Senior Scientist, Analytical Development

About the role

CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia.

Reporting to the Director of Analytical Development, the Senior Scientist will be responsible for development, implementation, and qualification of cell-based assays (potency, immunogenicity, etc.).

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 and maintaining cell 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 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 area of expertise, including but not limited to guidelines from ICH, USP, EP, and JP.

Qualifications

Ph.D. in Biology, Chemistry, Chemical Engineering or related discipline with 4 -8+ years of post-PhD relevant 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 statistical analyses software, including JMP, GraphPAD, Qubas, Softmax, FlowJo, MACSQuantify.

Proficient in parallel line analysis for interpretation of potency data.

Expertise applied to both ex-vivo and in-vivo cell and gene therapy platforms.

Preferred Qualifications

• 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 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, and establish drug product critical quality attributes.
• Ability to work in cross functional teams supporting product development and tech transfers.

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.

Pay

Base pay range of $140,000 to $155,000+ bonus, equity and benefits. The range provided is CRISPR Therapeutics’ reasonable estimate of the base compensation for this role.

Schedule

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