This is a Sanofi Pasteur position in our Canton, MA location

Manager Manufacturing

Responsible for the production of viral products to meet established requirements in a cGMP manufacturing environment. Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies. Manages people within a process team to meet the site goals and priorities. Plans and initiates the production schedule, coordinating activities with Manufacturing staff and other cross functional departments. Overall responsibilities include manage and execution of upstream production processes, employee training, deviation investigations, productivity improvements, and cost control measures.

Job Responsibilities:

Manage upstream production activities in a cGMP manufacturing environment under the guidance of Director of Manufacturing. Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies. Coordinates activities with manufacturing staff and other cross functional departments. Overall responsibilities include manage execution of upstream production processes, employee training, deviation investigations, productivity improvements, and cost control measures.
• Effectively execute upstream processing steps using one or more of the following unit-processing steps:
o Static cell culture expansion steps
o Bioreactor Operations
o Harvest and Centrifugation
o Media and Solution Preparation
• Provide technical support for the execution of upstream processes for vaccine products or process improvements and document in peer-reviewed process flow diagrams, protocols, SOPs, and batch records.
• Ability to perform Mammalian cell culture and operational knowledge of Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, Incubators, pH/Conductivity meters etc..
• Document and maintain production activity records according to cGMP regulations
• Implement and reinforce practices that make safety an ongoing consideration for all operational activities leading to a safe and clean working environment. Attend all safety training and exercise self disciplined to follow all HSE policies.
• Provide support to integrate best practices, where appropriate, into manufacturing. Identify and participate in training opportunities and report new technologies and industry standards to the organization. Develop training modules as needed basis.
• Perform other duties as assigned

Job Requirements:
• Bachelors of Science in a related discipline with 5-8 years of cGMP experience or a Masters of Science in a related discipline with 3-5 years of cGMP experience
• Requires Immunization prior to performing work within the manufacturing area

This is a Sanofi Pasteur position located in our Canton, MA location. 

Quality Assurance Professional

Job Summary:

Perform QA functions supporting Bulk Manufacturing operations and provide Quality oversight to all aspects of Development, scale-up, and commercial manufacturing, testing and release. Assure compliance with current CGMPs, with an emphasis on Validation (Equipment IOPQ, Computer systems, Process Validation etc.), Investigations and Change Controls. Support quality operations and systems, such as facility/equipment, materials, production, laboratory and packaging/labeling, as applicable.

• Contribute to the development, management and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and company quality standards in support of CGxP activities. Build and Maintain Quality KPIs/ Metrics.
• Prepare, review and approve Commissioning, Qualification and Validation documentation.
• Assist with all aspects of quality systems, such as Change Control, Investigations and Corrective/Preventive Action systems to assure compliance and timely and accurate completion of reported events.
• Contribute via preparation and/or review of annual product review and updates for regulatory filing(s), as applicable.
• Prepare, review and approve controlled documents relevant to GxP operations.
• Participate and/or lead cross functional teams related to internal/external audits and regulatory inspections.

"We are an equal opportunity employer M/F/D/V"

Qualifications:

1. Minimum of a B.S. in Biology, Chemistry, Microbiology, Engineering or related field.
2. Must have previous vaccine, biologics, biotechnology, pharmaceutical or biopharmaceutical experience with some Validation Experience.
3. Must have a minimum of 5 years of relevant experience within quality.
4. Must have a demonstrated understanding and/or working knowledge of cGMP regulations.
5. Experience managing subordinates and projects preferred.
6. In addition, demonstrated excellent interpersonal skills and flexibility

Job Summary

We are currently seeking a Director of Clinical Operations who will report directly to the Chief Medical Officer (CMO). Successful candidates will be well versed in all aspects of clinical trial administration and have proven success managing trials throughout their career.

Competencies

• Knowledge of tasks and resources necessary to conduct a clinical trial
• Excellent organizational skills to mobilize and deploy resources
• Effective communication and ability to assign roles and responsibilities relevant to clinical trials
• Attention to detail; ability to acquire and analyze information to troubleshoot problems
• Excellent communication skills including oral and written
• Team building: including the ability to reach consensus and delegate when necessary
• Reasonable proficiency with computer skills to achieve goals including spreadsheet and document creation; creation and use of templates when appropriate

Education/Experience

BA or BS degree, with advanced degrees a plus. Ten (10) or more years experience in the pharmaceutical industry: large company or biotech small company experience is relevant. Vaccine experience is highly desirable. The candidate should have proven success with:

• Developing operations plans and managing Phase I-III clinical trials
• Identification and selection of investigators and sites
• Identification, selection and management of contract research organizations and other clinical trial support vendors
• Working on multi-disciplinary drug development teams

The candidate should have excellent writing, organizational, and oral communications skills.

