Manager, Quality Control & Stability

Crinetics Pharmaceuticals • San Diego, CA

2d • $108,000 - $135,000

About The Position

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Manager, Quality Control (QC) and Stability will perform quality control functions for active pharmaceutical ingredients (API) and drug product (DP) across preclinical, clinical and commercial programs. This role will report to the Associate Director, QC and Stability. The Technical Operations team is highly collaborative with a global network of highly qualified Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs). This individual will be an integral part of the company’s efforts to discover, develop, and support the lifecycle of small-molecule therapeutics for people with endocrine diseases and endocrine-related tumors.

Requirements

• A Bachelor’s degree with at least 7 years of experience or master’s degree in chemistry or related field with at least 5 years of related 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 that include but are not limited to 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). This includes the ability to effectively and accurately present data to peers, management, and external partners.
• Ability to work in a goal and team-oriented setting and handle competing priorities
• Flexibility within a rapidly changing environment and high attention to detail
• Well-developed organizational skills and the ability to thrive under pressure

Nice To Haves

• 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) (Veeva preferred), including deviations, CAPA, and change control

Responsibilities

• 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, data analysis, and data 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.
• Escalate trends and support associated investigations, including temperature excursion assessment, client and regulatory requests.
• Own and support stability-related deviations, investigations, CAPAs, and change controls.
• Work in close collaboration and support with other members of the Technical Operations team responsible for API and DP development and provide support to management as necessary.
• Support regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers), specifically stability and reference material sections.
• Recommend updates and participate in authoring/reviewing of the department related Standard Operating Procedures and guidelines.
• Maintain QC SOPs, methods, specifications, and other associated 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 audience.
• Other projects (e.g., review method qualifications, specifications), as deemed appropriate.

Benefits

• In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
• We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees