Sanofi Group Scientist, Framingham, MA in Framingham, Massachusetts

The Scientist position is part of Process Science in Manufacturing Science & Technology (MSAT) and is based at the biologics hub in Boston. Global MSAT function within Specialty Care Operations (SCO) assures robustness and economics of cell-culture based manufacturing process in support SCO products Life Cycle Management Strategy (LCM) by

Driving next generation LCM process development and support key SCO strategic initiatives

Leading Tech transfer, scale-up development and adaptation, control strategy implementation, process validation, comparability for SCO products introduction at Sanofi and external Industrial sites

Owning process control strategy of licensed products and providing technical assistance and partnership to commercial manufacturing and QC at Sanofi and external sites including change assessment, process monitoring, troubleshooting and continuous improvement for drug substance

MSAT-Process Science is the process owner of all industrial manufacturing processes, analytical methods and associated process control strategies for antibodies and antibody-like molecules expressed from mammalian systems.

POSITION OVERVIEW / KEY RESPONSIBILITIES:

Scientist will be a key contributor in the Process Science Downstream group responsible for advancing life cycle management (LCM) of Sanofi’s commercial portfolio. The successful candidate will utilize chromatography, membrane separation and filtration technologies to improve current commercial progress and develop 2nd generation process of monoclonal antibodies and recombinant proteins, with responsibilities spanning bench and pilot-scale process development & characterization activities, as well as support of technology transfer to manufacturing facilities. This individual will work in a team environment, collaborating with various colleagues in R&D, Manufacturing technical services, Quality and Regulatory organizations.

Specific responsibilities:

Work collaboratively within the Process Science team to design and execute experiments supporting process definition, optimization, characterization, scale-up, validation, and transfer activities.

Advise members of project teams in the design, execution and analysis of laboratory experimentation

Author and review development & characterization reports, as well as process validation and regulatory filing reports when needed

Actively communicate activities and progress by presenting at varied technical forums

Maintain full working knowledge of principles and theories, and advance our understanding and control in both current and the 2nd gen commercial processes

Keep abreast of novel platform technology, PAT tool, and industrial best practice, and evaluate their potential application across multiple programs within the organization when needed

Collaborate with Bioprocess Engineering & Data Analytics group to apply modeling tools to scale-up and scale-down manufacturing processes in support of lab to commercial scale development and validations studies

Work closely with manufacturing technical support teams to identify risks and map out opportunities for process improvements, Perform lab scale studies to support manufacturing deviations for root cause identification and CAPA implementation

Support LCM project or Tech Transfer teams for process design, process control strategy, process validation and facility fit for current and next generation processes

Supervise junior team members or lead small team as needed

Work is performed with minimal supervision and direction. Participates in determining objectives of assignment. Independently determines and develops approach to solution. Work is reviewed for soundness of judgment and overall adequacy and accuracy.

  • Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs

BASIC QUALIFICATIONS:

EDUCATION/EXPERIENCE:

BS (Chemical, Biochemical or Biologic discipline) and 8+ years of relevant downstream processing experience

OR

Master Degree in Engineering (Chemical, Biochemical or Biologic discipline)

AND 6+ years of professional experience with downstream processing experience.

OR

PhD (Engineering, Biology discipline) from a reputable University.

AND 0 - 2 years of relevant professional experience, OR experience on internships, co-ops, etc.

PREFERRED QUALIFICATIONS:

• Hands-on experience at Laboratory, pilot or manufacturing scale for biological products

• Strong skills in data analytics and modeling methods and relevant software

• Strong experience in one or more areas of process development, process transfer, process scale-up and validation activities

• Good knowledge of use of structured methodologies in the areas related to downstream process design, scale-down model, process control strategies, scale-up, validation and continuous process verification as applied to mammalian-expressed proteins

• Solid understanding GMP commercial biologic manufacturing operations

• Some experience of working in a team environment with other technical staff

• Excellent scientific background and presentations skills

• Highly motivated individual with the ability to work independently as well as on a cross-functional and cross-site teams

KEY ATTRIBUTES:

Strives for results

sets ambitious tangible and measurable targets ; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets

Cooperates transversely

Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization

Commit to customers

Shares relevant information openly and seeks appropriate input from others outside of the direct team; develops and maintains effective cross-functional working relationships and partnerships; responds positively and constructively to requests for support from across the organization

Act for Change

Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes

Terms of employment:

Scientist is a technical individual contributor with no direct reports. The ideal candidate must be able to lead project teams independently. Standard business hours apply and routine travel is not expected.

What makes this position unique?

Global MSAT - Process Science focuses upon lab support, continuous improvement of the commercial process and the development of second generation process. It is unique to those individuals who seek involvement in GMP manufacturing with a focus on lab science.

Benefits of working in this role:

Cross-functional team leadership provides visibility and exposure to multiple areas in the organization.

Sanofi actively encourages internal career development growth opportunities.

Work closely with the large pool of talent in industrial bioprocess.

Hone your process development knowledge and experience, while working closely with GMP manufacturing.

Location information:

This position will be based in Framingham MA.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#LI-SA #GD-SA

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life