Manager, Quality Control and Stability

Categories: CMC (MFG)
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, Quality Control (QC) and Stability will perform quality control functions for active pharmaceutical ingredients (API) and drug product (DP), joining its growing and dynamic team. This job will report to the Senior Manager, QC and Stability. 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 people with endocrine diseases and endocrine-related tumors.

Essential Job Functions and Responsibilities:

These may include but are not limited to:
  • Manage release testing and stability programs for various projects in preclinical and clinical development internally or at external parties.
  • Author, review, and approve stability protocols; responsible for planning, execution, data management, data analysis, and data trending to support drug substance (API)/drug product retest period/shelf-life determination.
  • Manage reference material program.
  • Review raw data to support release testing, stability testing, and reference materials qualification.
  • Manage, report, and trend stability data. Escalate trends and support associated investigations, including temperature excursion assessment, client and regulatory requests.
  • Own and support stability-related deviations, investigations, CAPAs, and change controls.
  • Work in close collaboration and support with other members of the CMC team responsible for API and DP development and provide support to management as necessary.
  • Support regulatory filings (including INDs, IMPDs, NDAs, briefing packages, and other regulatory dossiers), specifically stability and reference material sections.
  • Recommend updates and participate in authoring/reviewing of the department related Standard Operating Procedures and guidelines.
  • Maintain QC SOPs, methods, specifications, and other associated documents.
  • Review analytical methods, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with cGMP and company standards.
  • Support QA on quality system and compliance activities, including audit functions.
  • Stay current on industry trends, practices, and regulatory guidelines.
  • Present stability updates to various internal audience.
  • Other projects (e.g., review method qualifications, specifications), as deemed appropriate.
 
Education and Experience:
Required:
  • A Bachelor’s degree with at least 8 years of experience or master’s degree in chemistry or related field with at least 5 years of related technical experience
  • Industry experience in a biotech or pharma company
  • Experience in contract laboratory relationship management
  • Experience in analytical testing
  • Versed in reviewing and analyzing release and stability data for trending and shelf-life determination
  • Proficient with analytical techniques that include but are not limited to LC, GC, KF, UV-Vis, FT-IR
  • Understanding of cGLP and cGMP requirements, compendia testing, and ICH and regulatory guidelines including stability data requirements
  • Strong knowledge of cGMP and industry standards
  • Excellent interpersonal and communication skills (written and oral). This includes the ability to effectively and accurately present data to peers, management, and external partners.
  • Ability to work in a goal and team-oriented setting and handle competing priorities
  • Flexibility within a rapidly changing environment and high attention to detail
  • Well-developed organizational skills and the ability to thrive under pressure
Preferred:
  • Experience in quality control and stability testing with a focus on small molecules
  • Experience with Laboratory Information Management System (LIMS) software
  • 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:  $93,000-$123,000
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.

 
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