Head of Chemistry Manufacturing and Controls (CMC)
Senior Vice President, Head of Non-Clinical Development and Medicinal Chemistry
The Head of CMC will be responsible for CMC-related activities, including development and manufacturing of drug substance (API) and drug product (DP), to support preclinical development through supplies for clinical phases.
- Identify, select and manage Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of API and DP in support of ongoing non-clinical and clinical programs
- Deliver robust, scalable and cost-effective manufacturing routes for API manufacturing
- Design and develop formulations that meet target product profile for the clinic
- Implement stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
- Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents. Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations. Writing and reviewing documents for INDs / regulatory section submissions
- Anticipate and project API and DP needs for preclinical and clinical programs and associated budgets, in collaboration with Asceneuron’s Management Team; manage supply chain and logistics in support of clinical studies
- PhD or MS in Pharmaceutical Chemistry, Organic Chemistry, Analytical Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
- 6+ years of experience in a pharmaceutical or biotechnology CMC/cGMP environment and experience in small molecule manufacturing
- Experience in managing International CRO/CMOs for the manufacture of cGMP APIs and DP. Experience in supply chain management would be a plus.
- Experience with IND, CTA and NDA filings; 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, within budget and in a timely manner
January 25th, 2019
Asceneuron SA does not accept referrals from employment businesses and/or employment agencies, and shall therefore not be liable for any fees incurred by employment businesses and/or employment agencies for referrals.