Essential Functions

• Oversee the clinical operations and execution of clinical studies: assure that resources are identified and in place for trial conduct.
• Drive the process for CRO selection, and provide primary oversight for requests for proposals (RFPs), contract management.
• Oversee the management of CROs and/or clinical sites from study initiation to close out, and ensuring adherence to all documentation requirements and process.
• Set and manage clinical project timelines with the CMO and/or project manager to meet critical milestones; and/or escalate issues that may jeopardize timelines and deliverables.
• Work with CMO and Finance to develop budgets, accruals and track the financial status against budget.
• Oversee study logistics and monitoring activities, including patient recruitment, screening and enrollment.
• Interact with active and potential clinical investigators.
• Manage study monitoring visits, leveraging partnerships with CROs and regional monitors as necessary.
• Organize and run meetings and teleconferences that assure smooth conduct of clinical studies.
• Effectively communicate with other functional areas, such as Nonclinical, Manufacturing, and Regulatory Affairs in order to accurately coordinate clinical study activity.
• Contribute to the writing or review of protocols, study-related documents, clinical study reports and clinical sections of the Investigators Brochure, INDs/CTAs and NDAs/MAAs.
• Ensure compliance with FDA regulations, ICH guidelines for Good Clinical Practices (GCP) and the conduct of clinical trials.
• Develop Standard Operating Procedures (SOPs) and study-specific guidelines as needed.
• Hire, develop, lead and organize work and resources for clinical operations colleagues including, clinical trial assistants, clinical research associates, study managers, directors and independent contractors as necessary to achieve clinical development and corporate goals.
• Other duties as assigned.

# 1137 – Principal Scientist / Associate Director – Biology

Epizyme, named a Fierce 15 company by Fierce Biotech, and ranked #1 and #2 worldwide in the past two years by The Scientist in "Best Places to Work Industry” has grown successfully since its founding in 2007 in Cambridge, MA.  We are leading the creation of small molecule histone methyltransferase inhibitors (HMTi), a new class of personalized therapeutics for patients with genetically defined cancers. Genetic alterations in HMTs, a family of epigenetic enzymes, drive multiple human diseases. Our approach represents the future of healthcare by matching better medicines with the right patients. We seek a top notch contributor to join our culture of transparency, intensity, scientific rigor, and fun!

The successful Scientific Project Leader will report to the Director of Cell Biology.   We seek a highly motivated scientist with oncology drug discovery and development experience to lead a program with a multidisciplinary team developing novel inhibitors targeting epigenetic enzymes implicated in cancer.     

RESPONSIBILITIES

• Supervise and develop biologists
• Direct internal/external activities in the following areas:
  • Cell Biology, cell-based assays, MoA studies
  • In vivo pharmacology including oncology model development, and PK/PD/efficacy studies
  • Development of PD and patient stratification discovery biomarkers, working closely with Clinical Biomarkers group
  • Translational research and clinical support
• Initiate and manage key academic collaborations, CROs, and partners

REQUIREMENTS

A PhD  in cell biology, biochemistry, or related field with a minimum of 7 years of industry R&D experience.  Oncology experience is an absolute must.  Prior experience with people management and development is key.  A proven track record of successful drug discovery program management from biological characterization of hit-to-lead through development candidate and beyond to clinical support.  Ability to work well under pressure and drive projects that affect critical timelines.  Excellent organizational skills and attention to detail.  Success with targeted and/or novel small molecule oncology therapeutics is highly desirable.  Superb communication skills, including the ability to synthesize, frame, and present complex information to diverse audiences is essential in this culture. 

Interested candidates should submit their resumes using code 1137 in the subject line to careers@epizyme.com  for immediate consideration.

Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.

Position Summary

Oversee the information technology roadmap and resources including the operation and maintenance of all hardware and software applications ensuring compliance with FDA and other regulatory agencies.   

Responsibilities

•  Prepare and maintain IT systems plan for the company.  Identify systems requirements and propose software purchase and installation schedule.
• Work with user groups to define needs, design and implement new computer related systems appropriate to the changing business needs of the company. 
• Work with Systems Administrator to enhance, maintain and document System operations providing database administration, custom reports and end user support.
• Document procedures and protocols necessary to meet CFR Part 11 standards.  Advise management team on requirements.
• Coordinate implementation teams including vendors for new software installations.
• Provide end user support assisting with questions about systems and provide user training.
• Interface with RA/QA and users to determine validation needs.  Maintain procedures and protocols for systems.
• Oversee service(s) provided by outside systems and programming firms.

Education and Experience Required

• BS in Computer Science or a related field required
• Minimum 8-10 years related experience preferred
• Experience with cGMP validation requirements highly preferred

 Please click here to apply

https://home.eease.adp.com/recruit/?id=2615761

Financial Manager/Controller – Part-time or Full-time Position* 

Essential Duties and Responsibilities

• Perform all major accounting functions, including financial reporting
• Supervise the accounting department staff
• Oversee billing cycle
• Responsible for collections
• Manage firm-wide initiatives
• Prepare financial analyses and financial budgets

Qualifications/Requirements

• Bachelor’s degree required
• At least five years of accounting experience, including three years of supervisory experience, necessary
• Strong computer skills in MS Word, Excel, and Outlook. 
• Legal billing software experience with Omega a plus
• Excellent written and oral communication skills are essential
• Prior experience in biotechnology, pharmaceutical, or intellectual property law firm a plus

*The job requirements can be tailored to make this a part-time position.

EMD Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group. We strive to create value and benefit patients by transforming medical science into breakthrough solutions in our core therapeutic areas of neurodegenerative diseases, fertility and metabolic endocrinology, as well as oncology and autoimmune/inflammatory diseases as emerging areas of expertise.

