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 Now
Apply Now
• 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 Now
Apply Now