Product Lead Manufacturing (Pharma)

Role Summary The Product Lead Manufacturing (Pharma) is responsible for end-to-end product ownership across commercial pharmaceutical manufacturing operations. This role ensures robust, scalable, compliant, and cost-efficient manufacturing processes aligned with regulatory requirements and business objectives. The role bridges Technical Operations, Quality, Supply Chain, Regulatory Affairs, Engineering, and Commercial teams to drive lifecycle management, process optimization, technology transfer, and continuous improvement for assigned product(s) or portfolio. The ideal candidate combines strong pharmaceutical manufacturing expertise with product strategy, lifecycle management, and cross-functional leadership. Key Responsibilities Product Ownership & Strategy Own the manufacturing product strategy across lifecycle stages (launch scale maturity optimization). Define manufacturing readiness plans aligned with commercialization timelines. Develop and maintain Target Manufacturing Profile (TMP) and process control strategies. Lead capacity planning and long-term manufacturing strategy. Tech Transfer & Commercialization Lead technology transfer from R&D to commercial manufacturing. Ensure successful process validation (PPQ), engineering batches, and launch readiness. Drive cross-functional launch governance for new product introductions. Manage site selection and CMO coordination where applicable. GMP Compliance & Quality Ensure full compliance with cGMP, FDA, EMA, ICH, and local regulatory standards. Partner with Quality Assurance on deviations, CAPA, change control, and risk management. Maintain inspection readiness and support regulatory audits. Implement Quality by Design (QbD) principles and continuous verification programs. Process Optimization & Operational Excellence Improve yield, throughput, and cost of goods (COGS). Drive Lean, Six Sigma, and continuous improvement initiatives. Optimize batch cycle times and reduce manufacturing variability. Lead risk assessments (FMEA) and process robustness programs. Cross-Functional Leadership Collaborate with Supply Chain on demand forecasting and production planning. Align with Regulatory Affairs for post-approval changes and variations. Partner with Engineering on capital projects and automation initiatives. Present manufacturing strategy and performance updates to executive leadership. Financial & Performance Management Own manufacturing-related P&L elements for assigned products. Develop annual operating plans and cost-reduction strategies. Monitor KPIs including: OEE (Overall Equipment Effectiveness) Batch success rate Deviation rate Right First Time (RFT) COGS performance On-time-in-full (OTIF) delivery Experience 10 15+ years of experience in pharmaceutical manufacturing. Proven experience in oral solid dosage, injectables, biologics, or sterile manufacturing (as applicable). Hands-on experience with: Process validation and PPQ Regulatory inspections (FDA/EMA) Tech transfer and commercialization GMP documentation systems Experience managing cross-functional teams. Technical Competencies Deep knowledge of cGMP and global regulatory frameworks. Strong understanding of: Process validation lifecycle Cleaning validation Change management systems Stability programs Familiarity with MES, ERP, and digital batch record systems. Risk management methodologies (FMEA, HACCP). Leadership Competencies Strategic thinking with operational execution capability. Ability to influence without authority. Strong stakeholder management and executive communication skills. Data-driven decision making. Crisis management and problem-solving under pressure. Key Performance Indicators (KPIs) Successful commercial launch readiness Audit outcomes (zero critical findings) Yield and cost improvements Reduction in deviation trends Improved OEE and RFT metrics On-time tech transfer completion Education Bachelor s or Master s degree in Pharmacy, Chemical Engineering, Biotechnology, or related field. MBA or advanced management certification preferred.