Senior Scientist, Analytical Development
CRISPR Therapeutics
September 01, 2026
On-site
Boston, MA
Operations
Reporting to the Director of Analytical Development, the Senior Scientist will develop, implement, and qualify cell-based assays (e.g., potency, immunogenicity), lead cell-based analytical technology transfers, and author technical sections of regulatory briefing packages/submissions.
Responsibilities:
- Lead team developing, optimizing, transferring, and qualifying cell-based assays for Drug Products and Drug Substances across the CRISPR portfolio (including potency assays for ex-vivo and in-vivo programs); qualify/maintain cell lines.
- Lead flow cytometry-based assays; trend potency data; establish specifications for lot release and stability studies.
- Provide technical/operational oversight to contract labs performing cell-based potency tests across multiple products.
- Stay current on relevant regulatory guidelines (e.g., ICH, USP, EP, JP).
Minimum Qualifications:
- Ph.D. in Biology/Chemistry/Chemical Engineering or related + 4–8+ years industry experience, or non-PhD + 12–15 years relevant experience.
- Proficient in mammalian cell culture, flow cytometry, droplet digital PCR, Sanger sequencing, and amplicon next-gen sequencing.
- Proficient in statistical software (e.g., JMP, GraphPAD, Qubas, Softmax, FlowJo, MACSQuantify).
- Proficient in parallel line analysis for potency interpretation.
- Expertise in ex-vivo and in-vivo cell and gene therapy platforms.
- Assay lifecycle management experience for Cell and Gene Therapy strongly desired.
Preferred Qualifications:
- Mentor scientists; author regulatory submissions; lead analytical/process method transfers; FDA/EMA/CFR/ICH/USP/Ph. Eur. awareness; risk assessment for comparability/changes/CQAs; cross-functional collaboration.
Compensation/Benefits (role-related): Base pay range $140,000–$155,000+ plus bonus, equity, and benefits. Due to lab-based work, roles are fully on-site.
Responsibilities:
- Lead team developing, optimizing, transferring, and qualifying cell-based assays for Drug Products and Drug Substances across the CRISPR portfolio (including potency assays for ex-vivo and in-vivo programs); qualify/maintain cell lines.
- Lead flow cytometry-based assays; trend potency data; establish specifications for lot release and stability studies.
- Provide technical/operational oversight to contract labs performing cell-based potency tests across multiple products.
- Stay current on relevant regulatory guidelines (e.g., ICH, USP, EP, JP).
Minimum Qualifications:
- Ph.D. in Biology/Chemistry/Chemical Engineering or related + 4–8+ years industry experience, or non-PhD + 12–15 years relevant experience.
- Proficient in mammalian cell culture, flow cytometry, droplet digital PCR, Sanger sequencing, and amplicon next-gen sequencing.
- Proficient in statistical software (e.g., JMP, GraphPAD, Qubas, Softmax, FlowJo, MACSQuantify).
- Proficient in parallel line analysis for potency interpretation.
- Expertise in ex-vivo and in-vivo cell and gene therapy platforms.
- Assay lifecycle management experience for Cell and Gene Therapy strongly desired.
Preferred Qualifications:
- Mentor scientists; author regulatory submissions; lead analytical/process method transfers; FDA/EMA/CFR/ICH/USP/Ph. Eur. awareness; risk assessment for comparability/changes/CQAs; cross-functional collaboration.
Compensation/Benefits (role-related): Base pay range $140,000–$155,000+ plus bonus, equity, and benefits. Due to lab-based work, roles are fully on-site.