Head of Chemistry Manufacturing and Controls (CMC)
Full Time (San Diego)
The Head of CMC (VP level and up) will join the dynamic Cellics team and oversee all CMC-related activities to support company product development from preclinical stage through clinical phases. The candidate will lead the Process Development team and the QC/Analytical team and collaborate with other functional teams in the company to support product development. The Head of CMC will participate in the company’s executive committee and involved in the strategical discussions for the company.
The main responsibilities of the position include but are not limited to the following:
- Oversee all manufacturing activities from preclinical development through clinical phases;
- Develop robust, scalable, and cost-effective manufacturing processes for drug substance (API) and drug product (DP);
- Develop and implement stage appropriate analytical methods and protocols (independent generation, academic collaboration, or external vendor management) to ensure product quality;
- Execute plans to ensure that the manufacturing and QC process is in accordance with cGMP, ICH (International Conference of Harmonization), and FDA regulations;
- Design and develop process optimization to support clinical manufacturing, scale up, technology transfer, validation, and regulatory filings;
- Identify, select, and manage Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacturing, and supply of drug substance and drug product in support of ongoing non-clinical and clinical programs;
- Oversee technology transfer including manufacturing process and analytical methods from Cellics to CMO/CROs and vice versa;
- Ensure that all CMO/CROs are using systems and processes in compliance with all relevant regulatory standards;
- Prepare cGMP batch records, analytical methods, method validation reports, CMC regulatory and quality documents;
- Forecast drug substance and drug product needs and manage supply chain and logistics in support of preclinical and clinical programs;
- Prepare budget estimates and control costs for the CMC Department;
- Mentor junior CMC scientists.
- PhD or MS in Pharmaceutical Chemistry, Organic Chemistry, Analytical Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline.
- 10+ years of experience in a pharmaceutical or biotechnology CMC/cGMP environment.
- Experience in cell therapy, liposome, or biologics manufacturing and analytical processes is required.
- Experience with cell growth and cell reactor techniques and knowledge with membrane proteins from different cell types is preferred.
- Experience in managing CRO/CMOs for the manufacture of cGMP API and DP.
- Experience with IND, CTA, BLA, and NDA filings and thorough knowledge of relevant FDA and EMEA regulations.
- Strong project management skills across functional teams with a strong track record of proactive problem solving.
- Experience in supply chain management would be a plus.
- Proactive, forward-thinking, and a team player with leadership skills to achieve successful outcomes in collaboration with internal team and external collaborators in a timely manner.
If interested, please email a copy of your CV to firstname.lastname@example.org.