External Manufacturing Manager

The Manager, External Manufacturing Operations (EMO) is the primary operational contact for assigned contract manufacturing organizations (CMOs/CDMOs), products, and manufacturing programs. This hands-on role coordinates routine manufacturing execution, technology transfer, campaign readiness, issue resolution, and partner performance to support reliable supply and compliant delivery of biologic drug substance and/or drug product.

The Senior Manager works through a matrix and partners closely with Manufacturing, Quality, MSAT, Supply Chain, Regulatory, CMC Development, Procurement, Legal, and Finance. The role executes approved external-manufacturing strategy for an assigned portfolio, recommends improvements, and escalates decisions that require broader network, contractual, financial, or product-disposition authority. During critical campaigns, the Senior Manager may provide on-site person-in-plant support at external manufacturing facilities.

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.
  

Essential Duties & Responsibilities:

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 Senior Manager 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. The Senior Manager coordinates operational response and supply recovery in partnership with Quality and other accountable functions.

Minimum Qualifications:

Education:

• Bachelor's degree in engineering, biotechnology, biology, biochemistry, pharmaceutical sciences, life sciences, or a related discipline.

Experience:

• At least 10 years of experience in biomanufacturing, pharmaceutical manufacturing, technical operations, MSAT, supply operations, or another regulated life-sciences environment.
• At least 8 years of experience working in a GMP-regulated environment.
• Meaningful experience supporting or managing external manufacturing, CDMO/CMO relationships, outsourced manufacturing programs, or sponsor-CDMO operations.
• Working knowledge of biomolecule manufacturing, including one or more of the following: cell culture, fermentation, purification, formulation, aseptic processing, fill-finish, or biologic drug-product manufacturing.
• Experience coordinating manufacturing schedules, campaign readiness, technology transfer, validation, change control, deviations, CAPAs, or lifecycle activities.
• Demonstrated ability to lead cross-functional work through influence, establish accountability, resolve issues, and communicate effectively with technical and business stakeholders.
• Ability to travel occasionally and provide on-site support at external manufacturing facilities during critical activities.

Preferred Qualifications:

• Master's degree, MBA, or other relevant advanced degree.
• Three or more years of direct experience coordinating or managing one or more biologics CMO/CDMO relationships or outsourced manufacturing programs.
• Experience supporting clinical and/or commercial biologics, biosimilars, vaccines, cell and gene therapies, or other complex sterile products.
• Experience with partner scorecards, operational reviews, supply-risk mitigation, statements of work, purchase orders, cost tracking, or capacity planning.
• Experience serving as a technical or operational lead during CMO manufacturing campaigns, technology transfers, validation, PPQ, inspections, or major investigations.
• People leadership, mentoring, or team-development experience. Formal direct-report management is helpful but not required if strong matrix leadership is demonstrated.