Senior Director, Analytical Development & QC

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. 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. Come join our team as we transform the lives of others.

Position Summary:

The Senior Director will perform analytical research and development and Quality Control functions for active pharmaceutical ingredients (API) and drug product (DP), and the Senior Director will provide direction and oversight of all activities related to the analytical methods development, qualification, and validation. The Senior Director will oversee all API and DP release stability testing as well as analytical regulatory documentation to support global clinical studies. The Chemistry, Manufacturing and Controls (CMC) 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 effort to discover and develop small molecule therapeutics for rare endocrine disorders and endocrine-related-tumors. 

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide technical leadership and guidance across CMC development disciplines to all outsourced analytical methods and testing activities by providing clear objectives for multiple CDMO partners.

• Oversee the establishment of testing methodology specifications, and stability programs for raw materials, intermediates, excipients, APIs and DPs, including trend analysis, and retesting strategy for clinical trial materials.

• Manage analytical scientists and other skilled professionals and mentoring them in all matters related to drug development.

• Review and approve analytical methods, specifications, change controls, deviation, investigation, out-of-trend, or out-of-specification reports.

• Work in close collaboration and support with other members of the CMC team responsible for API and DP development and support to management as necessary.

• Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners.

• Negotiate, obtain, and review for accuracy legal and corporate approval for service agreements and related statements of work for development activities with external partners.

• Lead cross-functional teams (with Quality and Regulatory) in the selection of strategic CDMO, manufacturing, analytical, and partners, initially for all stages of development.

• Develop strong relationships with external said partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations.

• Prepare and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers).

• Create new systems/SOPs/policies and work with Quality Assurance to oversee these for compliance with current GXP regulations.

• Work with Regulatory, QA and Senior Management to ensure that all company policies are followed, and all external manufacturing activities comply with relevant regulations.

• Provide succinct and pertinent communication (oral and written) on the status of programs, CMC priorities and pending activities, across company functional areas and to senior leadership.

• Budget, manage financials, and forecast all analytical and stability related expenses.

• Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives and milestones.

• Supervise the building of in-house analytical development capabilities, from procurement of instrumentation to selection and design of laboratory space.

• Other duties as may be assigned.

Education and Experience:

Required:

• A PhD in analytical chemistry or related field with at least 13 years of analytical/CMC team leadership in the CDMO or pharmaceutical industry supporting small-molecule solid oral drug products, plus a minimum o