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Career postings for the Massachusetts Biotechnology Council

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  • 11/04/15--09:04: Part-Time Machine Operator
  • Working with minimal supervision from packaging manager, and as an integral member of the packaging team, this individual will be primarily responsible for the operation two filling lines. The hours for this position are 3:00 pm - 7:00 pm Monday-Friday.

    Primary Responsibilities:

    • Observation of daily machine operations.
    • Performance of quality controls to ensure conformity of packaged products.
    • Performance of quality checks for accuracy of labels, volumes and cap placement.
    • Routine maintenance, cleaning and adjustments or repairs to machinery and related equipment.
    • Prioritization of daily production runs based on demand.
    • Maintenance of run records and machine logs. 

    Qualifications and Experience:

    • HS diploma or GED.
    • Be goal and deadline oriented within a team framework with exceptional attention to detail.
    • Have a strong work ethic, emphasizing both efficiency and quality of work.
    • Have strong mechanical background, preferably with filling machine experience.
    • Be highly flexible and willing to work in a fast paced environment. 
    • Have experience with automation control systems.
    • Have the ability to read wiring schematics.

      

    New England Biolabs is an Equal Opportunity/ Affirmative Action Employer of Minorities, Females, Disabled and Protected Veterans 

     Candidates may apply online at www.neb.com or by accessing the following link: Part-Time Machine Operator


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    Mersana Therapeutics, Inc. is a privately-held, biotechnology company focused on developing novel Antibody Drug Conjugates (ADCs) for various oncology indications.  Our pipeline is derived from our highly differentiated drug conjugation platform which is based on Fleximer®, a clinically validated, biodegradable, biocompatible polymer. In March 2015, Mersana closed a Series B financing, led by New Enterprise Associates, and joined by Pfizer Ventures, Fidelity Biosciences and Rock Springs Capital Management. The proceeds of this financing are funding Mersana’s ongoing efforts to develop its next-generation ADC technology.

    Mersana engineers novel antibody-drug conjugates (ADC) that maximize the potential of new and established therapeutic classes. Our technology harnesses the power and synergy of polymer science, biologics and small molecules.

    We are seeking an experienced and highly motivated candidate to join our research group focusing on development of novel targeted therapeutics in cancer. 

    The Antibody-Drug Conjugates Research Associate/ Associate Scientist will support the biological evaluation of antibody drug candidates for oncology applications, including proof of concept, target validation, and efficacy studies.

    Education and Requirements:

    • BS/MS in life sciences with 5+ years of industrial or academic laboratory experience in oncology, biotherapeutics, or immunology
    • Expertise in antibody biochemical characterization assay development and application (ELISA, flow cytometry, Western Blot, multiplex assays), experience in antibody engineering and production is a plus
    • Hands-on experience with cell culture techniques including in vitro functional assays
    • Working knowledge of general biochemical and molecular biology techniques; Exposure to histology and immunohistochemistry a plus
    • Strong interpersonal skills, ability to collaborate across disciplines, and effective communication skills
    • Highly analytical mind, attention to detail, and outstanding time management and organizational skills are essential

    Compensation will be commensurate with experience and level of responsibility.

    Position is eligible for bonus, option awards and benefits including medical and dental coverage, life insurance, 401(k) with employer match, vacation and paid holidays.  

    Candidate must be authorized to work within the US.  

    Mersana is an Equal Opportunity Employer.


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    Mersana Therapeutics, Inc. is a privately-held, biotechnology company focused on developing novel Antibody Drug Conjugates (ADCs) for various oncology indications.  Our pipeline is derived from our highly differentiated drug conjugation platform which is based on Fleximer®, a clinically validated, biodegradable, biocompatible polymer. In March 2015, Mersana closed a Series B financing, led by New Enterprise Associates, and joined by Pfizer Ventures, Fidelity Biosciences and Rock Springs Capital Management. The proceeds of this financing are funding Mersana’s ongoing efforts to develop its next-generation ADC technology.

    Mersana engineers novel antibody-drug conjugates (ADC) that maximize the potential of new and established therapeutic classes. Our technology harnesses the power and synergy of polymer science, biologics and small molecules.

    We are seeking an experienced and highly motivated candidate to join our research group focusing on development of novel targeted therapeutics in cancer. 

    Mersana is seeking a highly motivated candidate to join our Analytical Chemistry group and work as a member of a cross-functional research team.

    Key Responsibilities:

    • Under guidance from the senior scientists perform RP/IEX/SEC HPLC, LC/MS, CE/cIEF and spectrophotometry based testing of research materials including small molecules, polymers and biologics
    • Perform HPLC and LC/MS analyses and routine maintenance on analytical instrumentation including Shimadzu and Agilent HPLC systems, AB SCIEX 3200 Q-Trap, ThermoFisher Q-Exactive LC MS/MS system
    • Participate in the development/evaluation of new analytical methods to support our growing drug pipeline and assist our synthetic chemistry group with their sample preparation and analysis
    • Prepare calibration standards, buffer solutions, schedule and perform routine maintenance on analytical instrumentation
    • Schedule, implement method development and research activities; maintain accurate laboratory records and notebooks; follow analytical procedures and validation protocols in compliance with regulatory requirements and industry standards; write analytical reports and SOPs
    • Maintain laboratory supplies and perform laboratory housekeeping tasks
    • Under guidance from the senior scientists develop and validate new analytical/bioanalytical methods for research materials evaluation

    Education & Requirements:

