Head of Chemistry Manufacturing and Controls (CMC)
Full Time (San Diego)
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 under GMP guidance. 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 reports directly to the President/CMO and is a key member of the senior management team.
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;
- Lead appropriate talent development plans and help drive the company culture.
- 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.