Associate Director, Process Engineering

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, Process Engineering, will support mid- to late-stage manufacturing process development as part of the Manufacturing Science and Technology (MS&T) group within CMC. This job will report to the Director of MS&T and will manage activities related to drug substance and drug product process development, validation, and commercial manufacture. This individual will be an integral part of the company’s effort to develop and commercialize 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:

• Support efficient development of high quality and robust manufacturing processes using sound scientific and engineering tools to design, scale-up, characterize, and optimize manufacturing processes.

• Plan, direct, and oversee process development, manufacturing, and validation activities at contract development and manufacturing sites (CDMOs).

• Develop relationships with external parties (CROs, CDMOs, RM suppliers, consultants, etc.) and actively manage and oversee these external parties. Partner with drug substance and drug product teams to evaluate and select external parties for development and manufacturing.

• Manage priorities, timelines, and resources while also creating value by employing the best/most practical technologies, models, and simulation tools to enable efficient process characterization and optimization.

• Provide support for drug substance and drug product groups.

• Coordinate with CMC Drug Substance Development, Drug Product Development, and Analytical to build CMC timelines aligned with overall project timelines.

• Prepare development and manufacturing timelines and set clear deliverables for projects.

• Prepare and review request for proposal and statement of work, as well as associated budget.

• Provide budget, manage financials, and forecast resource expenditures, including expenditures with CDMOs and consultants.

• Evaluate relevant process and analytical data, monitor stability data, and prepare contingency plans.

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

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

• Collaborate with other members of CMC (Analytical, Drug Product, Drug Substance) to develop common, value-added procedures.

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

• Provide presentations and updates as necessary to multi-disciplinary development teams and as necessary to management.

• Other duties as assigned.

Education and Experience:

Required:

• Master’s degree in pharmacy, chemistry, chemical engineering, or related field with at least 8 years of related technical experience (an equivalent combination of experience and education may be considered).

• Lead work experience in drug substance or drug product development and clinical manufacturing for small molecules.

• Prior experience working with third parties, domestic and international, external service providers (CDMOs) desired.

• Understanding of cGMP requirements and ICH and national regulatory guidance is preferred.

• Excellent writing skills for preparation of regulatory documents and technical reports.

• Excellent oral comm