    • B.S. or M.S. degree in chemistry, biochemistry, or a related discipline with 3+ years of industrial experience preferably within the pharmaceutical company setting or a CRO
    • Hands on experience in instrumental analysis, including operation, and maintenance of HPLC and MS instrumentation is required
    • General wet chemistry skills
    • Experience with AB Sciex, Thermo, and Bruker mass spectrometers and Beckman CE systems is desirable
    • Knowledge of HPLC and LC/MS analytical software, e.g., Chemstation, Analyst, DataAnalysis, Xcalibur is desirable
    • Experience in sample analysis from biological matrices is desirable
    • Fluent English language skills - oral and written, computer skills (Excel, Power Point, Word) is required
    • Ability and desire to learn, and develop new laboratory skills
    • Has collaborative teamwork and communication skills, is energetic, highly self-motivated and able to work efficiently and productively in a start-up company environment

    Compensation commensurate with experience and level of responsibility.

    Position is eligible for bonus, option awards and benefits including medical and dental coverage, life insurance, 401(k) with employer match, vacation and paid holidays.

    Candidate must be authorized to work within the US.

    Mersana is an Equal Opportunity Employer.


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  • 11/03/15--23:23: Data and Analytics Lead
  • The Clinical Data Sciences (CDS) department is strategically focused on clinical data, optimizing the data flow from CRF to Submission including but not limited to Data Management and Statistical Programming. The four areas of focus for CDS include Data Planning, Data Operations, Data and Analysis Infrastructure and Quality and Process Management. The Data and Analytics Lead (DAL) role is part of the Data Operations group. This role has a focus on Early Clinical Development, include pre-clinical, Phase 0 and Phase 1 studies.


    The Data and Analytics Lead manages the end to end clinical data flow (data acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR) to Electronic Submission (ESUB) of Clinical Data) and ensures timely project execution; recognized as an operational specialist in data flow and study execution by all functions across Development Sciences. Partners with CDS Data Strategy Lead and key study team members to facilitate implementation of a robust and clear Data Strategy for assigned studies. Uses phase, TA and operational knowledge to establish study level operational plans and oversees CROs and other vendors to ensure timely execution. Develops study level quality plans and ensures adherence and consistent execution across the data flow. Collaborates with Program DALs to ensure alignment of study operational plans with program goals and for execution and quality.


    • Develops timeline and project manages all end to end data and statistical programming and submission deliverables in collaboration with cross functional team members and vendors.
    • Oversees execution of data management and statistical programming/electronic submissions deliverables. Interprets and applies data strategy, verifies consistency and usage of data, results and submissions standards, Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data.
    • Develops risk mitigation or action plans and oversees execution when appropriate.
    • Primary contact between CDS and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (CDS functions, GCO, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel)
    • Serves as Subject Matter Expert for data, reporting, and analysis process definition, improvement, and innovation as needed.
    • Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed.
    • Support study-level audit and inspection readiness activities as needed.
    • Serve as project manager on special projects and initiatives; partners with Statistical Programming, Vendor Management and Quality depending on type of project.


    Requirements:

    • Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
    • 8+ years relevant work experience with a focus on data management and/or data analysis
    • Deep understanding of drug development and biopharmaceutical industry required
    • Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable


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  • 11/05/15--09:00: Statistical Programmer
  • Position Summary
    The Statistical Programmer provides Statistical Programming technical leadership and support to team members. He/She delegates tasks appropriately and tracks progress. The Senior Statistical Programmer may also construct estimates of project resource requirements and time lines and routinely briefs management on accomplishments, status of projects, and any issues. In addition, the Senior Statistical Programmer is a designated member of clinical sub-team(s) in the role of project lead Statistical Programmer for a limited number of studies. KEY

    RESPONSIBILITIES: Advance those of the Statistical Programmer to include the following: Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from supervisor Provides guidance on the resolution of highly complex clinical trial reporting problems within budget and time line constraints, while assuring high quality standards Performs quality control checks of advanced SAS code and output produced by other Statistical Programmers Responsible for maintaining excellent working knowledge of medical data, the design and phases of clinical trials, statistics, relevant regulatory requirements, and the pharmaceutical industry Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications) May conduct briefings and participates in technical meetings for internal and external representatives (e.g., IS, CROs, Clinical Development Partners, Software Vendors, FDA, EMEA, et cetera), on assigned projects Manages project timelines and schedules of specific phases of projects and contracts with internal personnel and outside customer representatives. Performs other duties as assigned

    Requirements
    In addition to the attributes of a Statistical Programmer: Proven record of effective and successful project management tasks and skills Demonstrates advanced experience with all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH Demonstrates advanced knowledge of electronic submissions and CDlSC Displays highly advanced knowledge regarding software validation and system development life cycle concepts Communicates effectively in verbal presentations and written technical reports to both internal and external customers PREFERRED EDUCATION AND EXPERIENCE: M.S. (or equivalent degree) and 3-5 years of relevant work experience, or B.S. (or equivalent degree) and 5-7 years of relevant work experience Extensive CDISC (SDTM and ADaM) experience


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  • 11/05/15--09:00: Project Manager
  • SUMMARY:
    Manages multidisciplinary project teams to assure accurate and timely completion of all contracted activities. Designs, communicates and implements project plans and manages project budget.
    The Project Manager will work with senior members of the Program Management department in management and development of cross-functional programs, business processes, and business initiatives. The Project Manager will work closely with Program Managers (PMs) to ensure timely completion of deliverables required for ensure robust and balanced cross-functional planning, decision-making, implementation and monitoring of the programs. He/she will also contribute to the development and execution of cross-business initiatives and processes.

