External Manufacturing Manager

What You Will Own

• Day-to-day operational governance of assigned CMO/CDMO relationships, products, and manufacturing campaigns.
• Manufacturing schedules, readiness milestones, action tracking, risk visibility, and cross-functional follow-through for the assigned portfolio.
• Routine partner meetings, operational reviews, escalation coordination, and performance reporting.
• Operational support for technology transfer, validation, process changes, investigations, and continuous improvement.
• Clear communication of manufacturing status, supply risks, decisions, and required actions to internal stakeholders and leadership.

CMO Operations and Partner Performance

• Serve as the primary operational contact for assigned external manufacturing partners and maintain productive, accountable working relationships.
• Coordinate day-to-day manufacturing activities against approved production schedules, supply priorities, quality requirements, and program objectives.
• Lead routine operating meetings and contribute to quarterly or periodic business reviews using agreed metrics, risks, actions, and decisions.
• Monitor partner performance, including schedule adherence, on-time delivery, yield, right-first-time execution, deviation closure, and action-item completion.
• Identify execution risks early, develop practical mitigation plans with internal and external teams, and escalate issues through the appropriate governance pathway.
• Provide on-site person-in-plant support during selected engineering, validation, clinical, or commercial manufacturing campaigns when needed.

Technology Transfer and Manufacturing Execution

• Coordinate operational readiness for technology transfers, scale-up, process validation, PPQ, new-product introductions, and lifecycle changes at assigned CMOs.
• Partner with MSAT, CMC Development, Engineering, Quality, and Regulatory colleagues to confirm that technical deliverables, documentation, materials, equipment, training, and facility readiness are aligned before execution.
• Track transfer plans, validation milestones, dependencies, risks, and decisions; maintain clear ownership and due dates across the project team.
• Support manufacturing troubleshooting and facilitate timely resolution of technical and operational issues without replacing the accountable Quality, MSAT, Regulatory, or product-disposition functions.
• Capture lessons learned and implement repeatable tools, templates, and operating practices across the assigned portfolio.

Quality, Compliance, and Regulatory Support

• Ensure assigned manufacturing activities are planned and executed in accordance with cGMP, approved procedures, quality agreements, and applicable regulatory requirements.
• Partner with Quality to support deviations, investigations, CAPAs, change controls, complaints, audits, and inspection-readiness activities.
• Monitor the operational impact of quality events and coordinate recovery plans that protect patients, product quality, compliance, and supply continuity.
• Participate in audits and regulatory inspections as an operations representative or subject-matter contributor when requested.

Supply, Cost, and Cross-Functional Coordination

• Partner with Supply Chain to align demand, production, release, shipment, inventory, and material-readiness requirements for assigned products.
• Provide timely visibility to capacity constraints, schedule changes, material risks, and potential supply interruptions.
• Track costs, purchase-order or statement-of-work milestones, and budget impacts within the assigned portfolio; partner with Finance, Procurement, and Legal on commercial decisions and contract changes.
• Identify practical opportunities to improve cost, efficiency, cycle time, quality, and partner performance, and develop recommendations for leadership approval when required.
• Communicate clearly across Manufacturing, Quality, Regulatory, Supply Chain, MSAT, R&D, CMC Development, Finance, Procurement, and Legal.

Role Scope and Decision Boundaries

The initial scope is a defined portfolio of assigned CMO/CDMO partners, products, or programs, with the opportunity to expand as the external-manufacturing portfolio grows. The role executes approved strategy and recommends changes. Network strategy, major capital decisions, final contract authority, and enterprise portfolio prioritization remain with senior leadership and the appropriate functional owners. The role leads primarily through matrix influence. Direct supervisory responsibility may be added as the organization and portfolio grow. Quality retains independent authority for quality-system decisions and product disposition.