Director, Process Development Jobs

Position Summary
The Director of Process Development is responsible for managing the high performing organization, people, processes, procedures, business strategies, and the overall continuous building of a proficient Process Development department. The successful candidate will have technical expertise in cellular therapy and gene editing technologies, as well as leadership skills to manage a team of scientists and engineers. The Director of Process Development will oversee the development, optimization, and scale-up of processes for the production of engineered T cells, and will work collaboratively with cross-functional teams to ensure the successful implementation of these processes in a GMP environment. This role is based in Santa Monica, CA and reports to the Vice President in NL.

Responsibilities

• Build and sustain strong relationships with internal and external stakeholders to meet Business requirements.
• Periodically assess with customers that expected service level is being attained and strive to exceed expectations.
• Participate in regulatory authority interactions.
• Assist in managing the translation of research and development programs to GMP manufacturing.
• Drive the implementation of innovative, next generation cell processing technology for manufacture of cell therapies.
• Represent the process development functions in cross-functional team forums.
• 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.
• Provide guidance for technical operations team.
• 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.
• Drive process development group goals and assist in managing project plans, timelines and budgets.
• Promote the CMC strategy along with other Tech Ops functions.

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 manufacturing genetically modified cell therapy products, ideally both in industry and academia.
• Excellent data analysis skills and experience with a variety of scientific software applications.
• 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.
• Self-awareness, integrity, authenticity, and a growth mindset.
• 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 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.
• Experience in tech transfer and process characterization methods, manufacturing under cGMP, validation, and process comparability in a regulated environment.
• Exceptional talent builder & team leader – actively sought out by others as a coach & mentor.
• Ability to distill complex information and tailor verbal and written communications in a concise, logical, and audience appropriate manner.
• Experience with different modalities of genetically modified cell therapies (e.g. CAR-T, TCR, HSCs, CD34+, etc..).
• Self-motivated and willing to accept responsibilities outside of initial job description.
• Experience in developing & implementing cell therapy manufacturing processes and systems.
• Proficient experimental design and troubleshooting skills, with the ability to document laboratory procedures and experiments with great attention to detail.

The anticipated salary range for candidates who will work in Santa Monica, CA is $170,000 to $230,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.