Senior Scientist – Bioassay Development & QC (Gene Therapy)

Sanofi; Waltham, Northern (MA, KY); Hybrid; USD 101,000 - 145,000; Full time

Benefits offered by this job

14 weeks parental leave

Health insurance

Competitive compensation

Job summary

Sanofi in Waltham, MA is seeking a Senior Scientist to advance potency method development and QC testing for gene therapy products in a fast-paced GMP environment. You will perform hands-on bioassay development, qualification, validation and CRO transfer, writing SOPs and reports, and presenting results to the team.

The ideal candidate has a PhD in Biological Sciences (MS considered), 4+ years in industry with GMP experience, and strong knowledge of potency assays, flow cytometry, and analytical

Qualifications

• PhD in Biological Sciences or related field required; MS considered.
• 4+ years of GMP experience in a related role.
• Experience with gene therapy potency assays and analytical method transfer.

Responsibilities

• Early-stage GMP release testing and maintaining GMP-compliant environment.
• Serve as SME for biological potency assays for viral and non-viral products.
• Development, qualification, validation and transfer of analytical methods.

Skills

Bioassay development

GMP

QC testing

Flow cytometry

DOE

Data analysis

Regulatory guidance knowledge

Education

PhD in Biological Sciences

MS considered

Tools

BioVia

Job description

Sanofi in Waltham, MA is seeking a Senior Scientist to advance potency method development and QC testing for gene therapy products in a fast-paced GMP environment. You will perform hands-on bioassay development, qualification, validation and CRO transfer, writing SOPs and reports, and presenting results to the team.

The ideal candidate has a PhD in Biological Sciences (MS considered), 4+ years in industry with GMP experience, and strong knowledge of potency assays, flow cytometry, and analytical