Manager, Quality Control & Stability

Manager, Quality Control & Stability

Crinetics is a pharmaceutical company based in San Diego, California, dedicated to developing therapies for endocrine diseases and endocrine‑related tumors. Founded by a team of scientists, we bring rigorous innovation to better lives. We have a prolific discovery engine and a robust preclinical and clinical development pipeline.

The Manager, Quality Control & Stability will perform quality control functions for active pharmaceutical ingredients (API) and drug product (DP) across preclinical, clinical and commercial programs. This role reports to the Associate Director, QC and Stability and works in collaboration with a global network of Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs).

• Manage release testing and stability programs for various projects in commercial, preclinical and clinical development internally or at external parties.
• Author, review, and approve stability protocols; responsible for planning, execution, data management, analysis, and trending to support drug substance (API)/drug product retest period/shelf‑life determination.
• Manage reference material program.
• Review raw data to support release testing, stability testing, and reference materials qualification.
• Manage, report, and trend stability data; escalates trends and supports investigations including temperature excursion assessment, client and regulatory requests.
• Own and support stability‑related deviations, investigations, CAPAs, and change controls.
• Work closely with other Technical Operations team members responsible for API and DP development and provide support to management as necessary.
• Support regulatory filings (INDs, IMPDs, NDAs, briefing packages, and other dossiers), specifically stability and reference material sections.
• Recommend updates and participate in authoring/reviewing of the department’s SOPs and guidelines.
• Maintain QC SOPs, methods, specifications, and other documents.
• Review analytical methods, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with cGMP and company standards.
• Support QA on quality system and compliance activities, including audit functions.
• Stay current on industry trends, practices, and regulatory guidelines.
• Present stability updates to various internal audiences.
• Other projects such as review method qualifications and specifications, as appropriate.

• A Bachelor’s degree with at least 7 years of experience or a master’s degree in chemistry or related field with at least 5 years of technical experience.
• Industry experience in a biotech or pharmaceutical company supporting commercial products.
• Experience in contract laboratory relationship management.
• Experience in analytical testing.
• Versed in reviewing and analyzing release and stability data for trending and shelf‑life determination.
• Proficient with analytical techniques including LC, GC, KF, UV‑Vis, FT‑IR, dissolution, XRPD.
• Understanding of cGLP and cGMP requirements, compendia testing, and ICH and regulatory guidelines including stability data requirements.
• Strong knowledge of cGMP and industry standards.
• Excellent interpersonal and communication skills (written and oral); ability to present data to peers, management, and external partners.
• Ability to work in a goal‑oriented, team‑oriented setting and handle competing priorities.
• Flexibility within a rapidly changing environment; high attention to detail.
• Well‑developed organizational skills and ability to thrive under pressure.

• Experience in quality control and stability testing with a focus on small molecules.
• Experience providing QC and stability testing support, including data review, for commercial/marketed products.
• Experience with Laboratory Information Management System (LIMS) software.
• Experience with electronic Quality Management Systems (eQMS), e.g., Veeva, including deviations, CAPA, and change control.

On a continuous basis, sit at a desk for a long period;…