External Manufacturing Manager

Amneal • Piscataway, NJ

8h • $150,000 - $160,000 • Onsite

About The Position

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.

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 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.

This position is onsite five days a week, from 9:00 AM EST to 5:30 PM EST. Work is performed in office and operational manufacturing environments. Occasional travel and additional on-site presence may be needed during selected campaigns, technology transfers, investigations, or inspections. The role operates in a fast-paced environment with time-sensitive manufacturing, quality, and supply priorities.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• 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 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, develop 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.
• 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 to align technical deliverables, documentation, materials, equipment, training, and facility readiness before execution.
• Track transfer plans, validation milestones, dependencies, risks, and decisions, maintaining clear ownership and due dates across project teams.
• Support manufacturing troubleshooting and facilitate timely resolution of technical and operational issues in coordination with accountable functions.
• Capture lessons learned and implement repeatable tools, templates, and operating practices across the assigned portfolio.
• 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.
• 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; partner with Finance, Procurement, and Legal on commercial decisions and contract changes.
• Identify opportunities to improve cost, efficiency, cycle time, quality, and partner performance, and develop recommendations for leadership approval when required.
• Communicate manufacturing status, supply risks, decisions, and required actions clearly to internal stakeholders and leadership.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award.
• Long-term incentive award, such as restricted stock units, within the first 12 months.
• Comprehensive, flexible, and competitive benefits program for eligible positions.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior