investigations/troubleshooting, continuous process improvement and life-cycle management, technology transfer and process validation. This individual will lead or contribute as a key member of various cross- functional teams and will interacts extensively with other departments within Shire, including Manufacturing, PTS, QA, QC, PD, Engineering and RA etc.

    The responsibilities will include:
    1. Provide significant support to CMC strategy development for efficient and effective technical support for internal and/or external manufacturing to enable robust supply.
    2. Leading continuous process improvements, aimed at improving robustness, capacity, and productivity, as per Shire's QbD paradigm.
    3. Implementation of effective and sustainable process control strategy including new Process and Analytical Technologies (PAT).
    4. Leading and mentoring junior staff as an in-line or matrix leader.

    Responsibilities:
    40%:
    Leading continuous process improvements, aimed at improving robustness, capacity, and productivity, as per Shire's QbD paradigm. Provide technical expertise and leadership in identifying opportunities/areas, planning, designing and conducting experiments, analyzing data and documenting results towards continuous downstream process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance. Significant support for strategy development for efficient and effective technical support for internal and/or external manufacturing to enable robust supply.

    25%:
    Provide technical expertise and leadership in trouble-shooting and root cause analysis for process discrepancies and quality investigations of complex technical nature

    20%:
    Implementation of effective and sustainable process control strategy including new Process and Analytical Technologies(PAT)

    15%:
    Supporting regulatory inspections and filings as an author and reviewer.

    Education & Experience Requirements:
    This individual will have a minimum of:
    * A PhD in Biochemistry/Protein Chemistry, Chemical Engineering or related disciplines with a minimum of 8 years of relevant experience in a biotechnology/pharmaceutical environment; or MS in Biochemistry or Chemical Engineering with a minimum of 10 years of experience is required;
    * Proven record of technical leadership;
    * Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands.
    Preferred
    * Hands-on experience in process characterization leading to definition of design space;
    * Experience in development and implementation of process control strategy using QbD principles;
    * Experience in implementation of disposables in manufacturing of biologics;
    * Experience with application of risk based approach in decision making related to development, characterization and manufacturing of Biologics.

    Key Skills, Abilities, and Competencies:
    * Have excellent knowledge and experience with biologics process development and GMP manufacturing support, including protein capture and recovery, chromatographic purification, filtration, and UF/DF etc.
    * Have experience in design-of-experiment (DoE) and the ability to analyze and interpret data collected.
    * Demonstrate teamwork/collaboration and the ability to communicate appropriately and effectively.
    * Be customer focused, results oriented, science driven and embrace Shire's values.
    * Have experience in GMP working environments.
    * This person will have technical leadership including the ability to influence, motivate, and drive technical rigor.
    * Candidate should have experience in healthcare/biotech/pharmaceutical industry with a demonstrated understanding of the interdependencies of research, technical development, cGMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, Regulatory and Product Strategy functions. Demonstrated leadership and capability for strategic analysis and issue resolution, organizational and project management skills working in a matrix environment is also required.
    * Should possess strong problem solving and risk based decision making skills and a strong ability to influence or manage without direct authority. Highly developed interpersonal skills will be a substantial component of being successful in this demanding role.

    Other Job Requirements:
    Minimal travel

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjQwMjQ1LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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  • 11/19/15--22:37: Sr. Upstream Engineer
  • Primary Role:
    As a key member of the Manufacturing Science & Technology group, this individual will be responsible for providing technical and scientific leadership to support downstream processes for commercial production and late stage clinical production of Biologics, including process and product investigations/troubleshooting, continuous process improvement and life-cycle initiatives, technology transfer and process validation. This individual will lead or contribute as a key member of various cross- functional teams and will interacts extensively with other departments within Shire, including Manufacturing, PTS, QA, QC, PD, Engineering and RA etc.

