Associate Director, CMC Analytical Development

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:

The Associate Director, Analytical Development will perform analytical research and development functions for active pharmaceutical ingredients (API) and drug product (DP), joining Crinetics’ growing and dynamic team. The Associate Director will oversee analytical activities for a specific program and will author/review analytical regulatory documentation to support 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:

• Establish and direct implementation of testing methodology and specifications for raw materials, intermediates, excipients, active pharmaceutical ingredients (APIs) and drug products (DPs), with focus on oral solid and parenteral dosage forms.

• Plan and oversee work at external contract analytical labs/vendors, including method development, qualification, transfer, and validation for API and DP.

• Plan and lead in-house analytical method development for API and DP (e.g., purity and related substances, dissolution).

• Write, review, and approve protocols and reports for analytical method qualification/validation, release/stability testing, and reference materials qualification.

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

• Ensure consistent implementation of analytical methods and product specifications at vendors/contract labs.

• 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.

• Evaluate, select, and develop relationships with external parties (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets, and timelines.

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

• Prepare for and participate in meetings with the FDA or other regulatory bodies as needed.

• Author and/or review department related Standard Operating Procedures, analytical methods, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with CGMPs and company standards.

• Support QA on quality systems, compliance activities, including audit functions.

• Participate in training and mentoring junior analysts.

• Manage financials for analytical activities on the specific projects.

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

• Other projects (impurity, identification, etc.) as deemed appropriate.

Education and Experience:

Required:

• A Bachelor’s/Master’s degree in analytical chemistry or related field with at least 10 years of related technical experience with increasing responsibility in biopharmaceutical development work in a biotech or pharma company (with a focus on small molecules).

• Experience in oral, solid and parenteral dosage forms.

• Excellent negotiation skills and a tactful approach that leads to high value on services obtained and outcomes achieved.

• Extensive experience in analytical testing, method development, and phase appropriate method qualification/validation and specifications for AP