Lead Scientist, Cell Therapy Process Development
We are seeking a Lead Scientist, Cell Therapy Process Development to join an exciting, fast-growing and well-financed company to develop novel gene editing therapies for serious diseases. This role will be a key technology leader to the development of late-stage CAR T cell manufacturing process for Phase III readiness and beyond. The ideal candidate will be a process engineer with experience in both late-stage process development, BLA-enabling study designs, and knowledge of T- cell biology, immunology, stem cell biology, and gene editing cell therapies
- Plan late stage process development activities for manufacturing process optimization, characterization and validation of CRISPR’s autogenic and/or allogenic CAR T cell programs to ensure Phase III readiness.
- Apply QbD principle and statistical design to establish unit operation robustness and improve manufacturing technologies for commercial success
- Evaluate new technologies and drive scientific innovation in CAR T cell process platform development
- Lead and execute both cell processes and in-process assays including trouble-shooting; report data and articulate impacts both internally and externally to stakeholders
- Write and review technical documentation, including SOPs, batch records, OQ/PQ protocols & reports, and validation plans/reports, to facilitate tech transfer, clinical manufacturing, and regulatory submissions
- Maintain a high-level technology knowledge in allogenic CAR T cell therapy process development and manufacturing; serve as SME and represent PD/Tech Ops in cross-functional project teams
- Opportunities will be provided to acquire new skills in an innovative and fast-paced environment
- Ph.D. in chemical engineering, cell biology or related science discipline with 3 to 10 years of relevant experienced in biologics development, MS/BS with 15+ years of relevant industrial experiences may be considered.
- Demonstrated track records of leading and driving innovative work from proof of concept through implementation.
- Experience in late-stage development activities such as process characterization, process validation, and commercial regulatory submission is highly preferred
- Expertise in cell-based assays including multi-color FACS and the ability to establish high throughput in-process analytics supporting late-stage process development for gene edited cell products is beneficial
- Experience in GMP manufacturing of Biologics and working with external partners such as CROs and CMOs; Knowledge of cell therapies, viral vectors, Cas9, and gRNA GMP manufacturing is a plus.
- Positive interpersonal skills with the ability to interact with individuals from different levels and functions.
- Demonstrated leadership to manage projects in a matrix environment
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. The sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.
If interested and qualified, please include Requisition # 2018-405 If interested and qualified, please include Requisition # 2018-XXX in the subject line when emailing resume to: firstname.lastname@example.org.
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.