Manager, Project Management 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 Manager, CMC Operations, will report to the Director, CMC Operations, and will support CMC leadership in the development and execution of operational plans, including production plans for clinical and commercial supplies. 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 project management support to CMC team leads for key programs.
• Facilitate development of and maintain adherence to project plans and timelines for key CMC activities.
• Ensure alignment between CMC objectives and overall corporate strategy.
• Liaise with project team members within CMC and across functions (including Quality and Regulatory) to drive successful completion of project deliverables.
• Collaborate with Clinical Trials Supplies (CTS) to ensure production activities for Investigational Product (IP) meets clinical demand needs and associated timing.
• Support in the preparation and review of regulatory filings, including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers.
• Maintain executive project dashboards, working in close collaboration with other members of the CMC team responsible for API, DP, ARD/QC, and CTS.
• Other duties as assigned.

Education and Experience:

Required:

• Bachelor’s degree in chemistry, chemical engineering, pharmaceuticals or biological sciences with a minimum of 7 years of relevant experience in the biotechnology or pharmaceutical industry
• A minimum of 2 years’ experience with managing vendors/CDMOs/CROs
• Must have expertise in Microsoft Office, developing and maintaining detailed timelines (Gantt charts, Microsoft Project, etc.).
• Must have exceptional organizational skills and be detail oriented.
• Excellent oral and written communication skills.

Preferred:

• Small molecule experience
• Project Management Professional (PMP) certification 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 of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5% of your time.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.