As a member of the Global Governance team, this position serves a critical role in enabling effective drug development decision making by preparing decision makers with the basis for GDM program/project value-risk evaluation, portfolio prioritization setting and resource allocation management. High impact strategic operations and communications role supporting GDM portfolio program/project metrics management, analyses and insights

• Act as the voice and face of the team – always presenting with the highest level of engagement, professionalism, courtesy and customer service becoming a trusted member of the function as well as the broader organization.
• Key interface between decision makers, functional heads, and teams to drive excellence in operational execution of the GDM pipeline in alignment with the divisional strategy through an understanding of the state of pipeline performance.
• Interacts with executives and Research/Development/Commercial (RDC) stakeholders to understand and facilitate analysis, business insights, and reporting needs that provides context and drives effective portfolio decision making for GDM.
• Conducts multi-project analyses and derives insights that enables program/project value-risk evaluation, GDM portfolio prioritization recommendations and resource allocation decisions.
• Creates or supports presentations and reports that effectively communicate insights regarding the performance of the GDM portfolio (e.g., DPPR, GL Advisory Board, PEC, DOC).
• Ensures that reports reflect the appropriate reference information on each project in the global project portfolio (“single source of truth”).
• Develops, analyzes, tracks and communicates Key Performance Indicators (KPI) for GDM portfolio.
• Maintains real time and accurate program/project metrics (e.g., Probability of Success), quantitative and qualitative information that inform the GDM portfolio analyses and stakeholder reports.
• Proactively translate performance information into action items to improve operational efficiency and effectiveness of project teams and project deliverables.
• Set up, coordinate and lead cross-functional, multi-national and multi-cultural teams to establish new KPIs and measurements supporting improvement processes for projects and functions.

Qualifications

• Minimum 8 years experience in a global pharma or biotech organization.
• Strong project, portfolio or financial planning and management experience.
• College degree in scientific discipline, advanced degree/MBA preferred.
• Fluent English both written and verbal; French/German desirable.
• Successful track record within industry-leading pharmaceutical or biotech organization.
• Successful track record working with senior executives and teams.
• Experience as a consultant is an asset.
• Strong problem solving and analytical skills including excel-based modelling and database management.
• Experience in supporting governance and decision-making processes within a global organization.

PERSONAL SKILLS & COMPETENCIES

• High customer service mentality.
• Professional and pleasant demeanor.
• Excellent interpersonal, written and oral communications skills.
• High team orientation.
• Ability to multitask and to be flexible to work assignments.
• Ability to use critical thinking as well as intricate knowledge of the operation of the function to independently set priorities.
• Strong organizational skills.
• Attention to detail and follow-through a must.
• Proven experience and examples of developing and maintaining relationships across functions.
• Position requires both domestic and international travel up to 10% of time.
• Must be able to be flexible with work schedule in order to accommodate the varying volume of work and requests.

The Genome Sequencing and Analysis Program brings together scientists, computational biologists and engineers focused on deciphering the important information encoded in the genomes of many different species including microorganisms as well as their hosts. Understanding these components is fundamental to the study of human physiology in both health and disease. We are looking for an enthusiastic and motivated individual to establish the scientific vision of our Viral Genomics program and direct the development and implementation of research plans that ensure achievement of Program and Institute goals.The successful candidate will be responsible for setting direction and managing the Program’s efforts in viral genomics, including genome sequencing of viral strains and populations, genetic characterization of infected patients, and studies of gene expression, and immune responses in humans and animal models.

This will include the candidate’s own independent research agenda as well as oversight of collaborative projects that fulfill the goals of the GSCID. He/she will work with the GSAP co-director and leaders of the GSCID to identify scientific opportunities that are in line with the mission of the Institute and lead efforts to secure funding to pursue these. Management responsibilities include oversight of PhD and technical scientists developing projects and software tools, carrying out research, and writing manuscripts and grant applications in viral genomics. He/she will present scientific findings through research publications, seminars, talks at scientific meetings and report progress as required by funding sources as well as serve as a primary contact for members of the viral research community interested in collaborating with the Program.

CHARACTERISTIC DUTIES
• Develops the Program’s scientific goals in viral genomics and host/viral pathogen interactions.
• Manages the productivity, impact and career development of viral scientists by providing oversight of project planning, execution, analysis, publication, and grant writing.
• Develops project goals, metrics and priorities with viral scientists and collaborating researchers and helps to plan and implement complex research projects that meet Program and Initiative goals.
• Works with Platform and Program Project Management staff to oversee the implementation of scientific and logistical strategies and progress toward goals, priorities and timelines.
• Writes, assists and oversees writing white papers and grant proposals, scientific publications and reports required by funding agencies. Provides oversight to the Viral Research Scientists and Project Management staff in the preparation and submission of grant proposals, renewals, funding agency reports, biosafety, IRB and IACUC documents as well as contracts, MTAs and licenses.
• Oversees goals and budgets of viral grants and is responsible for communication of all pertinent information relevant to Platform and Program workgroups. Works with GSAP co-director, GSAP Associate Director, Genomics Platform leadership, Grants Manager and others as appropriate on financial planning, strategy, and priorities.
• Delivers scientific talks representing the Broad’s viral genomics work, prepares and shares progress updates and reports as needed by funding agency staff.
• Works closely with Program and Platform leadership to identify and pursue new, major areas of laboratory and analytical methods for analysis of viral disease.
• Assures compliance with all related requirements of funding sources and project contracts.
• Ph.D. or M.D., and post doctoral research experience in virology, molecular biology or epidemiology, or related field
• Minimum of 7 years research experience including experience with genomics, genome analysis and use of next generation sequencing data for viral or microbial genome analysis
• Documented success in writing grant applications for federal and/or private funding.
• Outstanding record of research, mentoring and management accomplishments in the area of viral genomics, high throughput sequencing or genotyping, virology, computational biology or infectious disease
• Excellent written and oral communication skills with a strong record of research publications and scientific presentations
• Dynamic leader of people with excellent interpersonal and collaborative skills to work in a team-oriented, matrix environment
• Ability to adapt to and effectively manage changes in a fast paced and dynamic environment

