The Manager, Manufacturing NPI and Clinical Readiness, is responsible for leading and coordinating cross-functional activities to ensure successful manufacturing readiness, technical transfer, and early lifecycle execution for cell therapy products. This role bridges technical execution and program leadership by owning key readiness deliverables (documentation, MES, training, and risk management) while driving alignment across Manufacturing Operations, MSAT, Quality, Engineering, IT/ MES, and Supply Chain. The Manager operates with a high degree of independence, serving as a functional lead for discrete programs or workstreams, ensuring processes are scalable, inspection-ready, and aligned with clinical and commercial manufacturing objectives. Duties/ Responsibilities. Manufacturing Readiness & Technical Execution - Lead end-to-end manufacturing readiness activities for assigned programs, including documentation, MES recipe readiness, training, and execution support. - Ensure batch records, SOPs, and MES workflows are technically accurate, compliant, and aligned with process design and control strategies. - Coordinate readiness timelines across functions to support engineering runs, clinical manufacturing, and product launches. - Provide on-the-floor support during key manufacturing campaigns and tech transfer phases to ensure successful execution and rapid issue resolution. Technical Transfer & Program Coordination - Support and co-lead technical transfer activities, ensuring alignment of process, facility, and organizational readiness across stakeholders. - Act as a primary point of contact for cross-functional readiness activities, facilitating communication, issue resolution, and decision-making. - Track and communicate program status, risks, and key metrics to stakeholders and leadership. Risk Management & Compliance - Lead cross-functional risk assessments (e.g., FMEA) and ensure mitigation strategies are defined, tracked, and executed. - Identify and escalate risks that may impact safety, product quality, or manufacturing timelines. - Ensure all readiness activities align with cGMP expectations and inspection readiness standards. Cross-Functional Leadership - Lead or represent Manufacturing NPI within Technical Product Teams, driving execution of technical plans and readiness strategies. - Partner with QA, QC, MSAT, Regulatory, Engineering, and IT/ MES to resolve technical and compliance issues. - Influence decisions through technical expertise and data-driven recommendations. Continuous Improvement & Operational Excellence - Apply OPEX and lean principles to improve process efficiency, documentation quality, and manufacturing reliability - Identify opportunities for process optimization and scalability during technical transfer and early lifecycle manufacturing. - Contribute to initiatives improving MES usability, documentation robustness, and execution performance. Team Leadership & Development - Provide guidance and mentorship to senior specialists and specialists, supporting technical development and execution consistency - May lead workstream teams or matrixed project resources to deliver program objectives. Promote a safety-first and quality-driven culture across all activities. Qualifications:Specific Knowledge, Skills, Abilities:o Strong technical knowledge of sterile manufacturing technology and processing techniques.o Strong understanding of equipment qualification, maintenance practices, and GMP facility operations.o Strong strategic and analytical thinking, problem solving, and rapid decision-making skills.o Proven success in leading complex programs or projects across multiple departments.o Excellent communication skills, with the ability to influence and align stakeholders.o Experience in facility startup, technology transfer, or large-scale program execution preferred. Education/ Experience/ Licenses/ Certifications:o Bachelor’s or Graduate degree in Engineering, Life Sciences, or related field required.o 6 years of experience in a GMP-regulated environment, preferably in biologics or cell therapy manufacturing.o Prior experience in cell therapy or biologics manufacturing preferred.o Experience with technical transfer, manufacturing readiness, or process scale-up preferred. BMSCART#LIHYBRID -