    The responsibilities will include:
    1) Leading and executing of continuous process improvements, and product life cycle initiatives aimed at improving robustness, capacity, and productivity, as per Shire's QbD paradigm.
    2) Lead/participate on cross-functional team for the implementation of continuous process improvements and life cycle initiatives
    3) Escalate obstacles encountered either during the design, execution or implementation of continuous process improvements and life cycle initiatives to manager for resolution.

    Responsibilities:
    60%:
    Lead and execute continuous process improvements, aimed at improving robustness, capacity, and productivity, as per Shire's QbD paradigm. Provide technical expertise and leadership in identifying opportunities/areas, planning, designing and conducting experiments, analyzing data and documenting results towards continuous upstream process improvement, including reducing recurring deviations, and increasing level of safety and/or compliance.

    25%:
    Lead/Participation on cross-functional teams for the identification and/or implementation of prioritized continuous process improvements and lifecycle initiatives, designed to improve process robustness, capacity and productivity.

    15%:
    Provide high quality of written study proposals, research and development reports, and investigation reports.

    Education & Experience Requirements:
    This individual will have a minimum of:
    * A PhD in Biochemistry/Protein Chemistry, Chemical Engineering or related disciplines with 0 to 4 years of relevant experience in a biotechnology/pharmaceutical environment; or MS in Biochemistry or Chemical Engineering or related disciplines with a minimum of 3 years of experience; or BS in Biochemistry or Chemical Engineering or related disciplines with a minimum of 5 years of experience is required.
    * Proven record of technical capabilities;
    * Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands.
    Preferred
    * Experience with both mammalian cell culture and microbial fermentation.
    * Hands-on experience in process development, process characterization and process optimization.
    * Experience with application of risk based approach in decision making related to development.

    Key Skills, Abilities, and Competencies:
    * Have excellent knowledge and experience with mammalian cell culture process development, scale up, tech transfer and GMP manufacturing support.
    * Experience in using design-of-experiment (DoE) and other experimental methodologies to support process improvements and life cycle initiatives.
    * Experience with analyzing and interpreting data and results; experience with statistical data analysis tools preferred.
    * Be customer focused, results oriented, science driven and embrace Shire's values.
    * Have the attitude to proactively learn new technologies and manage changes in purification process development and improvement.
    * Demonstrated ability to make risk based decisions.
    * Have experience in GMP working environments.
    * Have the ability to influence, motivate, and drive technical rigor when participating on cross-functional teams.

    Other Job Requirements:
    Domestic and international travel may be required for this position on a limited basis

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL: http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjA5NzE1LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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  • 11/19/15--22:47: VMO Contracts Lead
  • Primary Role:
    The Vendor Management Office (VMO) Contracts Lead will be responsible for a portfolio of IT contracts across both goods and services for a mix of providers. This role will partner with other members of the VMO, procurement, legal, HR, finance, and IT stakeholders to holistically manage the contracts for those providers. Shire IT will categorize vendors as strategic, niche, major or commodity. The VMO Contracts Lead will have responsibility for a set of contracts across the strategic, niche and major vendors.

    The VMO Contracts Lead is responsible for understanding Shire's overall goals and objectives, assisting in the prioritization of business technology sourcing solutions, ensuring that sourcing decisions support Shire goals, and that the sourcing approach provides maximum return on investment. Additionally, this role will participate in the IT organization's annual planning process, including budgeting, representing the demand for the assigned portfolio.

    Management of contracts includes, but is not limited to facilitation of the governance processes, reporting and reviews as defined within the contract; business case and ROI tracking; facilitation and execution of contract change requests; oversight of issues & risks tracking; Service Legal Agreement certification, audit, and management; contract deliverables and obligations management; coordination with the Service Management Office and the Program Management Office; invoice verification and payment management; service cost allocation management (e.g., chargebacks, allocation plan); financial performance reporting; expansion of scope to further rationalize IT's supplier landscape; determining appropriate/relevant access to provider knowledge and expert networks; etc. This role will also support the training of Service Managers, Tower Leads, Functional Leads, Service Provider Relationship Managers and other IT members with contract-related roles including appropriate f
    acilitation of updates to the providers' training (e.g., onboarding information, general Shire information, etc.).

