Job Description:Job SummaryReporting to the Director of Analytical Development, the Senior Scientist will be responsible for development, implementation, and qualification of 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. They will also author sections of regulatory briefing packages or submissions related to technical role.
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.
Minimum 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.
- Experience in leading assay lifecycle management for Cell and Gene Therapy products is strongly desired.
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.
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 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.
