Head of Chemistry Manufacturing and Controls (CMC)
Full Time (San Diego)
Cellics Therapeutics Inc. is a rapidly growing biotech company located in San Diego, Sorrento Valley area – one of the major biotech hubs in the nation. Cellics is based on the award-winning Nanosponge technology and focuses on the development of novel nano-therapeutics and vaccines for hard-to-treat diseases. Cellics offers a highly motivational and rewarding working environment with attractive salary and benefits. Cellics is an Equal Opportunity Employer.
The Head of CMC 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. This position will report directly to the President/CMO.
The main responsibilities of the position include but are not limited to the following:
- Develop robust, scalable, and cost-effective manufacturing processes for drug substance (API) and drug product (DP);
- Design and develop formulations that meet target product profile for the clinic;
- Oversee all manufacturing activities from preclinical development through clinical phases;
- Implement stage appropriate analytical methods and protocols to ensure product quality;
- Execute plans for the validation and registration of drug substance and drug product as required by cGMP, ICH (International Conference of Harmonization), and FDA regulations;
- 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, review, or edit cGMP batch records, analytical methods, method validation reports, CMC regulatory and Quality documents;
- Write and review documents for regulatory submissions;
- 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.
- 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 liposome manufacturing and analytical processes.
- Experience with Cell growth and Cell reactor techniques and have the knowledge with membrane proteins from different cell types.
- Experience in managing International CRO/CMOs for the manufacture of cGMP API and DP.
- Experience in supply chain management would be a plus.
- Experience with IND, CTA, BLA, and NDA filings and thorough knowledge of relevant FDA and EMEA regulations.
- 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.