Senior Scientist, GMU CMC Drug Product Development

Job Title: Senior Scientist, GMU CMC Drug Product Development

Location: Waltham, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

We are seeking for a highly motivated Senior Scientist to be a part of the multi-disciplinary and multi-modality Global Drug Product Development & Manufacturing group. The candidate will be a part of the Biologics Drug Product Development team in support of Gene Therapy programs in the Genomic Medicine Unit. The incumbent will have the opportunity to work on different facets of drug product formulation and process development for modalities such as Lipid Nanoparticles (LNPs) and Adeno-Associated Virus (AAV).

 We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Design and execute formulation development and optimization studies for gene therapy (viral and non-viral) drug candidates

• Develop plans and assist drug product process development and scale up studies for drug product manufacturing processes

• Design and conduct studies to assess physicochemical stability of different candidates

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

• Lead and participate in technical team discussions

• Supervise/mentor junior staff as required and provide technical leadership to the team

• Generate, analyze, and present study data and results for team and senior management discussions, author development reports and docus for regulatory filing

• Maintain a strong work ethic and good documentation practices including electronic laboratory notebook maintenance

• Generate, analyze, and present study data and results for team and senior management discussions, author development reports and documents for regulatory filing

About You

Basic Qualifications:

• Ph.D degree in biochemistry, pharmaceutical science, chemical engineering, biomedical engineering or a related discipline, or Master’s degree with minimum of 4 years, or Bachelor’s degree with minimum of 6 years of relevant laboratory experience

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

• Knowledge and experience in using analytical and biophysical characterization techniques such as DLS, fluorescence spectroscopy, HPLC, etc.

• Ability to multi-task and learn new skills and possess flexibility and adaptability that is needed in a fast-paced team environment

• Basic understanding of statistical data analysis. Excellent communication, teamwork and collaboration skills.

Advanced (or Preferred) Qualifications:

• Experience in gene therapy, particularly formulation and process development of lipid nanoparticles and viral capsids-based drug product is a significant plus

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.