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A Range of Possibilities

Senior Scientist, Biologics Product Development and Manufacturing

date posted 04/13/2021
contract type Full time
job id R2594542
location Massachusetts; Framingham, Massachusetts

Position Overview:

The incumbent will join a dynamic multi-disciplinary multi-modality drug product development team, with responsibilities that span from formulation development to fill finish of clinical, commercial and life-cycle stage assets within the Biologics Drug Product Development and Manufacturing which is part of the Global CMC Development organization.

Key Responsibilities:

The Senior Scientist role is responsible for drug product development of injectable dosage forms (liquid, lyophilized or frozen drug product) for clinical and commercial use and conducting process optimization and scale-up studies to support technology transfer to manufacturing sites which includes:

  • Develop experimental plans and execute studies to assess physicochemical stability of biologic drug candidates.

  • Develop plans as well as assist in process development studies for routine manufacturing unit operations for injectable dosage forms (e.g. freeze-thaw, mixing, filtration, filling, lyophilization etc.).

  • Work closely and independently with counterparts from other functional areas to deliver on CMC milestones while adhering to broad project timelines.

  • Generate, document and compile data for team and senior management discussions, development reports and regulatory filings.

  • Mentor junior staff as required

Basic Qualifications:

  • PhD in biotechnology, pharmaceutics, chemical engineering or related discipline with a minimum of 4 years of relevant experience or a Master’s degree with a 8 or Bachelor’s degree with 10 years of relevant experience.

  • A thorough understanding of protein structure, chemistry and stability attributes.

  • An understanding of fundamental biopharmaceutical principles for the development of injectable drug products of biologic drug candidates.

  • Hands-on experience with bioanalytical instrumentation, such as SEC, SDS-PAGE, IEF/cIEF, spectroscopy and calorimetry.

  • Experience with biophysical characterization, thermodynamics and mechanistic understanding of protein degradation, protein-protein, and protein-excipient interactions.

  • Basic understanding of statistical data analysis, written and verbal communication skills.

Preferred Qualifications:

  • At least two years of relevant drug product lead/technical management experience.

  • Strong understanding of designing studies for protein formulation development, optimization, and robustness of liquid, frozen, and lyophilized products.

  • Practical experience with developing peptide and/or antibody-based drug products including formulation and process selection; experience with high protein concentration formulations and pre-filled syringe-based products.

  • Ability to effectively lead and participate in technical team discussions.

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.

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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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