Septerna · 3 hours ago
Associate Director, Process Chemistry
South San Francisco, California, United States
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$200K/yr - $225K/yr
7+ years expSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients. The Associate Director of Process Chemistry will manage and drive drug substance process development and delivery activities across small molecule drug discovery and development programs.
BiotechnologyInformation TechnologyMedicalSoftware
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
Qualification
Required
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
Benefits
Benefits
Stock options
Annual target bonus for full-time positions
Company
Septerna
Septerna is a biotech firm unlocking diverse drug discovery potential in G protein-coupled receptors across various diseases.
51-200 employees
H1B Sponsorship
Septerna has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
RA Capital ManagementThird Rock Ventures
2024-10-25IPO
2023-09-12Acquired
2023-07-11Series B· $150M
Leadership Team
Jeffrey Finer
CEO and Co-Founder
A
Arthur Christopoulos
Co-Founder
Recent News
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