Manager, Quality Control – Stability
Crinetics Pharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $108,000 - $135,000 per year
About the role
- Manage release testing and stability programs for various projects in commercial, 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 Technical Operations 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.
Requirements
- A Bachelor’s degree with at least 7 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 pharmaceutical company supporting commercial products
- 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, Dissolution, XRPD
- 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
Benefits
- 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
- winter company shutdown
- discretionary annual target bonus
- stock options
- ESPP
- 401k match
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical testingdata managementdata analysisdata trendingrelease testingstability testinganalytical techniquesshelf-life determinationtemperature excursion assessmentCAPAs
Soft Skills
interpersonal skillscommunication skillsorganizational skillsteam-orientedflexibilityattention to detailability to handle competing prioritiesability to thrive under pressure