    Requirements
    Requires a minimum of 5 years of experience in drug development in a pharmaceutical environment and a minimum of 2 years of functional or cross-functional project or program management experience.


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    Position Summary

    This individual will ensure demand requirements for future purchases, productions and changeover are accounted for, the capacity is available and ensure material and resources are available for continuous processing. This is a cross functional position requiring meetings with project teams to determine timelines for upcoming batches, projects or initiatives. Projections and presentations of plan and schedule as well as risks to meet deadlines will be required.

    Responsibilities (other duties may be assigned as needed)
    * Ability to effectively communicate and collaborate with all levels in the organization
    * Lead cross-functional teams to ensure business objectives are achieved
    * Recognition of supply chain risks and take action to mitigate
    * Works with others to effectively achieve goals
    * Ability to remain flexible/adaptable in order to function in a tactical environment while maintaining focus on strategic organizational goals
    * Execute purchases within cGMP standards using Approved Supplier List
    * Managing Suppliers to ensure product and services meet specifications
    * Assist material handling personnel as needed
    * Ensure accuracy of detail to inventory, materials purchased and production build plan
    * Document all transactions, including deviations, OOS, CAPA, etc... according to protocols.
    * Write and maintain accurate protocols within the quality system
    * Build forecast demands, interact with management, business development and finance to negotiate and procure materials.
    * Lead and/or participate in Quality Agreements, MSA's and Supplier Audits as necessary

    Minimum Qualifications
    * BA in life/physical sciences or in business or associated area
    * Minimum of 1-3 years' experience in a GMP manufacturing environment
    * Experience particularly in planning and scheduling.
    * Understanding of inventory control tools like MRP/ERP systems.
    * Knowledge and application of project management methodologies
    * Strong organization skills
    * PC skills and ability to create and present data

    Preferred Qualifications
    * BS in life/physical sciences or in business or associated area
    * 3-5 year's experience in a GMP manufacturing environment
    * Hands on experience using MRP/ERP systems
    * Proven record of managing cross-functional team projects and presenting to management

    Competencies
    * Aligning Performance for Success
    * Building Partnerships
    * Communication
    * Customer Focus
    * Detail Oriented
    * Energy
    * Impact
    * Initiating Action
    * Negotiation
    * Planning and Organizing
    * Quality Orientation
    * Safety Awareness
    * Stress Tolerance

    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=YWxsaXNvbi5tYXllci4zMTIyMi4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t


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    Role Description
    The Culture Process Development (CPD) group of Pfizer in Andover, MA is seeking a highly motivated and energetic scientist/engineer interested in cell culture bioreactor process development. The CPD Senior Scientist will work with a larger team of scientists responsible for the development, scale-up/scale-down and characterization of mammalian and/or microbial culture processes, and associated regulatory filing activities. She/he will work closely with project management and Bioprocess R&D functions to drive thoughtful, efficient, and timely development and transfer of suitable processes to clinical manufacturing to meet supply objectives for clinical materials and work across sites to ensure that best practices are employed. The CPD Senior Scientist will also ensure the delivery of a robust culture process to commercial manufacturing.

    Responsibilities
    The successful applicant will join a team of scientists and engineers focused on developing and optimizing cell culture processes for recombinant proteins and biologics for early- and late-phase clinical trials. He/she will be responsible for designing and executing cell culture experiments in a variety of types and scales of equipment from bench top to pilot-scale and, as required, technology transfer and validation in commercial plants. The candidate will be responsible for evaluating the effects of cell culture medium formulations, bioreactor process parameters and novel technologies on process performance and product quality attributes. The candidate will be responsible for supporting transfer of robust, efficient, and scalable cell culture processes to clinical and commercial manufacturing facilities. Requires demonstrated competency in aseptic laboratory technique and the ability to design complex experiments and interpret data. Requires demonstrated effectiveness in c
    ollaborative projects, and ability to communicate effectively with scientists and management in a highly matrix organization. Ensures effective, high-quality, timely and appropriate documentation in electronic laboratory notebooks and internal Technical Reports; contributes to Regulatory Filings and responses to Regulatory questions; presents data/ strategy to scientists and management in appropriate internal and external venues (technical meetings, Project Team meetings, conferences) and publishes in peer-reviewed journals, as appropriate.

    Qualifications
    - PhD. or equivalent in the area of Chemical/Biochemical engineering, Cell Biology, Biochemistry, or Microbiology - recent graduate are encouraged to apply.

    Technical Skills Requirements, relevant and substantial experience in some or all of the following areas:
    -Strong mammalian cell culture expertise plus knowledge pertaining to other heterologous expression systems
    -Ability to work independently on projects with long-term goals, and also as part of an integrated group on various protein-based human pharmaceutical project teams
    -Excellent oral and written communications skills
    -An in depth understanding of mammalian cell biology would be particularly desirable
    -Expert knowledge and experience in using systems biology approach to gain deep biological understanding
    -Scale-up/ Scale-down of bioreactor processes
    -Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams

    Physical/Mental Requirements:
    Position requires occasional light lifting and periods of standing, sitting or walking. Some regular air travel required.

