> Markdown version of [/jobs/ext/564592-senior-manager-cmc-analytical-sciences](https://www.wearedevelopers.com/jobs/ext/564592-senior-manager-cmc-analytical-sciences). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Manager, CMC Analytical Sciences - **Company:** Albert B. Sabin Vaccine Institute, Inc. (The) - **Location:** United States (Remote available) - **Experience:** Expert - **Salary:** $145,000.0 - $160,000.0 - **Contract:** Permanent contract - **Skills:** Data Analysis, Basic Linear Algebra Subprograms, Program Design Languages - **Published:** June 12, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=bc33587ffa56a721 ## About the Role Do you have experience in Regulatory submission editing and review?, Do you have a Bachelor's degree?, * 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. ## Description 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. The individual will collaborate cross-functionally within Sabin to ensure analytical strategies and deliverables meet current regulatory expectations and support timely advancement of development programs. 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. ## Related Videos - [Geometric deep learning for drug discovery](https://www.wearedevelopers.com/videos/264-geometric-deep-learning-for-drug-discovery) - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Startup Tech Presentations](https://www.wearedevelopers.com/videos/779-startup-tech-presentations) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [Software Security 101: Secure Coding Basics](https://www.wearedevelopers.com/videos/220-software-security-101-secure-coding-basics) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Find a Developer Job: 12 Best Job Sites For Developers](https://www.wearedevelopers.com/magazine/165-find-a-developer-job-12-best-job-sites-for-developers) - [Data Analyst Salary Germany](https://www.wearedevelopers.com/magazine/277-data-analyst-salary-germany) - [Starter Kit For Job Applications For Developers](https://www.wearedevelopers.com/magazine/7-starter-kit-for-job-applications-for-developers)