Senior Specialist, GMP Quality Assurance

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 role of Senior Specialist, GMP Quality Assurance is primarily responsible for support of quality processes overseeing manufacturing and supportive operations in compliance with current Good Manufacturing Processes. This position will be responsible for performing batch record reviews as well as review analytical and microbiological testing with a drug substance and drug product lens. This role will work within the Quality Assurance team and support internal and external GMP audits.

Essential Job Functions and Responsibilities:

• These may include but are not limited to:
• Perform batch record review, and disposition related activities for Clinical and Commercial Supplies.
• Perform review and approval of analytical and microbiological testing raw data for the Drug Substance and Drug Product.
• Coordinate Quality Events (Deviations, CAPAs) with CMOs and escalate them to QA management.
• Oversee QA aspects of API, Drug Product and Packaging and Labeling Operations for Crinetics products, including reports, stability frameworks, EBRs, and other batch release documentation.
• Represent QA in internal and external team meetings.
• Support QA team on internal and external GMP audits.
• Support QA management on compiling Quality associated metrics.
• Write and review Standard Operating Procedures.
• Write internal investigations, as applicable.
• Compile metrics of Batch Disposition, deviations, CAPAs, as applicable.
• Other duties as assigned.

Education and Experience:

Required:

• Bachelor’s degree in Chemistry, Engineering or any other scientific discipline and 5 years of relevant experience in a GMP environment that constitutes Drug Substance, Drug Product, and Packaging and Labeling.
• Demonstrate knowledge of FDA/EMA/ICH standards and regulations.
• Demonstrate ability to effectively organize, and work in a fast-paced environment.
• Demonstrate ability to function individually and in a team environment.
• Equipment: Working knowledge of relevant manufacturing and analytical testing equipment and instrument.
• Software Knowledge: MS Office, e-QMS (e. g. Veeva), ERP systems.

Preferred:

• Solid dosage experience is preferred, however, experience in other dosage forms with relevant experience is acceptable.
• Prior experience with Electronic QMS systems (Veeva preferred).

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.

The Anticipated Base Salary Range: $83,000-$110,000

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.

#LI-MS1 #LI-remote