    An example of one such contract is a 5-year, $100 million deal with a large tier-one outsourcing provider who will be providing Application Maintenance, Application Development and Managed Security Services to Shire.

    The Vendor Management Office has a strategy and roadmap with projects that mature the capability of the VMO, enable remediation efforts, etc. The VMO Contracts Lead will be responsible for managing a subset of these efforts and driving them to completion.

    Finally, the VMO Contracts Lead will contribute to the development of key performance indicators (operational and financial) and the business cases for improving effectiveness and efficiency of how Shire IT partners and engages with vendors. This role will also support VMO reporting, analytics and measurement against the key performance indicators.

    Responsibilities:
    60%: Contracts management:
    * Facilitation and execution of contract change requests utilizing a SharePoint tool - includes reviewing for quality and completeness, following-up for additional input, packaging request for signature and ensuring that the conforming process is working as expected
    * Oversight of issues & risks tracking
    * Service Legal Agreement certification, audit, and management - the management portion will be in coordination with the Service Management Organization
    * Contract deliverables and obligations management - understanding deadlines, milestones, deliverables and triggers within the contract and ensuring they are met/completed, will require hands on effort

    10%: Governance management:
    * Ensure that all of the defined meetings are happening with the appropriate documentation and attendees
    * Support escalations of issues from either party
    * Reviewing governance reports
    * Coordination with the Service Management Office and the Program Management Office
    * Expansion of scope to further rationalize IT's supplier landscape
    * Determining appropriate/relevant access to provider knowledge and expert networks and bringing that knowledge back to Shire in the appropriate forum
    * Training various constituents on the ins and outs of the contracts

    15%: Measurements and Reporting:
    * Understanding the original business case and ROI and creating periodic reports on delivery to the business case and ROI

    15%: Financial Management:
    * Invoice verification and payment management
    * Service cost allocation management (e.g., chargebacks, allocation plan)
    * Support the IT budgeting process along with renewals management process

    Education & Experience Requirements:
    * A Bachelor's Degree
    * 8+ years of Information Technology experience
    * 4+ years of project experience
    * 2+ years of consulting experience
    * Related work in the Pharmaceutical Industry desired
    * 2+ years of hands on experience managing IT contracts
    * 2+ years of hands on experience with SharePoint 2007 or later

    Other Job Requirements:
    * Domestic travel will be required, but estimating no more than 4-5 trips per year
    * International travel may be required, but on a very limited basis and estimated at no more than 1 time per year

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL: http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjI5NzkwLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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  • 11/19/15--22:53: Materials Planner
  • Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    The incumbent must be adept at maintaining the appropriate inventory levels to control inventory and carrying costs while ensuring a continuous supply of released materials to the production floor. In addition, this position is often required to perform “what-if” scenario analysis during periods of supply constraint, and must be able to identify risk mitigation/contingency plans that impact several cross-functional areas.

    Short range planning involves an approximate time fence of 6 – 9 months for MRP planned items. Longer term planning involves those items that have lead times, or supply situations, that require an inventory/procurement strategy in the 12 – 18 month horizon. The incumbent plans for the operations supported in buildings A and B as well as LDM and Cell Banking. Additionally Pilot support is provided as required.

    Responsibilities
    * This position is responsible for performing the associated materials planning functions in support of the commercial and clinical drug substance master production schedules at the Andover facility and 2nd and 3rd party manufacturing/packaging locations

    Responsibilities include: set-up, operation and maintenance of the MRP data in SAP, including recipes and bills-of-materials (BOMs), evaluate and re-prioritize raw material testing/release schedules to ensure continuous production operations.

    Qualifications
    * BA/BS degree in Business or related field with 3-5 years relevant experience with ERP systems or relevant business systems. APICS certification a plus.

    PHYSICAL/MENTAL REQUIREMENTS
    * No physical requirements necessary, this is primarily an office job.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
    * No non-standard work hours, it will be a normal day shift 8 hour day.

