Plant Transfer Program Manager

Job Description:

Lead end-to-end manufacturing and plant transfer programs within the regulated medical device industry, ensuring successful transfer of products, processes, technical documentation, and operations. Coordinate with Contract Manufacturing Organizations (CMOs), cross-functional teams, and quality functions to maintain supply continuity, regulatory compliance, and project milestones. Manage schedules, resources, budgets, risks, validation activities, and executive stakeholder communications.

Key Skills

• Program Management: Integrated project plans, schedules, critical paths, milestones, resource allocation, budgets, KPI dashboards, governance meetings, Microsoft Project, risk management, and executive presentations.
• Manufacturing & Process Transfer: Plant and product transfers, CMO coordination, Bills of Materials (BOMs), manufacturing instructions, process specifications, test methods, validation protocols, equipment parameters, product history records, pilot builds, engineering builds, and production qualification runs.
• Quality & Regulatory Compliance: FDA 21 CFR Part 820, ISO 13485, EU MDR, GMP, Quality Management System (QMS) transfer, IQ/OQ/PQ, process validation, cleaning validation, sterilization validation, and customer quality requirements.
• Supply Chain & Leadership: Inventory planning, procurement, logistics, warehousing, distribution, knowledge transfer, training, Lean Manufacturing, Six Sigma, stakeholder management, root cause investigation, financial analysis, and CAPEX tracking.

Required Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, Business, or a related field.
• 12+ years of Program/Project Management experience and 5+ years in the medical device industry, preferably involving sterile disposable medical devices.
• Demonstrated manufacturing, plant, product, or process transfer experience in regulated manufacturing environments, including coordination with CMOs or contract manufacturers.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, validation activities, and QMS transfer.
• Proven cross-functional leadership and stakeholder management, with responsibility for schedules, resources, budgets, risks, and milestones.
• Strong experience with Microsoft Project or equivalent project management software.

Additional Skills

• PMP certification or equivalent project management credential preferred.
• Experience with EU MDR and sterile disposable medical devices.
• Knowledge of sterilization and cleaning validation.
• Experience coordinating pilot builds, engineering builds, and production qualification runs.
• Familiarity with supply chain transitions, procurement, inventory planning, logistics, and distribution.
• Experience with financial analysis, project expenditure tracking, capital investments, and CAPEX monitoring.
• Knowledge of business continuity, contingency planning, SME coordination, training, and lessons-learned documentation.
• Willingness to work onsite in Arvada, Colorado.

For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on.

Benefits:

Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements. xhyhwjd

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.