    Work Schedule/Travel:
    Occasional weekend work required
    Travel

    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=QWxpc29uLlR1dGx5cy4xMzAyNi4zMTY3QHBmaXplci5hcGxpdHJhay5jb20


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    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 qualified candidate will operate within the Pharmacokinetics, Dynamics and Metabolism (PDM) group in a project team setting and provide global biomarker ligand binding and immuno-assay based bioanalytical support for regulated (GLP/GCP) preclinical and clinical development for multiple therapeutic areas. Provide scientific support and routine sample analysis for the development and application of efficient, quantitative soluble-biomarker bioanalytical chemistry solutions for the sake of assay development, characterization, translation, execution, and validation in support of Research Project teams.

    Responsibilities
    -Responsibilities include the quantitative analysis of novel biomarkers utilizing immunoassay techniques. Successful job performance includes development, characterization, & implementation of appropriate ligand binding assay techniques and related sample isolation technology for supporting quantitation of large molecule biomarker species.
    -Routine use of liquid handling systems, various immunoanalytical platforms (ELISA, MSD, Singulex, Gyros, SiMoA etc), and Watson LIMS are required. Position requires expertise in biological sample handling and preparation, and laboratory automation.
    -Role includes planning of laboratory activities with key stakeholders and senior leaders, understanding and influencing therapeutic area biomarker strategies to use biomarkers in scientific decision-making.
    -Successful performance includes participation in all phases of bioanalytical laboratory operations including technology evaluations, the development of sample preparation, separation and detection methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.
    -Proactively gathers input from colleagues, teams & management to avoid/address issues at functional level and participates on cross discipline matrix teams
    -Excellent oral/written communication skills
    -Demonstrated ability to clearly & concisely communicate bioanalytical information (including Q&A)
    -Understanding of "fit-for-purpose" assay development and support. Ability to effectively balance assay rigor against resource needs and study goals
    -Knowledge and understanding of GLP/GCP guidance for execution of preclinical and clinical studies supporting NCE's

    Qualifications
    Bachelor degree or Master Degree in relevant scientific field with 3-8 years of experience

    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=amlsbC5jdXR0aW5nLjQyOTQzLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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  • 11/05/15--02:19: Research Scientist I
  • The successful candidate will play a key role in developing and implementing technologies for functional genomics in mammalian cells, with a focus on CRISPR technology.

    She or he will design and perform experiments using molecular biology techniques and genetic manipulation of cell lines, with support from research associates.

    Scientific priorities will include developing new methodologies for genetic screens and novel technologies for functional genomics, and the candidate will be encouraged to develop independent research projects over time.

    The successful candidate will have the opportunity to make impactful contributions in a fast-paced and dynamic research environment at the cutting edge of biomedical research.

    PhD

    EOE/Minorities/Females/Protected Veterans/Disabilities

    To apply for this position, please CLICK HERE


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  • 11/05/15--02:28: Research Scientist I
  • The Center for the Development of Therapeutics is in search of a highly motivated and capable chemist to join a multidisciplinary team working on targeting the regulatory networks governing gut mucosal immune responses for therapeutic impact. The role is primarily centered on hit-to-lead efforts. Knowledge or experience with biophysical methods for compound optimization, fragment-based lead discovery, and structure-based design would be beneficial.

    Overall Responsibility
    The successful candidate’s primary role will be in medicinal and synthetic chemistry with the responsibility for advancing lead discovery through the design, assessment, and successful execution of routes to key compounds as part of an integrated lead discovery effort.

    Characteristic Duties
    - Contribute ideas, along with chemistry, biology and pharmacology team members, to identify critical experiments for rapid compound progression.
    - Multi-parameter optimization of lead series targeting a profile suitable for in vivo target evaluation.
    - Independent investigation and execution of a variety of modern chemical transformations along with purification and characterization of compounds by contemporary methods (e.g. HPLC, flash chromatography, NMR, MS etc.).
    - Maintaining the highest of professional standards for laboratory safety and record keeping.
    - The preparation and effective communication of results in oral and written form.
    - Present results at team meetings and externally and contribute to the writing of research papers.
    - Ph.D in synthetic chemistry with 0+ years of post-degree research experience in an academic or industrial settings.
    - A demonstrated ability to design and complete novel multi-step synthesis routes and/or multi-parameter compound optimization exercises.

    Evidence of innovative solutions to complex synthesis problems a plus.

    - Ability to plan and design project deliverables with support from project lead.
    - Working knowledge of techniques related to purification and characterization of compounds is required.
    - Experience in 2D NMR methods for small molecule characterization is desired.
    - Candidate should have an outstanding academic and professional record of accomplishments.
    - Candidate should be an innovative, data-driven, analytical thinker with strong interpersonal and communication skills.
    - Must be highly disciplined, organized and motivated, with first class record-keeping skills.

    EOE/Minorities/Females/Protected Veterans/Disabilities

    To apply for this position, please CLICK HERE


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    Requisition Title

    Business Analyst- Lab Systems

    Type

    Contract

     

    Description

    We are seeking a Business Analyst to support the R&D laboratory requirements of the Vaccines Business Unit (VBU). Currently VBU R&D operates in facilities in Montana, Wisconsin and Colorado, and will begin consolidating to new laboratories in Cambridge, MA in 2016. The Business Analyst will have a key role in developing requirements for and planning the new lab IT environment with VBU scientists, coordinating transition of laboratory IT, any GxP validation and/or PC tech refresh or re-imaging efforts, and onboarding into Cambridge systems for instrument data management. Absolutely critical is the ability to collaborate and align with IT service functions and R&D IT to ensure the least disruptive transition of our scientists and laboratories into Cambridge. 