To apply for this position, please CLICK HERE

The Broad Institute Genomics Platform seeks to hire a Project Coordinator. The role of this individual will be to support a senior level project manager in aspects of operational and administrative tasks of numerous projects across the Genomics Platform. The key areas of responsibility will include (a) interactions with other members of the Genomics Platform, by requesting its services (ie sample acquisition, sample submission for sequencing and genotyping, and data delivery) and (b) monitoring progress towards achievement of deliverables in multiple projects. The complexity of tasks performed should grow as you become more familiar with our goals and priorities. The position overall should afford an opportunity to gain experience with aspects of Project Management in a high throughput technical environment, for organized, logically minded, ambitious candidates at early stages of their careers. The ideal candidate will be meticulous, detail oriented, enjoy working with computerized systems for recording the status of workflows, and be capable of thinking logically about research processes.

CHARACTERISTIC DUTIES
• Coordinate and monitor the genetic analysis activities through the Broad’s Genomics Platform to ensure timely and effective completion and data generation.
• Report on the high throughput activities of each project to the Broad’s Genomics Platform.
 Track the receipt and transfer of DNA from large patient sample collections for an array of genetic analysis activities.
• Manage the inventory and status of multiple large DNA cohorts
• Communicate and report to collaborating sites about the status and project requirements for multiple large scale genetic analysis projects.
• Assist with data processing and data transfer
• Assist with the submission of IRB documentation, material transfer agreements and data access agreements and other required documentation
• Generate quotes and purchase orders to initiate platform activities and projects
• Work to establish close relationships with key collaborators and platform staff to enhance knowledge flow and data distribution.
• Other tasks as required.
• Bachelor’s degree in Biology or related field, with experience in administrative tasks
• Familiarity with genetic research and with databases are both helpful but not essential
• Comfort with Microsoft Excel is essential
• Ability to thrive in a team setting with an interdisciplinary group including biologists, data analysts, computer scientists and laboratory staff is essential
• Ability to work both independently and as part of a multidisciplinary team• Ability to work in a fast-paced environment and respond to shifting priorities
• Excellent oral, written, interpersonal and organizational skills requiredBroad will not offer visa sponsorship for this position

To apply for this position, please CLICK HERE

We are looking for an exceptional self-motivated and enthusiastic individual to join a dynamic research team as a Scientific Advisor in the office of a Core Member and Director of the new Klarman Cell Observatory at the Broad Institute of Harvard and MIT. The research focuses on understanding how complex molecular networks function and evolve over time in the face of genetic and environmental changes at scales ranging from minutes to millions of years. This effort builds on breakthrough technologies and on collaborations that cut across scientific disciplines.

This research will allow the scientific community to expand its understanding of how biological decisions are made in health and disease.The successful candidate will work with the Director, Assistant Director and Senior Administrative Assistant to manage a variety of Director’s scientific affairs including working with relevant staff to coordinate all research activities, develop and implement management plans and strategies for research. A key role in this position is to assist the Director with all written communications, both general and scientific. Projects will relate to a variety of areas including genomic research with an emphasis on scientific collaboration management, fund raising, recruiting, public relations, and institute administration.

CHARACTERISTIC DUTIES
• Oversees, understands and keeps current on the range of scientific issues and projects on going in the Director’s laboratory, at the Klarman Cell Observatory and across the Broad Institute.
• Helps evaluate and organize grant and collaboration opportunities in coordination with Director, Assistant Director and Sr. AA. Sets the direction on a variety of scientific and administrative projects in consultation with the Director.
• Digests scientific literature, engages in discussions with Assistant Directors and Institute Scientists, and prepares written reports. Assists the Director in developing presentations and proposals. Presents in the Director’s absence.
• Provides oversight in managing the preparation and submission of grant proposals, renewals, and funding agency reports as well as contracts and licenses. Collects information and draft text for grant proposals, renewals, funding agency reports, manuscripts, and other written materials as needed.
• Ensures that the Director’s time is used efficiently by making recommendations concerning her use of time.QUALIFICATIONS
• Ph.D. in genetics, biology, computational biology or related field, with a minimum of 5 years of experience in a directly related research environment
• Strong skills in the strategic development and management of projects, including the ability to develop and shift plans to adjust to rapidly changing scientific priorities and technologies
• Expertise and interest in writing grants and reporting; ability to write successful grant proposals
• Ability to develop and shift plans to adjust to rapidly changing scientific priorities and technologies
• Excellent presentation skills with attention to detail and follow up and the ability to interact with multidisciplinary staff and collaborators
• Demonstrated success in scientific creativity, collaboration with others and independent thought.
• Possesses flexibility, initiative, autonomy, and a sense of team work
• Ability to manage work done through others

