CMC Manager – Cell & Gene TherapyA leading biomedical research organization dedicated to advancing transformative treatments for rare genetic disorders is seeking an experienced CMC Manager to join its growing Cell & Gene Therapy team.This is a strategic and hands-on leadership role responsible for driving Chemistry, Manufacturing & Controls (CMC) activities across advanced therapy programs from early development through commercialization.The RoleAs the CMC Manager, you will own and execute the CMC strategy for assigned programs, ensuring scientific integrity, regulatory compliance, and high-quality delivery throughout the product lifecycle. You will collaborate across internal functions and external manufacturing partners to enable successful discovery, clinical and commercial outcomes.You will play a key role in managing risk, ensuring product quality, safeguarding patient safety, and maintaining regulatory alignment while driving development timelines forward.Key ResponsibilitiesDefine and implement CMC strategy, incorporating Quality by Design (QbD) principlesLead and support regulatory CMC documentation (IND, IMPD, BLA, MAA submissions)Develop and maintain control strategies, stability programs, and comparability plansAssess regulatory impact of manufacturing and analytical changesOversee process development, optimization, scale-up, and technology transfer in GMP settingsCoordinate manufacturing activities for clinical trial supply and support commercial readinessDevelop raw materials strategy including supplier qualification, traceability, and risk mitigationCollaborate cross-functionally with Quality, Regulatory Affairs, Clinical, Supply Chain, and CDMOsSupport quality investigations and structured risk management activities (ICH Q9, FMEA)Contribute to CMC planning, milestone tracking, and overall program executionProfile:Education & ExperienceDegree in Chemistry, Pharmacy, Chemical Engineering, Biotechnology, or related scientific discipline (PhD preferred)7–8+ years of CMC experience within pharmaceutical or biotech environmentsTechnical ExpertiseStrong knowledge of ICH Q9, Q10, Q11, and M4(R2)Experience with Quality by Design (QbD)Structured risk management (FMEA)Technology transfer and process scale-upAnalytical method validationCMC comparability strategiesFluency in EnglishHighly DesirableExperience in nucleic acid-based manufacturing (e.g., mRNA, siRNA, plasmid DNA drug product)Key CompetenciesStrategic and systems-level thinkingStrong analytical and problem-solving skillsEffective decision-making with clear risk assessmentAbility to operate in cross-functional, matrixed environmentsExcellent communication and stakeholder management skills