Head of Chemistry Manufacturing and Controls (CMC)

Purpose:

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.

Responsibilities

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.

Preferred Background

• 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 hr@cellics.com.