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Sanofi Group Principal Research Associate, Drug Product Development in Waltham, Massachusetts

Department/Position Overview:

The Principal Research Associate will be a part of the multi-disciplinary and multi-modality Global Drug Product Development & Manufacturing group. The candidate will primarily support Biopharmaceutical Drug Product development projects for Cell Therapy (in support of the Genomic Medicine Unit). The incumbent will also have the opportunity to work on different facets of formulation and process development for modalities such as Lipid Nanoparticles (LNPs), gene therapy capsids (recombinant AAV capsids), and Protein/Enzyme therapeutics

Key Responsibilities:

This role will primarily be responsible for developing dosage forms for clinical and commercial use, including formulation development, drug product process development and scale-up, product characterization, technology transfer, and GMP manufacture. Specifically:

  • Design and execute formulation development and optimization studies for cell therapy 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

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

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

Basic Qualifications:

  • Master’s degree in biochemistry, chemical engineering, biomedical engineering or a related discipline with a minimum of 2 years of relevant experience, or Bachelors degree with minimum of 4 years of relevant experience

  • Knowledge of techniques commonly used to measure physical and chemical characteristics of cell populations such as flow cytometry and fluorescence microscopy

  • Experience with cell culture and aseptic technique

  • 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 formulation, manufacturing, and cryopreservation of cell and/or gene therapy drug products

  • Hands on experience with BD FACSLyric, NovoCyte or Attune flow cytometers

  • Understanding drug handling and administration requirements at clinical sites and developing drug products to enable convenient dose preparation

  • Experience supporting GMP cell therapy manufacturing

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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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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