Job Title: Senior Scientist Bioassay Development and Quality Control

• Location: Waltham, MA

About the Job:

Opportunity to join a fast-paced Gene Therapy bioanalytical team focusing on potency method development, qualification, QC testing and CRO transfer in a compliant GMP environment. This position will improve analytical capacity for the potency team, allowing more programs to progress efficiently through early phase development.  The successful candidate will be responsible for method development for multiple viral and non-viral gene therapies through hands-on work including method development and optimization, SOP and report writing and providing group presentations.  This is a great opportunity for an energetic and dedicated team player willing to do what it takes to support our goal of releasing critical medicines to patients.   

Main Responsibilities:

• Responsible for early-stage GMP release testing and maintaining a GMP compliant environment.

• Serve as a subject matter expert (SME) for biological potency assays for viral and non-viral products, define the best scientific approaches and analysis methods for quantitative bioassays

• Development, qualification and validation and transfer of analytical methods

• Master Sanofi quality systems providing expertise and coaching to team members

• Perform analytical support testing, ensuring timely completion and delivery of analytical results with appropriate documentation to support product development during clinical phases

• Participate in analytical leadership teams for viral and non-viral programs

• Take an active role in Lab maintenance, organization, GMP and safety compliance

• Ensure compliant use of electronic notebooks

• Work in a matrixed environment and interact productively with associates, scientists and management at various levels, both locally and internationally

About You:

Education:

• PhD in Biological Sciences or related fields, Master's Degree (MS) will be considered.

• 2+ years of experience in a GMP environment (required)

• 4+ years of relevant industry experience, including gene therapy (preferred)

Experience & Technical Skills:

• Bioassay development experience

• Experience in performing QC release and stability assays

• Aptitude to manage multiple types of quality events including deviations, change controls, lab investigations

Preferred Qualifications:

• Experience with flow cytometry, FRET-assays, effector function assays, reporter cell lines, PCR analysis and/or ELISA endpoints, DOE approaches where appropriate

• Experience automating cell-based assays

• Comprehensive knowledge of gene therapy analytics including potency and impurity paradigms, knowledge of gene therapy regulatory guidance

• Experience performing analytical support for structure/function and in-process studies

• Knowledge of various approaches to data analysis, strong understanding of relative potency assay analysis including software and regulatory expectations

• Experience in technology transfer to other sites 

• Experience with BioVia products

Why choose us?

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

• Discover endless opportunities through working with a talented and dedicated team in an integrated environment.  Grow your talent and drive your career in gene therapy. 

• 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.​

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

The salary range for this position is:

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