To apply for this position, please CLICK HERE

The Department of Communications supports the work and culture of the Broad Institutethrough writing, print and digital publications, video, website creation and management,visual design, educational outreach, internal and external events, and the Broad museum.This team of many talents works individually and in project groups to develop content,educational activities, and events that serve diverse audiences.We are looking for a talented staff writer who will employ excellent research and writingskills to produce content on a variety of media platforms that supports the needs of theBroad Institute and contributes to its internal culture. The writer will work closely withadministrative groups to identify and address communication needs by cultivating andmaintaining close relationships with key contacts on those teams. The writer will workwith supervision from the Director of Communications and receive editing input fromfellow writers on the Communications team. The writer will work with digital imagingspecialists and visual designers on content for multimedia communications and representthe Broad at internal and external functions as assigned.Key

Responsibilities:
• Monitor inquiries from the Broad community and research, write, and postanswers on the internal site.
• Create and/or maintain content on internal and external websites.
• Drive internal communications strategies, using multimedia platforms to helpadministrative and scientific groups craft messages, events, and publicitycampaigns.
• Act as an internal connector, establishing relationships across administrativeand scientific groups that help feed a steady stream of information to all ourcommunication channels.
• Write and update both official biographies of Broad community members for theexternal website and informal biographies for the internal website.
• Other communications duties as required
• Bachelor’s degree in science, communications/journalism, or related field
• Minimum 2 years of writing experience
• Excellent writing, editing, proofreading, and verbal communications skillsare required
• Demonstrated ability to gather information through interviews is preferred
• Science writing experience not required, but an interest in working in aresearch environment is preferred
• Experience with or interest in learning web publication tools is desired
• Should be comfortable in a highly visible role, with the ability to interactprofessionally with all levels of• employees
• Must be flexible and able to drive deadline-driven projects to completion
• Must be able to work independently and as part of a team

To apply for this position, please CLICK HERE

This position provides leadership and direction to the Quality Operations organization. Establishes current and long-range objectives and sets operating plans for areas of responsibility. Allocates resources - human, financial, technical etc - to fulfill near term goals and commitments while building towards sustainable manufacturing excellence. It is the responsibility of this position to motivate and lead his/her organization according to Genzyme policies to achieve business objectives that will have a major impact on the success of the Corporation. The Director, Quality Assurance will direct the day-to-day operations of QA and will provide leadership, management and oversight activities the organization.

Specific cGMP responsibilities include:
- Ensuring the management and continuous improvement of the QA Operations and Technical Services
- Directing the review and approval process resulting in timely and technically appropriate cGMP oversight of GMP operations and document
- Providing guidance to site staff on CGMP requirements
- Ensuring sound release decisions that adhere to multiple jurisdictional requirements
- Establishing and chairing the nonconformance review board for all significant deviations ensuring that sound decisions are applied to adequately investigate root cause and ensuring appropriate CAPA's and CAPA effectiveness are applied
- Quality approval for all critical risk assessments and corresponding CAPA's
- Ensuring that all product quality related decisions adhere to current GMP and regulatory requirements
- Continuously improving all Quality oversight interactions
- Providing effective Quality leadership during internal and regulatory inspections
- Ensure deviations, discrepancies, change controls, etc. are technically sound from a quality standpoint

Specific Leadership Responsibilities include:
- Ensuring compliance with all legal and business requirements and Genzyme policies and practices.
- Establishing departmental and individual goals and objectives in alignment with site goals and priorities. Identifying performance improvement targets and metrics. Ensuring capabilities and capacity in place to effectively deliver on all departmental commitments and performance targets.
- Strengthening overall leadership and organizational capabilities in area of responsibility. Building and sustaining a high performance management team and ensuring strong alignment and coordination with other functional groups at the site.
- Identifying the required resources and expertise, implementing the appropriate team/departmental structures and establishing the required processes and communications to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement.
- Identifying and communicating risks in area of responsibility and across the site; creating strategies and plans to manage risk to the operations.
- Participating in development of site long range in line with the corporate Long Range Planning.
- Ensuring effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility.
- Managing headcount and expenses in area of responsibility to meet approved spending plan while achieving all departmental commitments and project objectives.
- Motivating, retaining and developing key employees. Building and sustaining employee engagement by creating an environment within which individuals and teams can excel.
- Interacting closely with the Business Unit, relevant sites and functions to define production plans, yearly goals and budgets for reporting functions/operations as well as long range.
- Maintaining an external network of expertise and representing the company in professional organizations
- Represent the Quality organization in interactions with other functional units

Leading People
- Genzyme's leaders motivate and inspire their people and build effective teams. They manage for high performance and develop others within the organization.
- Genyzme's leaders are versatile learners who are comfortable with complexity and ambiguity. They are courageous decision makers who are candid and direct.

Leading the Business
- Genzyme's leaders understand and respond to the evolving business environment. They think beyond their sphere of influence to see what is not obvious, and create a compelling vision and direction that inspires engagement from their people.
- Genyzme's leaders continuously look internally and externally for best practices. They challenge the status quo and encourage their people to try new approaches. They have a track record of generating successful new ideas that improve business performance.