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL: http://www.aplitrak.com/?adid=SmltLlRhdm9saWVyaS41NzY2NS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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    Position Summary
    The incumbent will provide strong leadership and strategic direction to Moderna Therapeutics Quality Management System, consisting of the Quality Assurance, and Compliance and is responsible for ensuring the overall quality of our investigational drug Processes and drug candidates. This key individual will act as a subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, cGMP compliance, and in business matters involving pharmaceutical facility and laboratory operations. The incumbent will be tasked with strategic and operational responsibilities pertaining to Moderna's Global Quality System and an integral partner to Moderna's innovative technology platform.

    Responsibilities
    * Line leadership and cross functional leadership of quality focused teams across Moderna's broad ecosystem of functions.
    * Develop the processes and systems governed by cGXP regulations as well as compliance focused guidance documents and to monitor and control the quality of drug substances, drug products and medical devices.
    * Establish Quality Documentation Systems that define the GMP responsibilities of Moderna's contract manufacturing organizations (CMOs), contract laboratories (CLs), raw material/supply chain and component suppliers internally review test results, issue Certificates of Analysis(COAs).
    * Oversee and monitor Quality Assurance standards throughout the entire organization with particular focus on master production and control records in order to ensure that production and control operations are adequately defined and that good manufacturing practices are utilized for the manufacture of drug substances, drug products and devices.
    * Define and oversee standards for the testing of components, drug substance, drug product, in-process materials internally and at the CMOs and contract testing labs. Lead all quality investigations and manage the CAPA (Corrective and Preventative Action) function
    * Initiate and manage compliance standards and procedures throughout the entire organization.
    * Initiate and manage the Change Control and Document Control systems. Review and coordinate approval of all changes made to manufacturing and control processes including those that are initiated by partner Contract Manufacturing Organizations, Contract testing Labs, , raw material and component suppliers
    * Establish alert limits for application at time of product release and in the post-approval stability program based on process capability, analytical method variability, and the stability profile of each drug product.
    * Initiate and maintain the Quality Management System (QMS) and Laboratory Information Management System (LIMS) for Moderna

    Minimum Qualifications
    * Minimum education requirement is a Bachelors degree
    * Applied Industry Experience required 10+ Years
    * Demonstrated track record of success of in implementing and maintaining quality systems in a biopharma organization

    Preferred Qualifications
    * Degree in sciences or engineering with an MS or above preferred

    Competencies
    * Effective Communication (oral & written)
    * Problem Solving
    * Results Orientation
    * Detail Orientation
    * Highly Organized
    * Direct and Motivate with Influence
    * Negotiate Conflict Situations, Forging Alignment
    * Personal Commitment to Overarching Vision to Improve Lives of Patients in Need

    Why Join Moderna
    Moderna is pioneering messenger RNA Therapeutics, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

    Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

    Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

    Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


    Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci43OTMyMS4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t


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    Position Summary
    Moderna is seeking a Quality Assurance Specialist for a position based at their Cambridge, MA site. The individual in this role will be responsible for providing Quality Assurance (QA) support to Manufacturing, Quality Control, Analytical Development and Process Development. The individual will primarily work with Manufacturing Associates, Quality Control Analysts, and other QA Specialists in supporting clinical product manufacturing and testing. The successful candidate must have experience in a biotech or pharmaceutical cGMP environment.

    Responsibilities
    * Write, review and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
    * Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
    * Review and approve validation protocols and reports to ensure compliance
    * Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
    * Support disposition of raw materials, drug substance, and drug product
    * Review stability protocols and reports
    * Collaborate with Manufacturing to resolve equipment and process issues
    * Conduct internal audits, track progress, and trend results
    * Lead/participate in supplier audits
    * Review relevant sections of regulatory filings

    Minimum Qualifications
    * Minimum education required: BS/MS in a scientific or engineering discipline
    * Minimum experience required: Eight years experience in the pharmaceutical/biotech industry, with a minimum of four years experience in Quality Assurance

