Associate Director, Process Chemistry

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs.

Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date.

We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals;

and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.

We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the front lines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.

We 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.

• 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…