Delivering to Customers
- Genzyme's leaders understand the patient and customer viewpoint. They build trust and collaboration by delivering exceptional service while balancing the needs of the individual with the greater good.
- Genyzme's leaders set ambitious and realistic targets, drive for results, and build accountability within the organization. They set high standards and continuously improve.

Qualifications

Minimum requirements:
- Bachelor's Degree in science/engineering and 12 years of experience in pharmaceuticals or a related industry or a MS in science/engineering and 10 years experience; 8+ years in management position ; 8+ years specific Quality Assurance experience in a pharmaceutical or biotech organization
- Significant knowledge and experience with FDA/EMA/TGA/HC regulations

Preferred:

Broad Quality Assurance experience in:
- Knowledge of biotechnology processing and testing
- Proven experience in leading a multi- tiered and quality diverse operation
- Proven experience in establishing a Plant QA function for the approval of batch records, BOM, Work orders, CAPA's and Change Controls in an efficient and sound process
- Project management skills
- Thorough knowledge of GMPs
- Expertise in applying quality principles to manufacturing, facilities and engineering and laboratory testing for the manufacturing of biopharma products
- Knowledgeable of requirements for post approval changes and of information typically found in the CMC sections of regulatory submissions
- Knowledge and experience with discrepancy investigation and lot disposition
- Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives. Strong collaboration skills.
- Excellent communication skills, good presentation and influencing skills and the ability to interact and gain the support of senior management
- Driven with a strong focus on goals

To apply for this position, please CLICK HERE

Our client seeks an experienced LIMS Data Associate to cover an increased work load associated with initiation of data into LIMS / AD data management systems.  The position will be focused on sample log in/verification of all incoming samples from Process Development. This includes routine checks of sample logins to ensure all discrepancies are accounted for and resolved in a timely fashion and verification of test results are tracked and archived in a timely manner. You will also assist in data entry and review of method results in LIMS when needed and will ensure user data integrity, documentation and record attributes as well as help with equipment checks as well. This position requires a BS in a sciences related discipline with a minimum of two years of relevant experience.  Knowledge of a LIMS system and ELN’s is required as well as experience working within a GLP/GMP environment.

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

StratAcuity, CHEMISTRY IS EVERYTHING.

Senior Expert Statistician

 Job Summary:

EMD Serono, Inc., a leader in the US biopharmaceutical industry, is a subsidiary of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical group with 40,000 people world wide. For our offices located in Billerica MA, we are currently seeking Senior Statisticians at an expert level.

Your primary responsibility will be to provide statistical leadership for clinical development projects throughout the whole drug development life cycle.

Accountabilities/Responsibilities:

• You will join a department that plays a key role in the success of drug development at EMD Serono. As an expert in statistics, you will be responsible to consider, evaluate and propose the optimal analysis methodology and data presentation techniques.
• You will translate problems into mathematical forms and use state-of-the-art modelling techniques to provide solutions.
• You will direct and ensure the accuracy and timeliness of the vendor’s output. You will anticipate and communicate study level resource and quality issues that may impact deliverables or timelines and you will propose and implement solutions.
• You will support the development and implementation of departmental standards and process improvements to maximize global data integration and interpretability. In addition, you will be directly responsible for the statistical integrity, adequacy and accuracy of the clinical studies within the project.
• You will represent the Biostatistics department in all interactions linked to the project that will take place with the Health Authority.

Essential Skills & Capabilities:

• Previous experience in a similar position as a key Senior Statistician within a global development project ideally in Neurodegenerative diseases (Multiple Sclerosis mainly), Rheumatology / Immunology or Oncology will be helpful to progress rapidly in this position and to ensure that you successfully operate as a leading Statistician.
• This role will require strong communications and influencing skills and great adaptability, interacting with the global project team, leveraging internal and external resources to achieve high quality, timely and cost-effective study deliverables.

In addition the following will be required:

• MSc or PhD in statistics, biostatistics, mathematics or similar
• 8 years+ experience as a Senior Statistician in clinical trials (ideally applied to Neurodegenerative diseases -Multiple Sclerosis-, Rheumatology / Immunology and Oncology, but also in Endocrinology and Fertility).
• Experience in design and analysis of clinical programs and studies
• Experience gained or developed in a pharmaceutical, Biotech or CRO environment
• In depth knowledge of regulatory guidelines in pharmaceutical research
• Demonstrated project management skills
• Strategic approach towards drug development extending beyond the statistical aspects
• Demonstrated experience with statistical packages such as SAS, or R
• Excellent communication and collaboration skills in English (ability to communicate clearly and effectively in written reports, data presentations and meetings).

Scientist/Sr Scientist – Oncology Drug Discovery

Location: Cambridge, MA

Job Code 1218-TB

We are seeking an energetic and self-motivated PhD scientist to join a team of scientists working towards discovery of unique anti-cancer agents for the treatment of targeted patient populations. The candidate will be a highly creative cancer biologist with a strong desire to succeed at the highest level. This individual will lead drug discovery projects in a team environment and direct the activities of research associates under their supervision.

Principal Duties and Responsibilities

Design, execute and interpret cell based and in vivo pharmacology experiments to optimize compound selection and explore therapeutic potential of drug targets.

