Senior Scientist, Analytical Development

Company Overview

Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene‑based medicines for serious human diseases. The company evolved from a pioneering research‑stage organization to an industry leader, marked by the approval of CASGEVY® (exagamglogene autotemcel, also known as eXa‑cel), the world’s first CRISPR‑based therapy for sickle cell disease and transfusion‑dependent beta thalassemia. CRISPR Therapeutics advances a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine, and rare diseases.

The company expands its leadership in gene editing through the development of SyNTase™ editing, a novel, proprietary gene‑editing platform for precise, efficient, scalable correction. Strategic collaborations with biopharmaceutical partners, including Vertex Pharmaceuticals, accelerate the impact of these technologies. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations in Boston, Massachusetts and San Francisco, California.

Reporting to the Director of Analytical Development, the Senior Scientist will develop, implement, and qualify cell‑based assays (potency, immunogenicity, etc.). The candidate will lead cell‑based analytical technology transfers from Analytical Development to collaborators within and outside CRISPR Therapeutics, and will author sections of regulatory briefing packages or submissions related to the technical role.

• Lead a team responsible for the 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 the team in qualifying and maintaining cell lines for various potency assays.
• Use flow cytometry‑based assays to support diverse cell‑based testing.
• Lead the team responsible for trending potency data and establishing 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 awareness of applicable regulatory guidelines in the area of expertise, including but not limited to guidelines from ICH, USP, EP, and JP.

• Ph.D. in Biology, Chemistry, Chemical Engineering, or a related discipline with 4–8+ years of post‑Ph.D. relevant industry experience, or non‑Ph.D. 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 statistical analysis software, including JMP, Graph Pad, QUBAS, Softmax, Flow Jo, MACS Quantify.
• Proficient in parallel line analysis for interpretation of potency data and 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.

• Ability to mentor a team of scientists into increasing responsibility.
• Experience with authoring regulatory submission documents.
• Experience with leading analytical method transfer and supporting process technology transfer.
• Awareness of regulatory guidance in FDA and EMA, CFR, ICH, USP, and Ph. Eur.
• Proficiency in risk assessments to support comparability assessments, process and method changes, and establishing drug product critical quality attributes.
• Ability to work in cross‑functional teams supporting product development and tech transfers.

• 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.

Base pay range of $140,000 to $155,000 plus 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.

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