Senior Scientist, Bioassay Development & QC (GMP)

Sanofi; Massachusetts; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Parental leave

Health benefits

Growth opportunities

Job summary

Sanofi is seeking a Senior Scientist for Bioassay Development and Quality Control in Waltham, MA. The role focuses on potency method development, qualification, QC testing and CRO transfer within a GMP framework.

You will develop and optimize bioassays across viral and non-viral gene therapies, write SOPs and reports, and present findings to the group. The position involves hands-on method development, collaborative work across teams, and contributing to the release testing and transfer

Qualifications

• PhD in Biological Sciences or related field; MS considered.
• 2+ years of GMP environment experience.
• 4+ years of industry experience including gene therapy (preferred).

Responsibilities

• Lead early-stage GMP release testing.
• Serve as SME for biological potency assays (viral and non-viral products).
• Develop, qualify, validate, and transfer analytical methods.
• Support quality systems with coaching to team members.
• Provide analytical support and timely results for product development in clinical phases.
• Participate in analytical leadership for viral and non-viral programs.
• Maintain GMP compliance and safety in the lab.
• Use electronic notebooks in compliant manner.

Skills

Bioassay development

GMP experience

Flow cytometry

DOE approaches

Education

PhD in Biological Sciences

MS considered

Tools

BioVia

Job description

Sanofi is seeking a Senior Scientist for Bioassay Development and Quality Control in Waltham, MA. The role focuses on potency method development, qualification, QC testing and CRO transfer within a GMP framework.

You will develop and optimize bioassays across viral and non-viral gene therapies, write SOPs and reports, and present findings to the group. The position involves hands-on method development, collaborative work across teams, and contributing to the release testing and transfer