Senior Manufacturing Transfer Lead

Actalent

Charlotte (NC)

Hybrid

USD 130,000 - 150,000

Full time

4 days ago
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Benefits offered by this job

Medical, dental & vision
401(k) plan
Life Insurance
Disability insurance
Health Spending Account
Transportation benefits
Employee Assistance Program
Paid time off

Job summary

Actalent is seeking a Sr. Project Manager for Manufacturing Network & Process Transfer to lead cross-functional initiatives relocating medical-device products and capabilities across facilities or external partners.

You will determine the manufacturing model, develop business cases, secure decisions, and ensure quality, regulatory compliance, and supply continuity. The role requires collaboration with executive leadership, travel to sites, and experience with complex transfers, site

Qualifications

  • Bachelor's degree in Engineering, Operations, Business, Supply Chain, or a related discipline.
  • 8+ years of progressive project or program management experience, including responsibility for complex cross-functional initiatives.
  • 5+ years of project or program leadership within medical device, life sciences, or another highly regulated manufacturing environment strongly preferred.
  • Demonstrated leadership of manufacturing transfers, facility consolidations, insourcing, outsourcing, and/or contract-manufacturing transitions.
  • Strong business and financial acumen, including experience evaluating project economics, capital investment, cost structures, total cost, and business cases.
  • Exceptional executive-level written, verbal, presentation, and relationship-building skills.
  • Advanced project planning, risk management, issue resolution, decision facilitation, and organizational skills.
  • Working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation and ISO 13485:2016, plus applicable validation, change-control, and risk-management practices.

Responsibilities

  • Lead evaluation, planning, and execution of large-scale manufacturing process and production transfers across internal sites and external manufacturing partners.
  • Develop and compare scenarios including insourcing, outsourcing, contract manufacturing, site consolidation, and transfer to alternate internal facilities.
  • Establish decision criteria and evaluate capital requirements, operating costs, capacity, labor availability, technical capability, quality, regulatory requirements, supply risk, timing, and long-term strategic fit.
  • Facilitate cross-functional trade-off discussions and convert findings into clear recommendations for leadership approval.
  • Maintain business-continuity and supply-risk mitigation as core considerations throughout the transition.
  • Partner with Finance and business leadership to build financial models and business cases supporting manufacturing-network decisions.
  • Evaluate alternatives using capital investment, operating expense, transition cost, total cost of ownership, unit economics, expected savings, and return measures.
  • Track program budgets, forecasts, capital expenditures, financial commitments, savings, and variances throughout execution.
  • Serve as the primary program interface with executive leadership.
  • Prepare and present executive decision packages, dashboards, milestone reviews, risk assessments, financial implications, and recommendations.
  • Lead steering-committee governance and drive timely resolution of decisions, constraints, and escalations.
  • Translate complex technical, regulatory, operational, and financial information into concise business language.
  • Own the integrated program from feasibility and strategy through detailed planning, transfer, validation, production readiness, stabilization, and closure.
  • Manage scope, schedule, budget, resources, dependencies, milestones, assumptions, risks, issues, decisions, and change control.
  • Ensure appropriate transfer of equipment, tooling, processes, specifications, work instructions, quality records, manufacturing data, and process knowledge.
  • Coordinate process validation, equipment qualification, change control, supplier qualification, manufacturing readiness, and applicable regulatory deliverables.

Skills

Project management
Leadership
Regulatory knowledge
Cross-functional collaboration
Financial analysis
Executive communication
Risk management

Education

Bachelor's degree in Engineering/Operations/Business/Supply Chain

Job description

Actalent is seeking a Sr. Project Manager for Manufacturing Network & Process Transfer to lead cross-functional initiatives relocating medical-device products and capabilities across facilities or external partners.

You will determine the manufacturing model, develop business cases, secure decisions, and ensure quality, regulatory compliance, and supply continuity. The role requires collaboration with executive leadership, travel to sites, and experience with complex transfers, site

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