Senior Scientist: Bioassay Development & QC (GMP)

Biopharma Careers; Waltham (MA); On-site; USD 101,000 - 145,000; Full time

Job summary

Sanofi is seeking a Senior Scientist to lead Bioassay Development and Quality Control in our Waltham, MA lab. You will advance potency method development, qualification, QC testing, and transfer activities for viral and non-viral gene therapies in a GMP setting.

You will serve as SME for biological potency assays, drive method development and validation, and support clinical programs with timely, well-documented analytical results within a matrixed global organization.

Qualifications

• PhD in Biological Sciences or related field; MS may be considered.
• 2+ years in GMP environment required; 4+ years in industry with gene therapy preferred.
• Bioassay development experience; QC release and stability assay experience.

Responsibilities

• Lead early-stage GMP release testing and maintain GMP compliance.
• Serve as SME for biological potency assays for viral and non-viral products.
• Develop, qualify, validate, and transfer analytical methods.
• Provide quality system coaching and support to the team.
• Deliver analytical results with proper documentation to support development.

Skills

Bioassay development

QC release and stability assays

Analytical method transfer

Analytical leadership

Education

PhD in Biological Sciences

MS considered

Tools

BioVia

DOE approaches

Job description

Sanofi is seeking a Senior Scientist to lead Bioassay Development and Quality Control in our Waltham, MA lab. You will advance potency method development, qualification, QC testing, and transfer activities for viral and non-viral gene therapies in a GMP setting.

You will serve as SME for biological potency assays, drive method development and validation, and support clinical programs with timely, well-documented analytical results within a matrixed global organization.