Senior Research Associate – Biologics Drug Product Development

Job Responsibilities:

The senior research associate (SRA) will be part of Global Drug Product Development and Manufacturing, supporting biologic drug product formulation and process development. The SRA will play a critical role in supporting laboratory-based studies working on different facets of drug product formulation and process development, across multiple modalities including monoclonal antibodies (mAb), multi-specific antibodies, therapeutic enzymes, and fusion proteins. Formulation work would include both liquid and lyophilized formulation development, and process characterization from early phase 1 through phase 3 drug product development.

Key Responsibilities:

• Execution of formulation, process development and stability studies for both liquid and lyophilized products.
• Work with internal and external partners to efficiently and comprehensively address formulation, stability and compatibility aspects using established assays, across a variety of technological platforms and disciplines.
• Planning, prioritization and initiation of concurrent experimental procedures for multiple programs to ensure their timely completion is essential.
• Take ownership of assigned studies to ensure timely completion.
• Support laboratory technology development and ownership of equipment.
• Develop subject matter expertise in process characterization.
• Support implementation and development of new ways of working, including innovative research approaches and digital tool development.
• Maintain a strong work ethic and good documentation practices including electronic laboratory notebook maintenance and writing of technical reports and procedures.
• Analyze, compile and present results to internal and cross functional teams comprised of members from multiple groups and stakeholders.
• Support technology transfer activities to clinical and commercial manufacturing sites.

Basic Qualifications:

• Master’s degree in biochemistry, pharmaceutical science, chemical or protein engineering, or related field -OR- bachelor’s degree with minimum 2 years of relevant industry experience
• Knowledge of analytical and biophysical characterization techniques such as HPLC, CE-SDS, DSC, CD, DLS, and fluorescence microscopy
• Strong communication and collaboration skills
• Ability to learn new skills, be flexible and adaptable to work in a fast-paced team environment.
• Comfortable working in a matrix team environment

Preferred Qualifications:

• Hands-on experience with common analytic technologies, such as SEC, SDS-PAGE, DLS, DSC, IEF/cIEF, spectroscopy and calorimetry
• Experienced in formulation optimization, stability study, product process development and control for each unit operation, including mixing, filtration, fill finish, and technology transfer.
• Previous experience in biopharmaceutics manufacturing, lyophilization and process simulation is preferred. Working knowledge in overall biopharmaceutical development process for injectable drug products of biologic drug candidates.
• Basic understanding of statistical data analysis, good written and verbal communication skills in data presentation and authoring study reports and regulatory filing documents.

Applicants must have work authorization in the U.S.

Relocation support is not available for this role.

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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