Senior Manager, CMC Operations

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. 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. Come join our team as we transform the lives of others.

Position Summary:

The Senior 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, budget management and forecasting, and governance of external partners).  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:

• Develop and maintain adherence to project plans, budget, and timelines according to regulations and corporate SOPs.

• Develop forecast for CMC Annual Budget, monitor spend and communicate forecast variances.

• Analyze key metrics and create reports.

• Support the project and portfolio division with CMC requirements on PMO initiatives (Planisware, resource algorithms, and standard duration timelines for product development), long range planning (LRP), and partnered programs.

• Liaise with project team members within CMC and across functions (including Quality and Regulatory) to drive successful completion of project deliverables.

• Provide project management support for CMC activities.

• Support CMC team in alignment of CMC goals and strategies with corporate and program goals.

• Support in development and implementation of a Sales and Operations Plan (S&OP).

• Support in the preparation and review of regulatory filings, including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers.

• Maintain and improve executive project dashboards, working in close collaboration with other members of the CMC team responsible for API, DP, ARD/QC, and CTS.

• Develop, maintain and improve CMC tools/trackers for regulatory submissions, batch genealogy, material inventories, program reviews, and vendor invoices.

• Manage contracts for CMC activities and associated purchase requests/orders.

• Provide support for executive governance of key partners.

• Other duties as assigned.

Education and Experience:

Required:

• Bachelor’s degree in chemistry, chemical engineering, pharmaceuticals or biological sciences with a minimum of 8 years of relevant experience supporting CMC operations (or related technical function) in the biotechnology or pharmaceutical industry

• A minimum of 5 years’ experience with budgeting and managing vendors/CDMOs/CROs or direct reports.

• 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

• Experience with global alliances 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.

Travel:

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

The Anticipated Base 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.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

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

Vaccination requirement:

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.