Senior Scientist, Cell-Based Analytics & Tech Transfer

Crispr Therapeutics Inc in; Boston (MA); On-site; USD 140,000 - 155,000; Full time

Job summary

CRISPR Therapeutics, Inc. in Boston, MA, seeks a Senior Scientist in Analytical Development to drive development, implementation, and qualification of cell-based assays and to lead transfers to collaborators.

This role will author sections of regulatory briefing packages related to the technical function. The candidate will manage cross-functional teams, ensure alignment with ICH/USP/GMP guidelines, and participate in lifecycle management for Cell and Gene Therapy products.

Qualifications

• Ph.D. in Biology, Chemistry, Chemical Engineering or related discipline with 4-8+ years post-PhD industry experience, or non-PhD with 12-15 years of experience.
• Proficient in mammalian cell culture, flow cytometry, ddPCR, Sanger sequencing, and amplicon next generation sequencing platforms.
• Proficient in statistical analyses software, including JMP, GraphPAD, Qubas, Softmax, FlowJo, MACSQuantify.

Responsibilities

• Lead a team responsible for development, optimization, technology transfer and qualification of cell-based assays for Drug Products and Drug Substances across the CRISPR portfolio.
• Lead the team in qualifying and maintaining cell lines for potency assays.
• Expertise in flow cytometry-based assays to support cell-based testing and establish specifications for lot release and stability studies.
• Provide technical and operational oversight to contract labs supporting cell-based potency tests for multiple products.

Skills

Mammalian cell culture

Flow cytometry

ddPCR

Sanger sequencing

Amplicon sequencing

Parallel line analysis

Education

Ph.D. in Biology, Chemistry, Chemical Engineering or related discipline

Tools

JMP

GraphPad

Qubas

SoftMax

FlowJo

MACSQuantify

Job description

CRISPR Therapeutics, Inc. in Boston, MA, seeks a Senior Scientist in Analytical Development to drive development, implementation, and qualification of cell-based assays and to lead transfers to collaborators.

This role will author sections of regulatory briefing packages related to the technical function. The candidate will manage cross-functional teams, ensure alignment with ICH/USP/GMP guidelines, and participate in lifecycle management for Cell and Gene Therapy products.