Senior Bioassay Scientist – GMP QC & Development

Sanofi EU; Waltham (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Parental leave (14 weeks)

Wellness programs

Competitive compensation

Job summary

Sanofi is seeking a Senior Scientist in Waltham, MA to join a fast-paced bioanalytical team focused on potency method development, qualification, QC testing and technology transfer within GMP environment.

You will lead development and validation of analytical methods for viral and non-viral gene therapies, serve as SME for potency assays, and collaborate across functions to ensure timely delivery of data supporting early-phase programs.

Qualifications

• PhD in Biological Sciences or related field.
• 2+ years of GMP experience.
• 4+ years of industry experience, including gene therapy.
• Bioassay development experience.
• Experience with QC release and stability assays.

Responsibilities

• Lead early-stage GMP release testing and maintain GMP-compliant environment.
• Serve as SME for biological potency assays; define approaches and analysis methods for quantitative bioassays.
• Develop, qualify, validate and transfer analytical methods.
• Provide master Sanofi quality systems expertise and coaching to team members.
• Perform analytical support testing with timely results and documentation to support clinical development.

Skills

Bioassay development

QC release testing

Stability assays

GMP experience

Education

PhD in Biological Sciences

MS considered

Tools

BioVia

Job description

Sanofi is seeking a Senior Scientist in Waltham, MA to join a fast-paced bioanalytical team focused on potency method development, qualification, QC testing and technology transfer within GMP environment.

You will lead development and validation of analytical methods for viral and non-viral gene therapies, serve as SME for potency assays, and collaborate across functions to ensure timely delivery of data supporting early-phase programs.