Lead drug discovery biology efforts to selection of lead candidate molecules and transition into clinical development

Design and develop cell and molecular assays to define mechanism of action for oncology therapies

Identify pharmacodynamic assays for utility in pre-clinical and clinical setting; define PK/PD/efficacy relationships and test patient selection strategies

Utilize literature and internal genomics data sets to design and test hypothesis for drug targets

Present and report research findings at internal meeting an external scientific conferences

Manage and direct the activities of a group of research associates

 Job Qualifications:

• Ph.D or in cell/molecular biology, pharmacology or genetics with 3-5 years industry experience in oncology drug discovery/translational research
• Strong background in Cancer Biology, experience with antibody based therapies desired
• Experience with state of the art molecular biology methods and assays essential to drive drug discovery projects.
• Experience using in vivo oncology models for drug discovery and translational research.
• Proven track record for striving for high level of innovation and scientific excellence.
• Excellent management, training and education skills.
• Excellent interpersonal skills with a proven record of empowering world class science and energizing teams.
• Flexibility to accommodate to rapidly changing priorities and deadlines.
• Ability to work in a team-based environment
• Excellent oral and written communication skills

H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs

Interested candidates may forward a CV to h3_career@h3biomedicine.com

www.h3biomedicine.com

Senior/Principal Scientist – Bioinformatics

Job Code:1211-BI

Location :Cambridge, MA

General Summary:

H3 Biomedicine Inc. is a privately held, uniquely structured oncology discovery enterprise. H3 aims to produce novel cancer therapeutics using a Patient to Patient Strategy aiming to exploit changes in the cancer genome of patients.  Our  highly integrated multidisciplinary scientific teams apply their expertise in cancer genomics, target validation, assay development, compound production and compound optimization, to advance a selected target through focused proof of concept  milestones that ultimately demonstrate cancer dependency to the target in genetically defined cancer patient populations.

Bioinformatics is a fundamentally important core discipline and integral part of H3 Biomedicine. The team plays key role in leveraging internal and external cancer genomics and pharmacogenomics data for developing new breakthrough oncology drugs. The team is responsible for the development and maintenance of bioinformatics core infrastructure and analytical pipelines. In addition, the team is also responsible for the development of databases and innovative solutions for data, information management and integration, and information intelligence.

We are seeking highly motivated individuals with diverse backgrounds to join our bioinformatics team. The ideal candidate should have solid scientific training in one of the relevant disciplines and is delivery oriented with a focus on real world impact. The candidate should also be a quick learner, extremely flexible and able to adapt to needs and new scientific advancements.

Principal Duties and Responsibilities:

• Contribute to the identification and validation of novel cancer targets leveraging public and proprietary cancer genomics and genetics data and work closely with target validation team.
• Represent bioinformatics discipline in drug discovery project team to provide broad range of support to ensure best use of all relevant data impacting project decisions:
  • Proactively identify opportunities and proposal informatics solutions.
  • Independently carry out informatics analysis.
  • Summarize and present scientific results with clear conclusions and recommendations.
  • Contribute to the development of innovative data management/integration and information intelligence solutions:
    • Act as bridge between end users and developers to clarify and define system requirement.
    • Provide bioinformatics support to ensure data quality and usability.
    • Conduct data mining to extract maximal value out of information system.
    • Maintain expertise in state-of-the-art bioinformatics methods.
    • Communication:
      • Proactively communicate to supervisor and key stakeholders of activities and status.
      • Generate patent, technical documents, external publications and presentation.
      • Must be able to multi-task.

Principal Duties and Responsibilities of principal scientist– in addition to senior scientist:

• Provide leadership within the bioinformatics team and act as scientific resources for team members.
• Propose and manage external collaboration opportunities.
• Manage projects and initiatives within the team or cross disciplines.
• Identify, evaluate, recommend and drive the adoption of new capabilities.

Job qualifications:

• Ph.D in bioinformatics, computational biology, computer science, or related field with 2+ years of working experience in related field.
• Proficiency in large volume data analysis including:
  • Experience with diverse types of genomics data such as gene expression profiling, copy number profiling, RNAi screening, next-generation sequencing, and expert user of genomics data analysis tools/packages such as Bioconductor, GenePattern, or equivalent.
  • Solid understanding of statistical analysis principles and expert user of one of the statistical data analysis tools/packages, such as R, matlab, or equivalent.
  • Experience and training in the area of machine learning.
  • Ability to independently manipulate large datasets in Unix/Linux environment.
  • Proficiency in common bioinformatics databases and tools, can independently design and perform diverse bioinformatics tasks.
  • Experience with data visualization as an effective way of presenting and communicating results.
  • Strong computer skills including basic database and software development training/experience.
  • Ability to understand real world problems thoroughly and propose fit-for-purpose solutions to the right problem.
    • Excellent interpersonal skills with a proven record of interacting with biologists effectively.
    • Must be a team player.
    • Excellent written and verbal communication skills.

H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs

Interested candidates may forward a CV to h3_career@h3biomedicine.com

www.h3biomedicine.com

Company Overview: Our client is a life sciences consulting firm specializing in accelerating the clinical product development process for pharmaceutical, medical device, and other life sciences organizations through sound strategy, efficient operations and compliant quality systems. 

Job Overview:  We are working with a leading consulting firm to identify individuals to join their team to work on projects focused on regulatory strategies relating to clinical and commercial development. Individuals hired would work on a variety of projects for therapeutic, diagnostic and medical device companies to advance their technologies through the clinical and into commercial.

