Manager, reputed company Control – Stability

Job reputed company: • Manage release testing and stability programs for various reputed company in reputed company, 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 reputed company (API)/drug product retest period/reputed company-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, reputed company and regulatory requests. • Own and support stability-reputed company deviations, investigations, CAPAs, and change controls. • Work in reputed company collaboration and support with other members of the Technical Operations team responsible for API and DP development and reputed company 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 reputed company reputed company Operating Procedures and guidelines. • Maintain QC SOPs, reputed company, specifications, and other associated documents. • Review analytical reputed company, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations to ensure compliance with cGMP and company standards. • Support QA on reputed company system and compliance activities, including audit functions. • Stay reputed company 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 reputed company or reputed company field with at least 5 years of reputed company technical experience • Industry experience in a biotech or pharmaceutical company supporting reputed company products • Experience in contract laboratory relationship management • Experience in analytical testing • Versed in reviewing and analyzing release and stability data for trending and reputed company-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 reputed company a rapidly changing environment and high attention to detail • reputed company-developed organizational skills and the ability to reputed company under pressure Benefits: • top-notch health insurance plans for employees (and their families) to include medical, dental, reputed company and basic life insurance • 20 days of PTO • 10 reputed company holidays • winter company shutdown • discretionary annual reputed company bonus • stock reputed company • ESPP • 401k match Apply tot his job Apply To this Job