    Preferred Qualifications
    * Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical/biotech products
    * Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance
    * Experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records, etc.)
    * Solid understanding of CMC requirements for INDs, BLAs, and other regulatory filings
    * Proficiency with enterprise systems, i.e., documentation, LIMS (analytical data management), LMS (learning management systems), deviations, CAPA, etc.
    * Experience in participating in deviation investigations, determining root cause, and developing corrective action plans
    * Ability to identify technical problems and suggest resolution of the issues

    Competencies
    * Effective Communication
    * Flexibility/Adaptability to Change
    * Accountability
    * Independence/Teamwork
    * Decision making
    * Contributing to Team Success
    * Information Monitoring
    * Technical/Professional Knowledge

    Why Join Moderna
    Moderna is pioneering messenger RNA Therapeutics, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

    Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

    Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

    Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci40NjY4MS4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t


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    Position Summary
    The Director of IT business systems will play an important part toward Moderna's overall business success in supporting the high growth of the company. S/he is responsible for the digital transformation of the business processes in Manufacturing, Supply Chain and G&A and interacts directly with the business executives in those domains. S/he is ideally a seasoned IT leader with an exceptional functional expertise, and will serve as a subject matter expert in this domain. S/he has a high exposure to fundamental and innovative business processes, is passionate about automation and digitalization, and has a full understanding of the industry regulatory requirements 21CFR11 and GMP manufacturing. The director of IT business systems is responsible for the technological direction of their area of responsibilities as well as budget, contracts, and headcount.

    Responsibilities
    * Lead the IT business Systems strategic and operational planning by the evaluation, deployment, and management of future systems across the organization.
    * Manage all aspects of Application integration/configuration including functional and technical specifications, design, development and support for applications that are used by the business and operations areas.
    * Hiring/contracting the right technical leads, ensuring organization structure yields a high-performing team.
    * Oversee one or more programs to ensure that the quality and success of his projects are consistent, repeatable and within budget.
    * Ensure any risks associated with projects in his/her portfolio are managed appropriately.
    * S/he is responsible for the strategic direction of the program, ensuring the strategy is adequate, successful, followed and continuously improved

    Minimum Qualifications
    * MSc in Information Systems or equivalent
    * 8+ years of experience in introduction and roll out of business systems
    * Excellent understanding of business processes and transactions
    * Experience in Manufacturing, Supply chain process digitalization, (e.g. scheduling, planning, product costing, forecasting, etc.)
    * Expertise in cloud based systems automation and integration
    * Must have worked in an FDA regulated industry
    * Must have a strong management background and understanding of P&Ls, KPIs, and change management.
    * Knowledge of architecture, data modeling, design and use of BI/data warehouses and ETL systems
    * Experience architecting large enterprise application
    * Experience in modern cloud based application configuration and integration (e.g. SAP Hana, Veeva, Boomi, Workday, Netsuite, etc.)
    * Knowledge of Lean/Six sigma
    * Understanding of IT automation and system integration to drive efficiency

    Preferred Qualifications
    * Degree or certification in a life science discipline is preferred
    * Understanding of finance and HR processes
    * Strong people skills and ability to influence across the organization
    * Fluency in both the languages of technology and business in order to get executive and departmental buy-in on projects and changes

    Competencies
    * Effective Communication
    * Have the energy to Embrace Company growth
    * Flexibility/Adaptability to Change
    * Personal Accountability
    * Strategic Decision Making
    * Technical/Professional Knowledge

    Why Join Moderna
    Moderna is pioneering messenger RNA Therapeutics, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

    Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

    Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

    Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci4wMTMxMy4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t


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    Position Summary
    Moderna Therapeutics is seeking a Vice President of Financial Planning & Analysis. This individual will act as a strategic business partner and report to the CFO. The successful candidate will be a hands-on and participative manager and will lead efforts to support business planning, budgeting and forecasting, and special projects to support strategic and business development initiatives. This position will provide financial consulting and strategic support to senior management including preparing board presentations, financial presentations, industry comparisons, and analysis of new business development transactions. The position will interface directly with a Strategic Planning team responsible for product portfolio assessment and analysis. This position plays a critical role in partnering with the executive leadership team and in strategic decision making as the Company continues to expand its presence and enhance its mRNA programs