Job Requirements:

• Minimum of 2 years' experience working in the biotech, pharmaceutical or medical device industry
• BS or MS in Biology, Chemistry, Engineering or a related field.
• Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to therapeutic and medical device regulations.
• Excellent organizational skills, demonstrated ability to prioritize multiple projects.
• Excellent written and verbal communication skills.
• Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels.
• Ability to effectively interpret guidance and provide recommendation to key stakeholders.
• RAC certification is a plus

Manager, Compound Management

Job Code:1217 TCP

Location: Cambridge, MA

H3 Biomedicine is looking for a highly motivated and enthusiastic Compound Management associate to support H3’s effort to discover unique anti-cancer compounds for the treatment of targeted patient populations. In this position, the candidate will help establish a state-of-the art compound management system for the storage of newly synthesized compounds and for the rapid distribution of requested compounds. This role requires excellent organization and communication skills, as well as routine operation of laboratory robotics and interfacing with relevant software tools.

Principal Duties and Responsibilities:

• Help implement new solutions to address the Compound Management needs of H3
• Perform Compound Management tasks like sample preparation, fulfilling ad-hoc requests at times of high demand, sample reformatting (historical & purchased samples)
• Closely interact with the automation, screening, analytical chemistry and IT groups to ensure an efficiently run operation
• Interact with H3 scientists to anticipate compound needs

 Qualifications:

• BS in chemical or biological sciences or engineering with 3+ years of experience in compound management
• Familiarity with common laboratory operations, working knowledge of operation of liquid handling systems (e.g. Tecan) and other automated plate processors is preferred
• Familiarity with analytical and/or purification chemistry techniques is a plus
• Working knowledge of Microsoft Office applications required; Visual Basic, SQL, or familiarity with databases is a plus
• Excellent time management, training and education skills
• Flexibility to accommodate to rapidly changing priorities and deadlines
• Ability to work in a team-based environment
• Excellent oral and written communication skills

H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs

Interested candidates may forward a CV to h3_career@h3biomedicine.com

www.h3biomedicine.com

Manager, Compound Management

Job Code:1217 TCP

Location: Cambridge, MA

H3 Biomedicine is looking for a highly motivated and enthusiastic Compound Management associate to support H3’s effort to discover unique anti-cancer compounds for the treatment of targeted patient populations. In this position, the candidate will help establish a state-of-the art compound management system for the storage of newly synthesized compounds and for the rapid distribution of requested compounds. This role requires excellent organization and communication skills, as well as routine operation of laboratory robotics and interfacing with relevant software tools.

Principal Duties and Responsibilities:

• Help implement new solutions to address the Compound Management needs of H3
• Perform Compound Management tasks like sample preparation, fulfilling ad-hoc requests at times of high demand, sample reformatting (historical & purchased samples)
• Closely interact with the automation, screening, analytical chemistry and IT groups to ensure an efficiently run operation
• Interact with H3 scientists to anticipate compound needs

 Qualifications:

• BS in chemical or biological sciences or engineering with 3+ years of experience in compound management
• Familiarity with common laboratory operations, working knowledge of operation of liquid handling systems (e.g. Tecan) and other automated plate processors is preferred
• Familiarity with analytical and/or purification chemistry techniques is a plus
• Working knowledge of Microsoft Office applications required; Visual Basic, SQL, or familiarity with databases is a plus
• Excellent time management, training and education skills
• Flexibility to accommodate to rapidly changing priorities and deadlines
• Ability to work in a team-based environment
• Excellent oral and written communication skills

H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs

Interested candidates may forward a CV to h3_career@h3biomedicine.com

www.h3biomedicine.com

Job Description:

The PV Scientist assists and supports the ongoing aggregate review and analysis of product safety data to support the product life cycle for assigned molecules, both pre and post-marketing. Such tasks include preparation and authoring of aggregate safety data including signaling reports, PSURs (Periodic Safety Update Reports), Annual Safety Reports, and reports to support internal/external data safety monitoring boards. The PV Scientist will also support Risk Evaluation and Mitigation Strategy (REMS) plans, Pharmacovigilance Plans, EU Risk Management Plans, product recalls, and other safety surveillance activities. The PV Scientist will author and assist in signal evaluations and the management of responses to regulatory agencies related to the assigned product.

Qualifications:

Able to interact collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues for partnered

Develops and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.

Excellent written and verbal communication skills. Demonstrated presentation skills.

Extensive medical writing, editing, and source document review.

Clinical judgment, ability to interpret case information

Knowledge of drug development process.

Basic knowledge of applicable clinical trial safety regulations and postmarketing regulations.

Demonstrated ability to independently manage complex projects with multidisciplinary teams

Medical writing, editing, and source document review.

Clinical judgment, ability to interpret case information

Basic medical literature search skills.

Strong organizational skills, including the ability to prioritize independently with minimal supervision.

Ability to adapt to a rapidly changing environment

Proven ability to evaluate. clinical and epidemiologic data

Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).

Knowledge of common safety database systems

Minimum 3 years relevant experience (including industry experience) with familiarity with industry principles of drug safety, drug development, regulatory, pharmacology, and pharmacoepidemiology.

 Education: Academic degree in biological or natural science or health care discipline (e.g. PhD, MPH, NP, Pharm D, MSc).