    The Business Analyst will:

    • Develop, document, and conduct periodic inventories of VBU laboratory systems and key peripherals such as barcode printers & scanners.
    • Analyze, identify, plan, and coordinate or implement enhancements, upgrades, and/or solutions to improve the overall support of laboratory IT environments.
    • Troubleshoot client instrument workstations and network connectivity and coordinate/collaborate with instrument repair/maintenance providers.
    • Collaborate with network, desktop services, Helpdesk, and Research/CMC IT staff to ensure proper operations in the labs. 
    • Develop or adapt vendor documentation for instrument software validation, workstation qualification, and execute GxP validation test scripts.
    • Work with IT engineering teams in the development of GxP and research laboratory images, and packaging of laboratory software. 
    • Provide project support for laboratory informatics platforms such as electronic laboratory notebook, Waters Empower, NuGenesis SDMS, Agilent Chemstation, and Analyst as these are deployed in laboratory environments.
    • Collaborate with Vaccines operations, facilities lab services, and IT service teams and vendors in the review, planning, and onboarding of new instrumentation.
    • Support the effective use of electronic lab notebook or off-instrument analysis inside the various laboratory environments through planning & implementing such things as kiosk or mobile PCs, remote or virtual desktops, etc. 

    SKILLS:

    • Bachelor's Degree and five years’ hands-on experience in IT support of biotech/pharmaceutical laboratory environments.
    • Requires technical experience with but not limited to Windows technologies, networking, remote computing, virtualization, bar code technologies, and key laboratory instrumentation (purification, analytical, cell culture, and liquid handling robotics, for instance) and informatics platforms
    • Experience working within a regulated environment and in BL1/BL2 laboratories and support areas
    • Honed analysis and problem solving skills, proven customer relationship and communications skills, and team behaviors
    • Experience with Macintosh or UNIX platforms in the lab is a plus

     


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  • 11/05/15--05:42: Clinical Project Lead
  • Position Summary

    • Direct the creation and execution of clinical trial activities in accordance with SOPs, ICH Guidelines, and Good Clinical Practice (GCP).
    • Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection. 
    • Lead cross functional clinical study team to achieve study milestones.
    • Interact with internal and external groups to achieve study milestones.
    • Determine study requirements, define specifications, and initiate and lead the selection of third party vendors.
    • Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget and quality 
    • Manage clinical study budgets within agreed variance.
    • Communicate clinical studies performance data to other members of the management and scientific team.
    • Prepare and maintain required study and regulatory documentation, e.g., reports for Competent Authority submissions, template informed consent, Monitoring Plan, Pharmacy Manual, investigator contracts and budgets.
    • Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report. 
    • May provide input into the clinical development strategy for assigned study including but not limited to operational feasibility, budget and timeline estimates.
    • May participate in and/or lead department initiatives
    • Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices.


    Requirements

    • A solid clinical operations professional with at least 5 years’ experience in clinical research.
    • Must have proven technical leadership skills.
    • Individual must have cross-functional clinical expertise for effective problem solving and successful execution of the clinical plan for a study that includes site management & monitoring, drug supply, data management, medical monitoring, biostatistics, medical writing, drug safety, and regulatory affairs.
    • Effective verbal and written communication skills are required in relating to customers and colleagues both inside and outside the organization.
    • Knowledge of team development principles and successful implementation of the same is desirable.
    • Effective management and oversight of CROs plus a track record of ensuring GCP compliance and risk management of clinical studies is expected.

    Minimum requirement:

    • Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development. 
    • Advanced degree is desirable.
    • PMP certification desirable.
    • Excellent interpersonal and influencing skills.
    • Ability to effectively lead a cross-functional team in a matrix environment.
    • Proven problem solving and timely decision making skills.
    • Excellent leadership, risk management, planning and project management skills.
    • Strong verbal and written communication and presentation skills.
    • Ability to effectively interact with all levels of professionals and support staff.
    • Management and oversight of CROs.
    • Participate in continuous improvement initiatives in the department.
    • Thorough knowledge of global regulatory requirements and ICH/GCP guidelines essential.

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    Position Description

    Reporting to the Chief Performance Officer, the Director, Operational Excellence will support the development and delivery of a scalable and sustainable best in class operational environment for the business.  In this role, the Director will strive to optimize workflow and processes, eliminate valueless activities within processes as Aegerion grows and improve customer satisfaction and ensure improvement sustainability.

     

    This key contributor will be responsible for the thought leadership, strategy and tactics to drive a Lean implementation throughout the company.  In this role, you will take ownership in developing a best in class process improvement mindset throughout Aegerion working in partnership with each function/region and ensuring operating metrics and KPIs are aligned with business objectives. 

