Associate Director, CMC OPEX

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, CMC OPEX, will report to the Director, CMC Operations, and support CMC leadership in the development and execution of operational plans that will streamline CMC processes and drive operational excellence within the department.  Responsibilities include identifying and improving department tools and trackers, collaborating with key stakeholders in the organization (such as Legal, Finance, and Project Management), and managing financials for the department.

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:

• Identify and create opportunities to streamline CMC processes and drive operational excellence.

• Develop, maintain, and improve internal CMC tools/trackers for production schedules, regulatory submissions, batch genealogy, material inventories, program reviews, etc.

• Manage department budget by preparing quarterly forecasts and long range plan (LRP), monitoring spend, tracking vendor invoices, and communicating budget variances.

• Manage contract lifecycles in collaboration with Legal department (includes submission of CMC work/change orders for Legal review, purchase order requests, etc.).

• Support the project and portfolio division with CMC requirements on PMO initiatives (Planisware, resource algorithms, and product development timelines) and partnered programs.

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

• Provide support for CMC project management and CMC outsourcing and vendor governance (CMC OVG).

• Other duties as assigned.

Education and Experience:

Required:

• Bachelor’s degree in chemistry, chemical engineering, pharmaceuticals or biological sciences with a minimum of 10 years of relevant experience in the biotechnology or pharmaceutical industry.

• Solid understanding of drug development and development operations within CMC.

• Strong leadership skills, with the ability to manage multiple high-priority projects in parallel.

• Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.

• Excellent computer skills including advanced knowledge in MS Excel, Word, PowerPoint and Outlook.

• Must be strategic as well as hands-on.

• Must be a self-starter who works with minimal supervision.

• Works effectively in a matrix cross-functional environment.

• Good business judgment and a strong understanding of the unique aspects of CMC financials.

• Excellent communication skills, (verbal and written) including the ability to understand and present information effectively.

• High sense of accountability/urgency.

Preferred:

• Master’s degree in chemistry, chemical engineering, pharmaceuticals, or biological sciences with a minimum of 8 years of relevant experience in the biotechnology or pharmaceutical industry.

• Operational excellence certification with Lean Six Sigma experience is a plus

• Expertise in Teams, SharePoint, Veeva, and SmartSheets is a plus

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period o