THE ROLEWe are seeking an experienced and highly motivated Associate Director of Process Chemistry to manage and drive drug substance process development and delivery activities across our small molecule drug discovery and development programs. This individual will fill a critical role as a subject matter expert (SME) and will contribute to the strategic direction, technical management, and operational execution for CMC development and manufacturing activities. This position is instrumental in collaborating with and managing a network of consultants and Contract Development and Manufacturing Organization (CDMO) partners to enable our efforts to discover and develop small molecule therapeutics from preclinical through commercial.
Responsibilities- Act as an SME for Process Chemistry in the support of drug substance development, including process chemistry, solid form selection, crystallization development, and GMP manufacture.
- Lead process development efforts, including route scouting, process optimization, and scale-up activities, proactively implementing mitigation strategies to ensure robust, cost-effective, safe, scalable, and phase-appropriate manufacturing processes.
- Contribute to CMC control strategies defining starting materials, impurity control strategies, and the specifications for starting materials, intermediates, and drug substance in alignment with industry standards and regulatory expectations.
- Support the evaluation, selection, technology transfer, and management of CDMOs to perform route and process development, and GMP manufacture.
- Contribute to the development of CMC strategies to meet program and project development targets, ensure timely and efficient delivery of high-quality products, and facilitate regulatory approvals.
- Collaborate closely within the CMC function with Analytical Chemistry and Formulation Development, and across cross-functional teams including Quality, Medicinal Chemistry, DMPK, Toxicology, Project Management, Development Sciences, and Clinical Pharmacology to achieve project goals.
- Manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of drug to support non-GLP toxicology studies, IND-enabling activities, and clinical trials across multiple programs.
- Support development of the Quality system to ensure product quality and data integrity, including authoring and reviewing standard operating procedures, guidelines, and work instructions.
- Author and review process development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigations.
- Write and review CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and the supporting technical documents, and remain current on Health Authority guidance and expectations.
Qualifications- A PhD, MS, or BS degree in organic chemistry or related field with a minimum of 7 years, 10 years, or 12 years, respectively, of relevant industry experience in small molecule drug substance development with demonstrated increasing responsibilities within process chemistry.
- Exhibited track record of success in delivering timely execution of drug substance activities ranging from non-GLP and IND-enabling material supplies, through GMP clinical trial supplies and commercialization.
- Demonstrated expertise in small molecule synthetic route evaluation, process development, scale-up and manufacturing, and phase-appropriate control strategy and specification development.
- Experience with analytical techniques to support small molecule process development, with proficiency in UPLC/HPLC, GC, MS, NMR, and solid-state characterization techniques such as particle size distribution and XRPD.
- Strong understanding of Quality systems including SOPs, manufacturing record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, Deviations, and Change Management.
- Demonstrated knowledge and application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.
- Proven ability to manage and collaborate with external partners, including consultants and CDMOs.
- Excellent interpersonal and communication skills (written and oral) with the ability to effectively prepare high-quality technical documentation and concisely present data to peers, management, and external groups.
- Exhibited strong organizational and critical thinking skills with an attention to detail and data integrity enabling sound, technically driven decision making.
- Able to travel domestically and internationally as needed, up to 20% of the time.
The anticipated salary range for candidates who will work in South San Francisco, CA is $200,000 - $220,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