    Responsibilities
    * Oversee and lead the annual budgeting and planning process in conjunction with the VP Finance; administer and review all financial plans and budgets; monitor progress and changes and keep the senior leadership team abreast of the organization's financial status.
    * Work with the VP Finance to develop dashboard reports that present results in an accurate and timely manner; clearly communicate monthly, quarterly and annual results; document and explain all variances to plan.
    * Develop and lead the periodic re-forecasting process.
    * Develop business partner relationships with all cost center owners and provide financial and operational guidance.
    * Analyze present and future cost of goods trends to support strategic decision making
    * Improve demand forecasting to inform resource prioritization and capital investments in capacity
    * Support business expansion strategies by forecasting and assessing the financial impact of key decisions.
    * Develop financial models and analyses to support strategic initiatives and business development transactions
    * Support senior management team with in-depth analysis as needed

    Minimum Qualifications
    * 15+ years of experience in planning, analysis and operations in the pharmaceutical or biotechnology industry.
    * Strong quantitative, analytical skills with attention to detail and accuracy
    * Demonstrated creativity in problem solving skills to enable sound decision making
    * Strong skills in Microsoft Excel and PowerPoint
    * Ability to work in an entrepreneurial and high-growth environment, with ability to work under high business pressure with strict deadlines
    * Excellent verbal and written communication and relationship building skills
    * Ability to prioritize, negotiate and work with a variety of internal stakeholders
    * Proven ability to think strategically and have a demonstrated focus on action and implementation
    * Ability to influence the organization to implement new policies, procedures and programs

    Preferred Qualifications
    * MBA strongly preferred
    * Prior investment banking or consulting experience a plus

    Competencies
    * Effective Communication
    * Flexibility/Adaptability to Change
    * Accountability
    * Facilitating Change
    * Formal Presentation
    * Gaining Commitment

    Why Join Moderna
    Moderna is pioneering messenger RNA Therapeutics, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

    Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

    Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

    Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci4xMjU5OS4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t


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    Primary Duties Responsible for ensuring high quality of aggregate report production, Safety Review Team coordination, signal detection activities, and clinical development and product registration activities. Supports the PV Scientist B-R Assessment Team Lead to ensure that their responsibilities as PV Scientist Benefit-Risk Assessment Lead are in accordance with global regulations and in collaboration with the Pharmacovigilance physicians and other key PVRM and R&D stakeholders.

    Responsibilities 10% Management/oversight. May act as a functional line manager to PV Scientists or a manager for defined deliverables. Oversight and assumes responsibility for assigned aggregate reports, products and PV activities. Supports an organizational structure that meets the evolving needs of Shire and the PVRM department. May be responsible to manage the personal development, objective setting and performance assessment of direct reports. Fosters a collaborative culture within the product team and to external stakeholders. Ensures therapeutic product governance and communication in support of the PV Scientist Benefit-Risk Assessment Team Lead, Therapeutic Area Head, Head of Shire Pharmacovigilance and Risk Management and the Qualified Persons for Pharmacovigilance, including the EEA QPPV. 50% Aggregate report production. Responsible for the production of periodic and ad-hoc safety reporting for marketed products, where Shire is the Global Safety Database holder. Establishes project management responsibility for aggregate reports (e.g. PBRER, DSUR, topic reports) to ensure effective planning such that stakeholder input is requested/received for applicable sections of the report and regulatory timelines are met.

    Collaborates with the PV physicians to ensure that all information is available to allow for informed medical review and benefit-risk assessment. Responsible for the quality of the final document and utilizes Shire's EDMS system to provide quality control. 30% Oversight of Signal detection from Regulatory Databases and SRT Support. Responsible for the technical and scientific support of signal detection from regulatory databases (e.g. AERs and Eudravigilance).

