Director, Analytical CMC

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.

Position Summary:

The Director, CMC Analytical will report to the Senior Director, Analytical Development and Quality Control. 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.  This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

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

• Lead analytical development activities of the assigned projects and deliver business results for CMC Analytical

• Develop departmental processes to achieve department and corporate goals

• Focus on immediate and short-term (<2 year) strategic planning horizon

• Work closely with external CRO/CDMOs collaborators to c advance method development, qualification, transfer, and validation for API and DP for advanced programs

• Provide detailed review and approval for protocols, reports, and raw data for analytical method qualification/validation, release testing, and reference materials qualification

• Review and approve analytical methods, specifications, change controls, deviations, investigations, out-of-trend and/or out-of-specification reports

• Ensure consistent implementation of analytical methods and product specifications at CDMOs/contract laboratories

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

• Identify, evaluate, select, and develop relationships while actively managing external parties (CROs, CMOs, RM suppliers, consultants, etc.). This includes writing, reviewing, and managing requests for proposals, statements of work, contracts, budgets and timelines, and oversight on due diligence efforts

• Author and review CMC sections of regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers)

• Author and/or review departmental related Standard Operating Procedures and guidelines, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with cGMPs and company standards

• Effectively work with RA and QA on quality system to ensure up-to-date procedures, adherence, and compliance of vendors with cGXP regulations

• Participate as CMC subject matter expert in quality audits

• Identify and promote opportunities to streamline in-house CMC analytical development activities

• Provide leadership, career management and personal development to direct reports

• Recruit and develop top talent. Align team to needs of the business.

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

Education and Experience:

Required:

• Bachelor’s or master’s degree in analytical chemistry or related field with at least 12 years of related technical experience with increasing responsibility in biopharmaceutical development for small-molecule drug products, plus a minimum of 8+ years in a supervisory role

• Work experience in a biotech or pharma company (with a focus on small molecules in late phase of development) and extensive experience in oral solid dosage forms