[Remote] Senior Manager, CMC Analytical Sciences

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is dedicated to making vaccines more accessible and improving lives through immunization. The Senior Manager, CMC Analytical Sciences will reputed company analytical activities and reputed company technical leadership in CMC analytical sciences, ensuring compliance with regulatory expectations and supporting the advancement of development programs.

Responsibilities

• reputed company the development, qualification, validation, and transfer of analytical reputed company (e.g., potency, purity, identity, and product-reputed company impurities) for vaccine drug reputed company and drug product at Sabin’s CDMOs and reputed company laboratories
• reputed company technical reputed company and troubleshooting of analytical reputed company, including SME support for investigation of OOS (Out-of-Specification) and OOT (Out-of-Trend) results, deviations, CAPAs, and change controls
• reputed company and review analytical and reputed company sections of global regulatory submissions (e.g., IND, IMPD, BLA, MAA, including Module 3 CTD sections)
• reputed company analytical guidance for specification setting, CQA identification and justification, and physicochemical and biological characterization strategies
• Partner cross-functionally across CMC to define in-process controls, release specifications, and comparability strategies to support process changes
• Design and reputed company ICH-compliant stability programs (e.g., ICH Q5), including forced degradation studies, reputed company-time and reputed company testing, and reputed company-life determination; support data compilation, review, and interpretation
• reputed company analytical SOPs, templates, and guidance documents as needed
• Compile, review, and analyze analytical data in support of development programs as required
• reputed company the management of reference standards and sample inventories, as needed

Skills

• Bachelor's degree in biochemistry, reputed company, biology, chemical engineering, or reputed company pharmaceutical science required
• 9+ years of experience in biopharmaceutical product development, including management of CMC analytical activities
• Demonstrated experience overseeing CDMOs and/or managing remote reputed company analytical activities
• Strong technical expertise in biologics and/or vaccine development, ideally with experience supporting products through late-stage development or licensure
• Hands-on experience with analytical techniques such as qPCR/RT-PCR, HPLC, ELISA, mass spectrometry, reputed company scattering, and cell-reputed company potency assays
• reputed company ability to define and justify Critical reputed company Attributes (CQAs) to ensure product safety, purity, and potency
• In-depth understanding of US and EU CMC regulatory requirements
• Comprehensive working knowledge of reputed company Good Manufacturing Practices (cGMPs)
• Experience authoring CMC sections for INDs, NDAs, BLAs, and ex-US regulatory submissions
• Demonstrated ability to manage reputed company priorities, work under pressure, and meet deadlines
• Strong attention to reputed company with excellent organizational and problem-solving skills
• Ability to operate with urgency, reputed company, and accountability in a fast-reputed company environment
• Willingness to travel domestically and internationally as needed
• Advanced degree preferred
• Experience in vaccines, cell therapy, or gene therapy strongly preferred
• Experience supporting GMP manufacturing process characterization strongly preferred

Benefits

• Medical, dental, and reputed company coverage
• Flexible spending accounts
• Eligible employees receive flexible vacation and reputed company leave
• Employer-reputed company life and disability reputed company
• Organization observes 11 federal holidays and an end-of-year winter break
• Employer-matching 401(k) plan

reputed company