Senior Scientist, Analytical Development
CRISPR Therapeutics
August 11, 2026
On-site
Boston, MA
Operations
Job Summary
Reporting to the Director of Analytical Development, the Senior Scientist is responsible for development, implementation, and qualification of cell-based assays (potency, immunogenicity, etc.). Leads cell-based analytical technology transfers from Analytical Development to internal/external collaborators and authors sections of regulatory briefing packages or submissions related to the technical role.
Responsibilities
- Lead a team 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; qualify and maintain cell lines for potency assays.
- Flow cytometry-based assay expertise; trend potency data 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.
- Maintain awareness of applicable regulatory guidelines (e.g., ICH, USP, EP, JP).
Minimum Qualifications
- Ph.D. in Biology, Chemistry, Chemical Engineering or related field with 4–8+ years post-PhD industry experience, or non-PhD with 12–15 years relevant experience.
- Proficient in mammalian cell culture, flow cytometry, droplet digital PCR, Sanger sequencing, and amplicon next generation sequencing.
- Proficient in statistical analysis software (JMP, GraphPad, Qubas, Softmax, FlowJo, MACSQuantify).
- Proficient in parallel line analysis for potency data interpretation.
- Expertise in ex-vivo and in-vivo cell and gene therapy platforms.
- Experience leading assay lifecycle management for Cell and Gene Therapy products (strongly desired).
Preferred Qualifications
- Ability to mentor scientists.
- Experience authoring regulatory submission documents.
- Experience leading analytical method and supporting process technology transfers.
- Awareness of FDA/EMA guidance, CFR, ICH, USP, Ph. Eur.
- Proficient in risk assessments for comparability, process/method changes, and defining drug product critical quality attributes.
- Ability to work in cross-functional teams supporting product development and tech transfers.
Reporting to the Director of Analytical Development, the Senior Scientist is responsible for development, implementation, and qualification of cell-based assays (potency, immunogenicity, etc.). Leads cell-based analytical technology transfers from Analytical Development to internal/external collaborators and authors sections of regulatory briefing packages or submissions related to the technical role.
Responsibilities
- Lead a team 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; qualify and maintain cell lines for potency assays.
- Flow cytometry-based assay expertise; trend potency data 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.
- Maintain awareness of applicable regulatory guidelines (e.g., ICH, USP, EP, JP).
Minimum Qualifications
- Ph.D. in Biology, Chemistry, Chemical Engineering or related field with 4–8+ years post-PhD industry experience, or non-PhD with 12–15 years relevant experience.
- Proficient in mammalian cell culture, flow cytometry, droplet digital PCR, Sanger sequencing, and amplicon next generation sequencing.
- Proficient in statistical analysis software (JMP, GraphPad, Qubas, Softmax, FlowJo, MACSQuantify).
- Proficient in parallel line analysis for potency data interpretation.
- Expertise in ex-vivo and in-vivo cell and gene therapy platforms.
- Experience leading assay lifecycle management for Cell and Gene Therapy products (strongly desired).
Preferred Qualifications
- Ability to mentor scientists.
- Experience authoring regulatory submission documents.
- Experience leading analytical method and supporting process technology transfers.
- Awareness of FDA/EMA guidance, CFR, ICH, USP, Ph. Eur.
- Proficient in risk assessments for comparability, process/method changes, and defining drug product critical quality attributes.
- Ability to work in cross-functional teams supporting product development and tech transfers.