Job Title: Head of Chemistry and CMC
Department: Technical Operations
Reports To: CEO
FLSA Status: Exempt
Location: San Diego
The Head of Chemistry and CMC will join the dynamic Longboard’s team and oversee all early-stage chemistry and CMC-related activities to support the development of small molecule medicinal drug candidates from preclinical stage throughout clinical phases. The position is a high visibility, senior leadership and strategic role within the company reporting directly to the CEO. The candidate will lead the drug substance/drug product Process Development team and the QC/Analytical team and work with all other functions within the company in conjunction with external collaborators/contract research organizations. Working on projects spanning the entire pharmaceutical development spectrum, this role will be key in a corporate environment that is committed to developing and delivering novel, high quality pharmaceutical products to patients in need of safe and effective treatment options in a wide range of CNS indications.
- 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 processes are in accordance with cGMP, ICH (International Conference of Harmonization), and FDA/EMA regulations.
- Design and develop process optimization to support clinical manufacturing, scale up, technology transfer, validation and regulatory filings.
- Identify, select and manage Contract Development and Manufacturing Organizations (CDMO’s) for process optimization, cGMP manufacturing, and supply of drug substance and drug product in support of ongoing non-clinical and clinical activities.
- Oversee technology transfer including manufacturing process and analytical methods from Longboard to CDMO’s/CRO’s and vice versa.
- Ensure that all CDMO’s/CRO’s are using systems and processes in compliance with all relevant regulatory standards.
- Review/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 CMC activities.
- Evaluate small molecule candidates for further development including library design, lead optimization, solid state characteristics and scalability consistent with a target candidate profile to complement Longboard’s portfolio of medicinal drugs.
- Liaise with internal and external groups to ensure timelines and IND-enabling activities are on track.
- Mentor staff.
- MS or PhD degree in chemistry or a related scientific discipline with 15+ or 10+ years of experience in a pharmaceutical or biotechnology CMC/cGMP environment.
- Successful track record in designing and selecting small molecules for pharmaceutical development and oversight of activities leading to regulatory filings.
- Experience in managing CRO’s/CDMO’s for the manufacture of cGMP API and DP.
- Experience with IND and NDA filings and thorough knowledge of relevant FDA and EMA regulations.
- Strong project management skills across functional teams with a track record of proactive problem solving.
- Collaboration oriented and forward-thinking team player with leadership skills to achieve successful outcomes in a timely manner.
- Experience in supply chain management would be a plus.