Senior Manager, CMC Analytical Sciences

Position Summary

The Senior Manager, CMC Analytical Sciences is responsible for directing analytical activities conducted by external laboratories and contract development and manufacturing organizations (CDMOs) supporting Sabin’s pipeline. This role provides expert technical leadership in CMC analytical sciences, including the development, qualification, validation, and transfer of analytical methods, as well as stability program design and execution.

Responsibilities

• Lead the development, qualification, validation, and transfer of analytical methods (e.g., potency, purity, identity, and product-related impurities) for vaccine drug substance and drug product at Sabin’s CDMOs and external laboratories.
• Provide technical oversight and troubleshooting of analytical methods, including SME support for investigation of OOS (Out-of-Specification) and OOT (Out-of-Trend) results, deviations, CAPAs, and change controls.
• Author and review analytical and quality sections of global regulatory submissions (e.g., IND, IMPD, BLA, MAA, including Module 3 CTD sections).
• Provide 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 oversee ICH-compliant stability programs (e.g., ICH Q5), including forced degradation studies, real-time and accelerated testing, and shelf-life determination; support data compilation, review, and interpretation.
• Author analytical SOPs, templates, and guidance documents as needed.
• Compile, review, and analyze analytical data in support of development programs as required.
• Oversee the management of reference standards and sample inventories, as needed.

Requirements

• Bachelor’s degree in biochemistry, chemistry, biology, chemical engineering, or related pharmaceutical science required; advanced degree preferred.
• 9+ years of experience in biopharmaceutical product development, including management of CMC analytical activities; experience in vaccines, cell therapy, or gene therapy strongly preferred.
• Demonstrated experience overseeing CDMOs and/or managing remote external 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, light scattering, and cell-based potency assays.
• Proven ability to define and justify Critical Quality Attributes (CQAs) to ensure product safety, purity, and potency.
• Experience supporting GMP manufacturing process characterization strongly preferred
• In-depth understanding of US and EU CMC regulatory requirements.
• Comprehensive working knowledge of current Good Manufacturing Practices (cGMPs)
• Experience authoring CMC sections for INDs, NDAs, BLAs, and ex-US regulatory submissions.
• Demonstrated ability to manage complex priorities, work under pressure, and meet deadlines.
• Strong attention to detail with excellent organizational and problem-solving skills.
• Ability to operate with urgency, accuracy, and accountability in a fast-paced environment.
• Willingness to travel domestically and internationally as needed.

Other

• Subject to a criminal background investigation
• Request for three professional references
• Verification of education/degrees

Pay

Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $145,000 - $160,000. The exact compensation may vary based on skills, experience, training, and certifications/degree.

Benefits

• Medical, dental, and vision coverage
• Flexible spending accounts
• Flexible vacation and sick leave
• Employer-paid life and disability insurance
• 11 federal holidays and an end-of-year winter break
• Employer-matching 401(k) plan