     

     

    Key Responsibilities

    • Owns strategic performance analysis;
    • Identifies opportunities for improvement;
    • Partners with Functions to create annual performance blueprint and prioritizes projects and process improvement opportunities;
    • Ensures Six Sigma principles are outlined in lay persons terms to create learning through each project;
    • Conducts gap analyses between desired and current states;
    • Implements change management strategies for critical business processes;
    • Facilitates Operational Excellence teams where needed;
    • Serves as a key advisor to senior leadership to prioritize and drive process improvement initiatives;
    • Practitioner of Lean Six Sigma tools and methodologies and corresponding metrics to measure performance improvement;
    • Delivers significant, quantifiable process improvement and financial benefit on assigned projects;
    • Leads by example as an effective change agent who can manage multiple projects;
    • Leads by leveraging influencing skills;

     

     

     

    Qualifications and Experience

     

    • The ideal candidate has a bachelors degree (master’s degree preferred), is a Green Belt, and has at least five years’ experience in LEAN-Six Sigma facilitation, including value streams and LEAN management systems.  Specifically, the candidate will have experience facilitating Lean Six Sigma projects within the realm of organizational development and project charters.   Other desirable attributes include:
    • Tenacity and energy in leading change towards an improved and effective work environment;
    • Excellent interpersonal skills with the ability to use tact, judgment and diplomacy;
    • Very Strong analytical and project management skills with the ability to prioritize, plan and execute on target deliverables;
    • Able to successfully manage multiple projects simultaneously;
    • Effective influencing skills and can simultaneously educate, coach and motivate a team to meet defined deliverables in a timely manner;
    • Understanding of organizational development principles and uses that knowledge to build high performing project teams.

     

    Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans

     


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    Position Description

    Reporting into the Vice President of Medical Affairs, the Senior Medical Director, Medical Affairs will be part of the Medical Affairs organization at Aegerion headquarters in Cambridge and will contribute to the medical/clinical output from that team. A key part of this role will be to serve as the primary internal reviewer and signatory of promotional materials as well as medical materials.  The Senior Medical Director, Medical Affairs will also interact with and progressively contribute to other internal Medical Affairs functions, including Publications, Medical Information, Grants, Medical Communication, and MSLs.  .

     

    In a matrixed fashion, the Medical Director, Medical Affairs will work with all members of the Medical Affairs team and will develop strong relationships with other internal colleagues cross-functionally including Sales and Marketing, legal, regulatory, and clinical.   

     

     

    Key Responsibilities

    • ·       Review of promotional materials and activities for US and International regions
    • ·       Review of Medical materials for US and International regions
    • ·       Serve as the primary medical partner for Sales and Marketing with respect to helping with the development of medical/scientific content in Sales/Marketing materials
    • ·       Responsibilities in International markets as directed as primary Medical Affairs MD, including:
      • o   Perform medical/scientific training on lomitapide to Sales and other internal clients
      • o   Provide Medical support for communication with and presentations to private and public payors;
      • o   Provide Medical Intelligence and support at relevant medical congress meetings;
      • o   Establish strong relationships with and good scientific communication with KOLs and patient advocacy groups;
      • o   Provide medical input to and oversight of the lomitapide patient support program
      • o   Represent Aegerion at external meetings, such as Advisory Board meetings and medical conferences;
      • o   Assure compliance with laws, regulations and applicable codes.

    Qualifications and Experience

    • ·       M.D. degree, ≥5 years of experience in the biotechnology or pharmaceutical industry, with ≥3 being in Medical Affairs;
    • ·       Therapeutic area experience with cardiovascular or metabolic products compatible with current products and upcoming pipeline is a plus, but not necessary
    • ·       Direct involvement with promotional and medical materials review and medical support of successfully marketed biotechnology or pharmaceutical products;
    • ·       Experience establishing and managing a network of Key Opinion Leaders, with strong relationship-forming capabilities
    • ·       Experience with data mining, data analyses, and developing claims;
    • ·       Experience with Medical Affairs functions, including Publications, Medical Information, Medical Communications, and MSLs;
    • ·       Ability to work across multiple functions and to be effective in a matrix environment;
    • ·       Team oriented, strong interpersonal skills, ability to collaborate with other groups;
    • ·       Creative, ability to see the big picture without losing focus on specific tactical needs;
    • ·       Excellent communication skills, ability to effectively present complex medical information to others, including the ability to communicate with knowledgeable lay audiences (e.g., patient organizations);
    • ·       Strong negotiation and persuasion skills. Ability to negotiate at the conceptual level, holding positions and ideas without alienating the parts;
    • ·       Ability to communicate well in a diverse environment
    • ·       Ability to work in tight timelines and under pressure;
    • ·       Authentic Patient focus and public health;
    • ·       Ability to work collaboratively with existing personnel and having the network and skills to attract talent;
    • ·       Ability to travel up to 20-30% of the time initially, and eventually increasing to up to 40%.

     

    Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans


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    Position Description

    Aegerion is seeking a Senior Medical Director of Clinical Development who will develop, lead, and drive the clinical development strategy of Lomitapide, a key program at Aegerion. Lomitapide is approved for adult patients with HoFH in multiple countries around the world and new/ongoing initiatives include geographic and label expansion.

     

    This person will report to the VP of Clinical Development and be responsible for the strategic as well as tactical implementation of the filing and life cycle management (LCM) plans. This position will be expected to actively participate in strategic planning, partnering discussions, and presentations to executive committees. The Senior Medical Director will partner with multiple internal teams including Clinical Operations, Regulatory, Safety, and Program Management as well as external CRO medical monitors to ensure the success of the programs.

     

    The requirements for the position include an MD and significant experience in the pharmaceutical and/or biotechnology industry. The ideal candidate will be a clinician with an outstanding record of accomplishment in successfully leading clinical development programs. As a small, nimble, tightly focused company, Aegerion hires individuals interested in both strategic brainstorming as well as tactical implementation. This position will require a medical leader who can be actively engaged in day-to-day activities.   