    Responsible for ensuring that signals are triaged, assessed and safety topic reports produced if required. Liaise with PV Scientist Development Team and PVRM Physicians to alert the Safety Review Team of potential risks. Oversees vendors/ CROs performing activities related to data mining. 10% Support for registrational/ labelling activities. Responsible for authoring labelling justification documents as required. Education and Experience Requirements Life Science Degree or Healthcare Professional. Post-graduate qualification in a relevant discipline preferred. Experience in a pharmaceutical company preparing, writing, authoring and submitting periodic safety reports. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

    Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=c3N6Y3plc255LjczMzAyLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


    0 0

    Primary Role:
    Responsible for supporting commercial biologic programs, manufacturing investigations, assay remediation and assay development. Define analytical strategy for commercial programs supporting CMC filings and process characterization; which include and are not limited to: interacting/interfacing with quality, regulatory, manufacturing, process development organizations and CMOs/CROs. Assist and take lead role in manufacturing investigations; which include and are not limited to: being analytical team member, developing the analytical strategy and methods, coordinate sampling and testing (either internally or externally), assessment of results and communicating results to team. Assist in assay remediation and assay development; participate in team meetings, develop and execute analytical plan, timelines, compile data and communicate results to team. Planning and evaluation of new (or replacement) technology/methods to support manufacturing or product release. Assist in the analysis of data generated by organizations external to MS&T. Perform data analysis to support documents for submission to regulatory agencies.

    Responsibilities: 40%:
    Designs, manages and executes analytical methods for (includes internal and external execution) to support commercial programs, manufacturing investigations, assay remediation and assay development.

    40%:
    Participate and represent Analytical MS&T group in various cross functional meetings.

    20%:
    Review manufacturing and assay documents (internal and external sources) and results to ensure technical excellence and compliance with regulatory guidelines. Assess/communicate progress to supervisor and key stakeholders within and outside the group. Education & Experience Requirements: MS with 10+ years of experience or a PhD with 5+ years of experience with analytical development of protein therapeutics and analysis of polymers and small molecules. Have experience in interacting with and understanding of manufacturing, process development and quality (control and assurance) aspects to assure compliant operations

    Other Job Requirements: Some domestic/International business travel required
    About Shire: Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.

    Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjkwOTAwLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


    0 0
  • 11/20/15--04:49: Equity Associate
  • Position description:

    This full-time position reports to the Equity Manager and is responsible for assisting with all aspects of Ironwood’s stock plan administration including stock options, restricted stock awards, restricted stock units and ESPP.

     

    Responsibilities:

    • Assist and back up the Equity Manager in the following areas of stock plan administration:
    • Daily data exchange to update participant accounts and settle trades
    • Verifying stock option exercises and preparing instruction letters to Transfer Agent
    • Creation and activation of new grants
    • Creating and maintaining participant accounts and processing termination activity
    • Calculating and maintaining tax withholding and rates; coordinating with Payroll
    • Processing manual stock option exercises and 10b5-1 same-day sales with broker
    • Processing restricted stock units releases and perform associated tax withholding activities
    • Administering ESPP including enrollment, contributions, refunds and purchases
    • Collaborate with Legal and Human Resources on equity-related issues and filings
    • Support Finance team and external auditors
    • Generate equity reports and prepare monthly and quarterly reconciliations
    • Assist with preparation and filing of Section 16 reports (Form 4) for insiders and preparation of year-end tax statements
    • Point of contact for stock participants including employees, shareholders and brokers

     

    Requirements:

    • Two years of equity administration experience
    • Hands on experience using stock plan administration systems (Equity Edge Online is a plus)
    • Strong Excel and/or Database software skills
    • Strong verbal and written communication skills
    • Exceptional attention to detail
    • Demonstrated experience maintaining confidential information
    • Flexibility and team-oriented; ability to balance multiple priorities
    • Willingness to learn new responsibilities
    • Bachelor’s degree, preferred

     


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