Septerna
Associate Director/Director, Analytical Development
Septerna, South San Francisco, California, us, 94083
Associate Director/Director, Analytical Development
Septerna is a biotechnology company based in South San Francisco, CA focused on developing life‑changing medicines for patients through a GPCR‑centric drug discovery approach. Our Native Complex Platform™ recapitulates GPCRs with native structure, function, and dynamics outside of the cellular context, enabling modern structural and screening technologies for industrial‑scale drug discovery of the entire class of GPCRs.
We are seeking an experienced and highly motivated Associate Director/Director of Analytical Development to manage and drive analytical development and quality control activities across our small molecule drug discovery and development programs. Reporting to the Vice President, CMC, this individual will serve as the subject‑matter expert (SME) and functional lead, contributing to the strategic direction, technical management, and operational execution for CMC development and manufacturing activities. The role will collaborate with and manage a network of consultants and CDMO partners to enable the discovery and development of small‑molecule therapeutics.
Responsibilities
Act as an SME for analytical development in drug substance and drug product development, including process chemistry, formulation development, and GMP manufacture.
Contribute to CMC control strategies, including development, review, and justification of specifications for raw materials, intermediates, drug substance, and drug product.
Develop analytical test methods and manage method validation and transfer as necessary to support CDMO GMP manufacturing, release, and stability.
Author and review analytical methods, protocols, reports, batch records, change controls, corrective and preventive actions, deviations, and investigations, including OOS and OOT events.
Write and review CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and remain current on health‑authority guidance.
Contribute to the development of CMC strategies to meet program and project targets, ensuring timely and high‑quality product delivery and regulatory approvals.
Support the quality system by authoring and reviewing SOPs, guidelines, and work instructions.
Establish and manage a reference standard program, including qualification and maintenance at CDMOs.
Support evaluation, selection, and management of CDMOs for process and method development, GMP manufacture, release testing, and stability studies.
Represent CMC in cross‑functional project teams, managing multiple priorities in a fast‑paced environment to ensure on‑time supply for IND‑enabling activities and clinical trials.
Qualifications
BS, MS, or PhD in analytical chemistry or related field with 6–16 years of progressive industry experience in analytical development.
Track record of delivering timely CMC activities from non‑GLP and IND‑enabling material supplies to GMP clinical‑trial supplies.
Expertise in analytical method development, qualification/validation, release and stability testing, and specification development.
Strong proficiency in IR, UPLC/HPLC, KF, GC, dissolution, and microbial limit tests; working knowledge of LC/GC‑MS, NMR, ICP, and solid‑state characterization techniques.
Understanding of quality systems, SOPs, GA, LIMS, cGMP data traceability, deviations, and change management.
Knowledge of ICH, FDA, MHRA, EMA guidelines and USP‑NF, Ph. Eur, BP, JP compendia.
Ability to manage and collaborate with external partners, consultants, and CDMOs.
Excellent written and oral communication skills and strong organizational/critical‑thinking abilities.
Travel up to 20% domestically and internationally as needed.
The anticipated salary range for this position in South San Francisco, CA is $185,000–$240,000, plus benefits, stock options, and an annual target bonus.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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We are seeking an experienced and highly motivated Associate Director/Director of Analytical Development to manage and drive analytical development and quality control activities across our small molecule drug discovery and development programs. Reporting to the Vice President, CMC, this individual will serve as the subject‑matter expert (SME) and functional lead, contributing to the strategic direction, technical management, and operational execution for CMC development and manufacturing activities. The role will collaborate with and manage a network of consultants and CDMO partners to enable the discovery and development of small‑molecule therapeutics.
Responsibilities
Act as an SME for analytical development in drug substance and drug product development, including process chemistry, formulation development, and GMP manufacture.
Contribute to CMC control strategies, including development, review, and justification of specifications for raw materials, intermediates, drug substance, and drug product.
Develop analytical test methods and manage method validation and transfer as necessary to support CDMO GMP manufacturing, release, and stability.
Author and review analytical methods, protocols, reports, batch records, change controls, corrective and preventive actions, deviations, and investigations, including OOS and OOT events.
Write and review CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and remain current on health‑authority guidance.
Contribute to the development of CMC strategies to meet program and project targets, ensuring timely and high‑quality product delivery and regulatory approvals.
Support the quality system by authoring and reviewing SOPs, guidelines, and work instructions.
Establish and manage a reference standard program, including qualification and maintenance at CDMOs.
Support evaluation, selection, and management of CDMOs for process and method development, GMP manufacture, release testing, and stability studies.
Represent CMC in cross‑functional project teams, managing multiple priorities in a fast‑paced environment to ensure on‑time supply for IND‑enabling activities and clinical trials.
Qualifications
BS, MS, or PhD in analytical chemistry or related field with 6–16 years of progressive industry experience in analytical development.
Track record of delivering timely CMC activities from non‑GLP and IND‑enabling material supplies to GMP clinical‑trial supplies.
Expertise in analytical method development, qualification/validation, release and stability testing, and specification development.
Strong proficiency in IR, UPLC/HPLC, KF, GC, dissolution, and microbial limit tests; working knowledge of LC/GC‑MS, NMR, ICP, and solid‑state characterization techniques.
Understanding of quality systems, SOPs, GA, LIMS, cGMP data traceability, deviations, and change management.
Knowledge of ICH, FDA, MHRA, EMA guidelines and USP‑NF, Ph. Eur, BP, JP compendia.
Ability to manage and collaborate with external partners, consultants, and CDMOs.
Excellent written and oral communication skills and strong organizational/critical‑thinking abilities.
Travel up to 20% domestically and internationally as needed.
The anticipated salary range for this position in South San Francisco, CA is $185,000–$240,000, plus benefits, stock options, and an annual target bonus.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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