     

     

    Key Responsibilities

    • Provide leadership and implementation of the Lomitapide clinical development program by managing all aspects of clinical development, including: indication strategy, the design and conduct of clinical trials, the selection of clinical trial sites, the selection & training of physicians, and the oversight, analysis and interpretation of clinical data
    • Execute the existing and planned clinical programs to support global filings
    • Provide medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
    • Work closely with Aegerion’s R&D team, regulatory affairs, and consultants to assure timely filing of all clinical applications
    • Support interactions with Health Authorities worldwide throughout the clinical development continuum through registration
    • Serve as the clinical face of the company both internally and externally, including the scientific community and key opinion leaders
    • Work closely with Pharmacovigilance teams on development of local Risk Management Plans
    • Work closely with the publication team on data dissemination strategy and implementation
    • Maintain understanding of competitor programs and clinical developments in relevant therapeutic areas and engage KOLs and consultants as required

     

     

    Qualifications and Experience

    • An M.D. with strong leadership skills and proven biopharmaceutical industry experience in later stage programs
    •  A record of accomplishment including developing, planning, designing, and executing clinical studies leading to the successful registration of therapeutics
    • Experience in supporting regulatory submissions to the FDA and other regulatory agencies
    • Strong acumen and credibility within the international medical and scientific community resulting from an exceptional background in academic medical research, publication record and patient care
    • Solid personal and professional relationships with key opinion leaders
    • Thorough understanding of the drug development process, including GCP, and experience in clinical operations
    • Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders
    • Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
    • Highly developed understanding of the external market place and scientific literature to identify long-term benefits for unmet patients’ needs

     

     

    Key Skills, Abilities, and Competencies

    • Proven ability to lead a cross-functional, matrixed team
    • Strong communication and presentation skills
    • Experience in a global organization
    • Experience developing and managing budgets
    • Excellent organizational skills and the ability to apply extreme attention to detail and organization in all aspects of work
    • Flexibility and an “all hands on deck” approach
    • Solid knowledge of GCP and regulatory requirements along with a general understanding of the drug development process
    • Travel, domestic and international, likely to be ~20%

     

    Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans

     


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    Position Description

    Aegerion is seeking a Senior Scientist, Clinical Development to support the strategic and tactical plans for the Clinical Development of Metreleptin, one of Aegerion’s key assets. Reporting to the Metreleptin Medical Director, this role will be instrumental in driving the progress of ongoing and new initiatives including geographic and label expansion. 

     

    This person will be responsible for the implementation of multiple programs:

     

    • Manage the broad Metreleptin Antibody Program which consists of multiple post-marketing commitments to investigate additional assays and determine the temporal and clinical ramifications, if any, of antibody development. This program will require strategic thinking, close collaboration with multiple internal functions, and the development and execution of prospective trials.

     

    • Support the clinical and scientific investigation of future lifecycle management (LCM) plans for Metreleptin. Based on cross functional strategic thinking, this position will take point on assessing the literature, gathering external KOL feedback via Advisory Boards, and then working closely with the Metreleptin Clinical team on trial design considerations.

     

    • Align strategic thinking and tactical execution with the Metreleptin Medical Director who leads the full development program for the asset. This position will actively support the Medical Director on multiple programs for geographic and label expansion.

     

    • Be the main point of contact from Clinical Development on multiple teams such as publications, IIS review, and data governance.

     

     

    The requirements for the position include an advanced scientific degree (e.g.- PharmD, PhD)  and experience in the pharmaceutical and/or biotechnology industry, preferably in the Clinical Development arena. The successful candidate will have an outstanding record of close collaborations across internal functional areas as well as with external KOLs.

     

    Key Responsibilities

    • Working closely with multiple cross-functional partners and external experts, develop a strategic plan for the overall Metreleptin Antibody Program and implement key components including the development of a new assay, prospective trial considerations, and post-marketing antibody testing programs
    • Drive the clinical investigation process into possible new LCM opportunities including extensive review of the literature and discussions with external experts
    • Support the Metreleptin Clinical Development program in indication strategy, the design and conduct of clinical trials, the selection of clinical trial sites, and the selection and training of physicians
    • Support existing and planned global filings
    • Work closely with the publication team on data dissemination strategy, implementation, and data QC reviews
    • Support the ISS review team with Clinical Development input as needed
    • Serve as a clinical face of the company both internally and externally, including the scientific community and key opinion leaders
    • Maintain understanding of competitor programs and clinical developments in relevant therapeutic areas and engage KOLs and consultants as required

     

     

    Qualifications and Experience

    • An advanced scientific degree (e.g.- PharmD, PhD) with strong communication skills and proven biopharmaceutical industry experience, including trial design and implementation
    • Strong acumen and credibility within the medical and scientific community resulting from an exceptional background in the clinical arena
    • Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders
    • Solid personal and professional relationships with key opinion leaders
    • Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
    • High level understanding of the drug development process, including GCP
    • Highly developed understanding of the external market place and scientific literature to identify long-term benefits for unmet patients’ needs

     

     

    Key Skills, Abilities, and Competencies

    • Proven ability to function successfully in a cross-functional, matrixed team
    • Proven ability to drive medical programs associated with key corporate goals and cross-functional needs
    • Strong communication and presentation skills
    • Excellent organizational skills and the ability to apply extreme attention to detail and organization in all aspects of work
    • Flexibility and an “all hands on deck” approach
    • Travel, domestic and international, likely to be ~15%

    Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans

     


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  • 11/05/15--06:21: Director, Total Rewards
  • Position Description

