Job Summary

Reporting to the Director of Analytical Development, theSenior Scientistwillberesponsiblefordevelopment, implementation, and qualification of cell-basedassays(potency, immunogenicity, etc.).The candidate will leadcell-basedanalytical technology transfers from Analytical Development to collaborators within and outside CRISPR Therapeutics.They will also authorsections of regulatory briefing packages or submissions related to technicalrole.

Responsibilities

• Lead a team responsible for the development, optimization, and 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 the team in qualifying andmaintainingcell lines for various potency assays.

• Expertise in flow cytometry-based assays required to support various cell-based testing. Lead team responsible for trending potency data andestablishingspecifications 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 awareness of applicable regulatory guidelines inareaof expertise, including but not limited to guidelines from ICH, USP, EP, and JP.

Minimum Qualifications

• Ph.D. in Biology, Chemistry, ChemicalEngineeringor related discipline with4 -8+years ofpost-PhDrelevant industry experience, or non-PhD with 12-15 years of relevant experience.

• Proficient in mammalian cell culture, flow cytometry, droplet digital PCR, sanger sequencing, and amplicon next generation sequencing platforms.

• Proficient in statisticalanalysessoftware, including JMP,GraphPAD,Qubas,Softmax,FlowJo,MACSQuantify.

• Proficient in parallel line analysis for interpretation of potency data.

• Expertiseapplied 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.

Preferred Qualifications

• Ability to mentor a team of scientistsinto increasingresponsibility.

• Experience with authoring regulatory submission documents.

• Experience with leading analytical method transfer and supporting process technology transfer.

• Awareness of regulatory guidelines in FDA and EMA guidance documents, CFR, ICH, USP, and Ph. Eur.

• Proficient in risk assessments to support comparability assessments, process and method changes, andestablishdrug product critical quality attributes.

• Ability to work in cross functional teams supporting product development and tech transfers.

Competencies

• Collaborative 6 Openness, One Team

• Undaunted 6 Fearless, Can-do attitude

• Results Orientation 6 Delivering progress toward our mission.Senseof urgency in solving problems.

• Entrepreneurial Spirit 6 Proactive. Ownership mindset.

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

Senior Scientist, Analytical Development: Base pay range of $140,000 to $155,000+ bonus, equity and benefits

The range provided is CRISPR Therapeutics9 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.