Principal Scientist, Analytical Development

Job Summary

Reporting to the Director of Analytical Development, the Principal Scientist will be responsible for development, implementation and qualification of cell-based assays (potency, immunogenicity, etc.). The successful candidate will lead cell-based analytical technology transfers from Analytical Development to internal and external partners and will author technical sections of regulatory briefing packages and submissions. Leading and mentoring a small team of scientists is a core component of this role.

Responsibilities

• Lead a team responsible for the development, optimization, qualification, and technology transfer of cell-based assays for drug substances and drug products across the CRISPR portfolio, including potency assays for ex vivo and in vivo programs, as well as the qualification and maintenance of the associated cell lines.
• Apply flow cytometry expertise to support cell-based testing, and oversee the trending of potency data and the establishment of specifications for lot release and stability studies.
• Provide technical and operational oversight to contract labs supporting cell-based potency tests for multiple products across the portfolio.
• Maintain current knowledge of applicable regulatory guidance, including FDA and EMA guidance documents, CFR, ICH, USP, Ph. Eur., and JP.
• Mentor and develop junior scientists, supporting their growth into roles of increasing responsibility.

Minimum Qualifications

• Ph.D. in Biology, Chemistry, Chemical Engineering or related discipline with 8+ years of relevant post-doctoral industry experience, or a B.S./M.S. with 15+ years of relevant industry experience.
• Hands-on proficiency in mammalian cell culture, flow cytometry, droplet digital PCR (ddPCR), Sanger sequencing, and amplicon next-generation sequencing (NGS).
• Skilled in data analysis and statistical software (e.g., JMP, GraphPad Prism, QuBAS, SoftMax Pro, FlowJo, MACSQuantify), including parallel line analysis for the interpretation of potency data.
• Experience with both ex vivo and in vivo cell and gene therapy platforms.
• Solid understanding of lipid nanoparticle (LNP) delivery systems for in vivo applications.
• Experience leading assay lifecycle management for cell and gene therapy products.
• Keep up to date with regulatory guidelines from FDA and EMA and guidance documents (CFR, ICH, USP, and Ph. Eur.).

Preferred Qualifications

• Ability to mentor a team of scientists into increasing responsibility.
• Experience authoring regulatory submission documents.
• Experience with leading analytical method transfer and supporting process technology transfer.
• Proficiency in risk assessments supporting comparability, process and method changes, and the definition of drug product critical quality attributes (CQAs).
• Demonstrated ability to collaborate effectively within cross-functional teams.

Competencies

• Collaborative - Openness, One Team
• Undaunted - Fearless, Can-do attitude
• Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit - Proactive. Ownership mindset.

Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.

Pay and benefits

Principal Scientist, Analytical Development: Base pay range of $160,000 to $180,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.