Senior Scientist, Analytical Development
We are seeking a Senior Scientist to join an exciting, fast-growing and well-financed company to develop novel gene editing therapies for serious diseases. The successful candidate will join the Technical Operations (Tech Ops) group at Crispr Therapeutics, focusing on development of analytical methods for ex vivo genetically modified cells to support the development of gene editing programs. This candidate will be responsible for overseeing critical lot release and characterization assay development and external transfer, as well as managing multiple projects and personnel. The ideal candidate has broad analytical method development experience in the areas of cell-based potency assay development and characterization of cell and gene therapy products.
- Lead the development of quantitative assays for gene editing and cell-based assays measuring transgene expression and function (potency assays).
- Lead the development of data sets supporting product specification and qualification and/or validation of assays at CMOs and GMP test labs
- Work independently and provide leadership in collaboration with colleagues across disciplines from early research to Quality and Regulatory teams in support of project goals and timelines
- Lead the technology transfer of assays for implementation and qualification/validation at CROs/CMOs
- Communicate research and development findings, including formal technical reports and oral presentations.
- Assess and implement new analytical technologies
- Mentor and supervise 1-2 associates/scientists
- PhD in Biochemistry, Molecular Biology, or related field, with at least 8 years of post-PhD relevant industry experience or Master's degree with 10+ years of relevant industry experience.
- Bioassay and potency assay development along with appropriate cell and tissue culturing experience.
- Demonstrated experience supervising, training and mentoring multiple analytical development scientific staff.
- Experience in analytical method development, qualification/validation and transfer for Phase I/II clinical trials
- Understanding of FDA, EMA and ICH regulations, industry standards and quality control principles for GMP assay development, qualification and validation.
- Excellent oral and written communication skills
- Experience with biochemical and biological characterization of immune cells or immuno-oncology products.
- Experience in assay development for cell and gene therapy products
- Demonstrated publication and presentation record showing scientific leadership in the field of cell and gene therapy
- Experience in analytical method development and validation for Phase III clinical trials and commercial products
- 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.
If interested and qualified, please include Requisition # 2018-399 in the subject line when emailing resume to: email@example.com.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.