Director, Pharmaceutical Development
Third Rock Ventures - San Francisco, CA
posted 4 days ago
About the position
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 frontlines 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.
Responsibilities
- Act as an SME for Pharmaceutical Development in the support of drug product development, including, form and formulation development, and GMP manufacture.
- Represent CMC and participate in cross functional project teams and 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 a portfolio of programs.
- Collaborate closely in cross-functional teams including but not limited to Medicinal Chemistry, DMPK, Toxicology, Quality, Project Management, Development Sciences, and Clinical Pharmacology to achieve project goals.
- Develop CMC strategies to meet program and project development targets, ensure timely and efficient delivery of high-quality products, and facilitate regulatory approvals.
- 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 technical development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigation.
- Define CMC control strategies, including development, review, and justification of specifications for raw materials, drug substance, and drug product in alignment with industry standards and regulatory expectations.
- Lead dosage form selection, formulation development, process optimization, and scale-up activities, ensure robust, cost-effective, and scalable manufacturing processes.
- Oversee technology transfer activities at CDMOs to ensure successful manufacturing and provide technical expertise in troubleshooting and resolving issues as necessary.
- 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.
- Lead the evaluation, selection, and management of CDMOs to perform formulation and process development, and GMP manufacture.
Requirements
- A BS, MS, or PhD degree in pharmaceutics, pharmaceutical sciences, chemical engineering, or a related field with a minimum of 16 years, 14 years, or 10 years, respectively, of relevant industry experience with demonstrated increasing responsibilities within pharmaceutical development.
- Exhibited track record of success in delivering timely execution of CMC activities ranging from non-GLP and IND-enabling material supplies, through GMP clinical trial supplies and commercialization.
- Demonstrated expertise in small molecule formulation development, including enabling formulations (e.g., amorphous solid dispersion), scale-up and manufacturing, and phase appropriate control strategy and specification development.
- Experience with analytical techniques for small molecules and oral solid dose products, with proficiency in UPLC/HPLC, dissolution, 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 and concisely present data to peers, management, and external groups.
- Exhibited strong organizational and critical thinking skills with an attention to detail enabling sound, technically driven decision making.
- Able to travel domestically and internationally as needed, up to 20% of the time.
Benefits
- Benefits package
- Stock options
- Annual target bonus for full-time positions.
