CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.Job Summary
We are seeking a Scientist to join the Technical Operations group, Regenerative Medicine franchise, at CRISPR Therapeutics. The successful candidate will ensure an induced pluripotent stem cell (iPSC) process is scaled from R&D to GMP manufacturing to support clinical trials. Additionally, this role will be responsible for technical contributions to our partnership with ViaCyte and the pancreatic-lineage cells for treatment of type 1 diabetes. Candidates with enthusiasm, passion, and a desire to create important new medicines for patients are highly favorable.Responsibilities
- Drive tech transfer strategy and execution of R&D-scale iPSC process to CDMO for process development and GMP manufacture.
- Develop and grow a platform process with a focus on biological aspects of iPSC reprogramming, expansion and differentiation.
- Develop CQAs and CPPs to ensure a robust process, including in-process and release analytics
- Bridge external CDMO and internal R&D in order to maintain alignment of process development strategy and execution
- Contribute to various regulatory submissions, communications, internal reports and procedures.
- Collaborate with R&D, Process / Analytical Development, Quality and Regulatory colleagues to achieve program and CMC goals
- PhD in molecular/cellular biology or biomedical engineering and 6+ years relevant industry process development experience.
- Expertise in process design and development for clinical manufacturing for autologous or allogeneic cell therapies
- Experience with iPSC reprogramming and differentiation into various cell types
- Demonstrated ability to lead a team in designing, executing, interpreting, and communicating experimental results
- Demonstrated ability to collaborate with team members and other functional groups on a project.
- Excellent oral and written communication skills
- Process and analytical development experience
- Highly organized with significant attention to detail and ability to develop younger staff
- Understanding of bioreactors systems, both upstream and downstream processes
- Working knowledge of DoE and QbD lifecycle
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.
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