Manager, Quality Control – Stability

Job Description: • 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 Apply tot his job Apply To this Job