Lead Cell-Based Assay Scientist, Analytical Development

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

Job summary

CRISPR Therapeutics in Boston, MA seeks a Senior Scientist in Analytical Development to lead development, implementation, and qualification of cell-based assays, driving technology transfers to collaborators and authoring sections of regulatory briefing packages related to technical roles.

The candidate will manage a team, ensure regulatory compliance, and oversee partnerships with contract labs while advancing a diverse gene therapy portfolio. On-site role with competitive compensation.

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 relevant 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.
• Proficient in parallel line analysis for interpretation of potency data.
• Expertise applied to both ex-vivo and in-vivo cell and gene therapy platforms.
• Experience in leading assay lifecycle management for Cell and Gene Therapy products is strongly desired.

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, including potency assays for ex-vivo and in-vivo programs.
• Lead team in qualifying and maintaining cell lines for various potency assays.
• Provide technical and operational oversight to contract labs supporting cell-based potency tests for multiple products across the portfolio.
• Maintain awareness of regulatory guidelines from ICH, USP, EP, and JP.

Skills

Mammalian cell culture

Flow cytometry

ddPCR

Sanger sequencing

amplicon NGS

Statistical analyses (JMP, GraphPad, Q

Education

Ph.D. in Biology/ Chemistry/ Chemical Engineering or related

Non-PhD with 12–15 years relevant experience

Tools

JMP

GraphPad

Qubas

SoftMax

FlowJo

MACSQuantify

Job description

CRISPR Therapeutics in Boston, MA seeks a Senior Scientist in Analytical Development to lead development, implementation, and qualification of cell-based assays, driving technology transfers to collaborators and authoring sections of regulatory briefing packages related to technical roles.

The candidate will manage a team, ensure regulatory compliance, and oversee partnerships with contract labs while advancing a diverse gene therapy portfolio. On-site role with competitive compensation.