    Aegerion Pharmaceuticals is seeking a Director, Total Rewards to oversee the Company’s Compensation, Benefits & Mobility related programs, policies and practices globally.  This position will play a key role in the design, implementation, and administration of the company’s global total rewards programs, including variable pay and equity programs, with primary responsibilities to include:

     

    Key Responsibilities

    • Manage the development, implementation and administration of competitive compensation programs, including incentive and equity plans, which align Aegerion’s compensation strategy with the competitive marketplace.
    • Oversee the Company’s benefits programs to ensure that they are designed to be market competitive and cost efficient.
    • Provide guidance and make recommendations to all levels of line management on compensation issues, policies and procedures, and interpret local, state, and federal laws regulating compensation practices. Build effective partnerships with managers and HR, providing guidance and education through one-on-one meetings and shared learning opportunities. 
    • Identify and implement compensation & global mobility processes and tools to create greater efficiency and accuracy. On an as needed basis, prepare special studies and recommendations on subjects such as incentive compensation, bonus plans, sales compensation, equity compensation, etc. Monitor compensation practices, analyze trends, and define comparison markets and peer groups, contributing to the overall compensation philosophy. 
    • Lead the annual Compensation/Merit Review      Process, ensuring timelines and program objectives are met and compiling a      comprehensive analysis of the results.       Effectively manage the promotion and adjustment process, developing      effective salary recommendations, administering the entire process, and      monitoring cost and budget limitations.      
    • Participate in multiple compensation      surveys and networking groups to ensure base pay, equity and incentive      programs remain competitive, in compliance and designed based on industry      best practice.  Develop salary      structures and analyze competitive positioning on an ongoing basis.
    • Apply job evaluation techniques to      establish competitive and equitable compensation rates; develop job      families and career ladders; and write job descriptions and      specifications. Manage the design, implementation, and communication of      new job families and career levels, gaining key stakeholder feedback and      aligning current positions and pay across groups.

     

    Qualifications and Experience

    • Bachelor’s degree and a minimum of 10 years of progressive experience in Compensation, with at least 5 years within the biotech/Pharma Industry preferred;
    • Solid experience with incentive and equity plans required;
    • Ability to develop clear, actionable steps to support the overall compensation strategy;
    • Effective team player and collaborator across HR Function and overall company;
    • Highly analytical with strong Project Management skills;
    • Strong communications skills and the ability to work within a complex, fast-paced entrepreneurial environment are critical to the long-term success of this position.

    Aegerion Pharmaceuticals is an Equal Opportunity/Affirmative Action Employer: Minorities/Females/Disabilities/Veterans

     


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  • 11/05/15--06:28: Clinical Research Associate
  • Position description:

    Ironwood Clinical Operations seeks a motivated and enthusiastic clinical research professional who shares our passion for bringing innovative medicines to patients. The Clinical Research Associate (CRA) is an integral member of our clinical trial teams; the primary responsibility of the CRA is to visit clinical research sites and monitor site progress and GCP adherence for Phase 1–4 clinical trials. The Clinical Research Associate’s assignment will involve field monitoring for multiple clinical research studies.

    Responsibilities:

    • Collaborates closely with Ironwood clinical trial sites, clinical trial managers and clinical research coordinators, cross-functional study teams, and CRO partners;
    • Evaluates qualifications of clinical research sites; oversees clinical trial investigator progress and good clinical practice (GCP) adherence through ongoing clinical trial field monitoring and reporting;
    • Assists the Ironwood clinical project teams in project related activities, such as creating study binders, shipping study documents;
    • Participates in study team meetings providing frequent field monitoring updates;
    • Reviews and tracks clinical trial regulatory documents;
    • Assists in the planning and preparation for investigator meetings;
    • Works closely with Ironwood Clinical Research Coordinators and CROs to ensure adequate clinical trial documentation;
    • Completion of telephone logs, notes to file, and status reports;
    • Frequent travel is required. 

    Requirements:

    • B.S. or equivalent;
    • At least two years clinical research experience;
    • Prior field monitoring at a CRO or biopharmaceutical company is required;
    • Superior understanding of Microsoft Office products;
    • Aptitude for organizational detail and strong analytical skills;
    • Capacity to complete tasks independently in a highly-regulated environment;
    • Flexibility to function well within a team environment and flexible to changing timelines and challenges;
    • Ability to verbalize complex study issues and demonstrated problem-solving ability;
    • Extensive understanding of FDA regulatory requirements and good clinical practice (GCP).

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  • 11/05/15--06:34: Vendor Manager
  • Vendor Manager
    Cambridge, MA

    The primary purpose of this job is to provide vendor management and other operational support to the Medical Writing function, including facilitation of contract renewals/negotiations, onboarding and provisioning new staff, including FTEs, and contractors, managing work requests, and monthly invoice/billing tracking and estimates.
    1. Onboarding and provisioning new staff (FTEs, functional service providers, and other contract staff). Serve as initial point of contact for contract staff (will triage issues to appropriate staff).
    2. Generate and track work requests for contract projects, reconcile incoming invoices against purchase orders and enter information into database; collect monthly billing estimates from vendors and supply to Finance.
    3. Facilitate contract renewals/negotiations (generate drafts, incorporate comments, circulate to stakeholders for review, obtain signatures, create purchase orders).
    4. Responsible for providing operational support for Medical Writing and other job duties that may be assigned from time to time.

     

    Requirements
    Associate’s degree required, Bachelor’s degree preferred
    4+ yrs related vendor management and accounting/finance/contracts experience with Associate’s degree
    2+ yrs with Bachelor’s degree


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