The Scientific Director of Analytical Strategy & Lifecycle plays a pivotal role in in developing, managing, and executing analytical CMC strategies essential for the transition of late-stage assets through commercialization and for supporting lifecycle of commercial products.
This senior individual contributor role requires deep expertise in biologics analytical sciences, and is responsible for independently design and implement robust analytical strategies, and strong technical writing skills to support regulatory submissions and global filing.The role will contribute scientific and regulatory leadership across assets, with responsibilities spanning analytical methods, specifications, reference standards, and comparability approaches.
Key deliverables include authorship of high-quality regulatory documents (e.g., justification of Specifications, analytical comparability protocols/reports, scientific briefing packages, responses to health authority questions) and providing subject matter expertise in analytical control strategies.
The position requires an experienced professional with the ability to influence in matrixed environments, communicate effectively with stakeholders, and deliver independently at the highest technical and regulatory standards.Key Responsibilities:Develop and execute analytical CMC strategy for late-stage assets transitioning to commercialization.Lead the design, authorship, and critical review of regulatory and technical deliverables including:Justification of Specifications (JOS)Analytical Comparability Protocols and ReportsScientific Briefing DocumentsResponses to Analytical Health Authority QuestionsProvide scientific expertise to the lifecycle management of analytical strategies across commercial products, including specification setting, method lifecycle management, reference standards, and comparability studiesServe as a subject matter expert in analytical sciences, advising cross-functional matrix teams and ensuring alignment with regulatory expectations.Partner effectively with Analytical Development, Quality, Regulatory, Process Sciences, Manufacturing, and Project Management to ensure strategies are executed with high scientific rigor and regulatory success.Provide scientific leadership and guidance during complex analytical troubleshooting, method updates, validations, and tech transfers.Ensure clarity, accuracy, and compliance in all technical deliverables.Operate as a senior independent contributor, proactively driving execution of the analytical control strategy and ensuring delivery of high-quality outcomes with minimal oversight.Qualifications & ExperienceExtensive knowledge and hands-on experience in analytical CMC for biologics, including:Specification settingAnalytical comparability strategy and risk assessmentsMethod lifecycle and change controlReference standard strategyProven track record of independently authoring complex regulatory and scientific documents (e.g., JOS, comparability reports, method validation summaries, regulatory responses).
Demonstrated ability to provide strategic input into regulatory submissions (IND, BLA, NDA, ROW, PAS) and manage health authority communications (IRs, FUMs, PMCs).
Strong technical writing and communication skills, with the ability to translate complex science into clear, compelling regulatory language.Highly skilled in leading, working within and influencing matrix teams; proven ability to drive alignment across functions without direct authoritySolid understanding of analytical methods commonly applied to biologics (iCIEF, UPLC, CE, Bioassay, ELISA, LC-MS, etc.).
In-depth knowledge of FDA and international regulatory guidelines and standards as well as extensive experience with supporting Health Authority inspections.Education/Experience/ Licenses/Certifications:A PhD, MS, or BS in Biological Sciences, Chemistry, or related disciplines with at least 15+ years of biologics experience within analytical CMC / relevant field, respectively.