Apply on Employer Site

Crinetics Pharmaceuticals · 19 hours ago

Manager, Quality Control & Stability

San Diego, CA

Full-time

Onsite

Mid, Senior Level

$108K/yr - $135K/yr

5+ years exp

Crinetics Pharmaceuticals is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases. The Manager, Quality Control & Stability will manage quality control functions for active pharmaceutical ingredients and drug products across various development stages, ensuring compliance and supporting the lifecycle of therapeutics.

BiotechnologyHealth CarePharmaceuticalTherapeutics

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

Qualification

Quality Control ManagementStability TestingAnalytical TestingCGMP ComplianceLaboratory Information Management SystemElectronic Quality Management SystemsInterpersonal SkillsOrganizational SkillsCommunication SkillsTeamworkFlexibility

Required

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