Senior Manager, CMC Analytical

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. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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:

Crinetics Pharmaceuticals is seeking a highly motivated professional to perform CMC analytical functions for active pharmaceutical ingredients (API) and drug product (DP), joining its growing and dynamic team. This role will work closely with the cross-functional CMC team to execute both early- and late-stage development activities in support of both preclinical and clinical phase I/II/III activities. This role will report to the Senior Director, Analytical Development and QC, and will be managing the activities related to methods of development, qualification, and validation for APIs, intermediates, and DPs, as well as support for all other analytical related activities from early phase development to commercialization. This position will be required to work independently and have significant hands-on experience on chromatographic method development.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Manage the development, qualification/validation, and transfer of analytical methods at contract laboratories.

• Review analytical documents and data from contract partners, providing feedback and facilitating resolution of technical or quality issues.

• Summarize experimental findings and interpret development and stability study results.

• Collaborate with other members of CMC and QA teams to ensure timely release of clinical products and resolution of product investigations.

• Support development of analytical methods internally.

• Monitor reference materials qualification and re-qualification.

• Develop relationships with external parties (CROs, CMOs, analytical testing laboratories, consultants, etc.) and actively manage and oversee analytical development and quality control activities at these external parties.

• Assist in selection and management of contract laboratories.

• Write, review and manage request for proposal, statement of work, contract, budget, and timelines.

• Support regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossier).

• Author and review department-related Standard Operating Procedures, analytical methods, technical reports, specifications and spec justifications, risk assessments, corrective/preventative actions, change controls, investigations, and deviations, to ensure compliance with cGMP’s and company standards

• Understand cross-functional needs in analytical API and DP development and provide appropriate support to management, as necessary.

• Stay current on industry trends, practices, and regulatory guidance.

• Provide presentations and updates as necessary to management.

Education and Experience:

Required:

• Minimum of a bachelor’s or master’s degree in analytical chemistry or related field with at least 8 years of related technical experience, or a PhD in analytical chemistry or related field with at least 6 years of related technical experience (an equivalent combination of experience and education may be considered).

• Direct work experience in analytical laboratory activities such as testing, method development, and qualification/validation for API and DP is required in a cGMP environment.

• A thorough understanding of phase appropriate methods qualification and/or validation and specifications.

• Prior experience managing third parties, domestic, and international external service providers.

• Well-versed in reviewing and analyzing release and stability data for trending and specification determination.

• A thorough understanding of analytical chemistry, and solid form science requirements.

• Hands-on experience with analytical development techniques used in pharmaceutical industry including PLC, di