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Associate Scientist, Framingham, MA

Expired Job

Sanofi Framingham , MA 01702

Posted 2 months ago

The Associate 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:

Associate 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 Bio-process 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:

Bachelors OR Masters degree (Chemical, Biochemical or Biologic discipline) from a reputable University AND 4+ years of relevant downstream processing experience

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

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.

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

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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Associate Scientist, Framingham, MA

Expired Job

Sanofi