Manager, Quality Control & Stability

Manager, Quality Control & Stability page is loaded## Manager, Quality Control & Stability remote type:
Hybrid-San Diego locations:
San Diego, CAtime type:
Full time posted on:
Posted Yesterday job requisition :
JR000546

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.
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* 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.
** Essential Job Functions and Responsibilities:
** These may include but are not limited to:
* 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.
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* Education and Experience:

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* 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…