Director of Process Development
Proclinical is seeking a Director of Process Development for a cutting-edge biotech company located in Santa Monica, CA.
In this role, you will be responsible for managing the high performing organization, people, processes, procedures, business strategies, and the overall continuous building of a proficient Process Development department.
Must be eligible to work in the US.
- Drive process development group goals and assist in managing project plans, timelines and budgets.
- Establish the strategy and infrastructure for developing novel production processes for candidate engineered T cell therapeutics, ultimately leading to GMP-compliant manufacturing processes for early phase and late phase clinical trials.
- Assist in managing the translation of research and development programs to GMP manufacturing.
- Promote the CMC strategy along with other Tech Ops functions.
- Participate in regulatory authority interactions.
- Drive the implementation of innovative, next generation cell processing technology for manufacture of cell therapies.
- Provide guidance for technical operations team.
- Represent the process development functions in cross-functional team forums.
- Periodically assess with customers that expected service level is being attained and strive to exceed expectations.
- Collaborate with HR to build and develop an inclusive high performing team, develop the next generation of leaders by creating an inclusive culture, ensuring effective personal development of leaders.
- Build and sustain strong relationships with internal and external stakeholders to meet Business requirements.
Skills and Requirements:
- BS/BA in Biomedical Sciences, Bioengineering, or related field with 12+ years OR MS/MA with 8+ years OR PhD with 4+ years of aforementioned experience
- Experience with different modalities of genetically modified cell therapies (e.g. CAR-T, TCR, HSCs, CD34+, etc..).
- Experience in developing & implementing cell therapy manufacturing processes and systems.
- Experience with manufacturing genetically modified cell therapy products, ideally both in industry and academia.
- Experience in tech transfer and process characterization methods, manufacturing under cGMP, validation, and process comparability in a regulated environment.
- Knowledge across various manufacturing technologies used for cell and gene therapy including viral and non-viral genome engineering technologies.
- Experience with both autologous and allogeneic cell therapy manufacturing workflows is desirable.
- Excellent data analysis skills and experience with a variety of scientific software applications.
- Proficient experimental design and troubleshooting skills, with the ability to document laboratory procedures and experiments with great attention to detail.
- Demonstrated leadership & people management capabilities in driving change in complex, matrixed environments; can drive appropriate dialogue at the senior level to escalate & resolve issues; executive presence.
- Exceptional talent builder & team leader - actively sought out by others as a coach & mentor.
- Excellent verbal and written communication skills with the ability to interpret, summarize, and present scientific results in a concise manner to both technical and non-technical audiences.
- Self-motivated and willing to accept responsibilities outside of initial job description.
- Self-awareness, integrity, authenticity, and a growth mindset.
- Ability to distill complex information and tailor verbal and written communications in a concise, logical, and audience appropriate manner.
If you are having difficulty in applying or if you have any questions, please contact Julia Friedrich at +(1) 617-830-1584 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.