Job Title: Associate Director/Director, Analytical Chemistry
Department: Technical Operations
Reports To: Head of Chemistry and CMC
FLSA Status: Exempt
Location: San Diego
This position is responsible for overall oversight of the Analytical Development activities of Longboard’s preclinical and clinical programs. The position is a high visibility role within the company reporting directly to the Head of Chemistry and CMC. The candidate will manage all analytical and related work to support small molecule drug substance/drug product development in conjunction with other functions within the company and external collaborators/contract research organizations. The ideal candidate will have shown proficiency in hands-on analytical techniques, the ability to manage activities, solve analytical challenges and have extensive experience reviewing and organizing analytical data. The position requires a strong background in drug substance and drug product analytical method development and validation, as well as thorough knowledge of analytical equipment, cGMP, ICH and relevant FDA guidelines. Experience managing CDMO’s/CRO’s is a must.
- Manage all analytical activities from preclinical development through clinical phases.
- Manage the development and implementation of stage appropriate analytical methods and protocols including method transfer, specifications, IPC’s, cleaning verification, stability studies, release testing of incoming materials, intermediates, API’s, reference standards and drug product.
- Provide technical and trouble-shooting support for analytical instrumentation and all analytical development activities.
- Author/review SOP’s, technical reports and relevant sections for regulatory filings.
- Actively communicate, consult and collaborate with colleagues and external contractors to ensure optimal execution and record of analytical activities.
- Works effectively outside the defined scope of responsibility when required and displays a bias for action/sense of urgency.
- PhD degree in analytical chemistry or related field with 8+ years of relevant experience, or equivalent combination of education (MS, BS) and industry experience.
- Significant experience in analytical method development of small molecule drug candidates.
- Experience in supporting all phases of API and formulation development, ideally from early stage to commercialization.
- Demonstrated in-depth understanding of cGMP manufacturing of biopharmaceutical products.
- Experience managing CRO’s/CDMO’s for the manufacture of cGMP API and DP.
- Experience with regulatory filings.
- Possess strong project management skills while maintaining high quality and efficiency standards.