Project Manager (Manufacturing Transfer)

Intellectt Inc; Arvada (CO); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

None

Job summary

Intellectt Inc. seeks an experienced Project Manager to lead manufacturing and plant transfer initiatives in a regulated medical device environment. The role requires driving integrated project plans, coordinating product and process transfers, and ensuring timelines and quality standards are met.

Ideal candidates will have 12+ years in PM, 5+ years in medical devices, and strong governance and cross-functional collaboration skills. This is an onsite role based in Arvada, CO.

Qualifications

• 12+ years in project or program management.
• 5+ years in the medical device industry.
• Experience managing manufacturing transfer projects.
• Coordinate with CMOs or external partners.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, GMP.
• Experience with IQ/OQ/PQ and validation.
• Strong scheduling, risk, and budget management.
• Proficiency with Microsoft Project.

Responsibilities

• Develop and maintain integrated project plans with schedules, budgets, milestones.
• Execute manufacturing and plant transfer strategies with CMOs.
• Support governance structures and cross-functional workstreams.
• Drive decision-making and resource allocation across stakeholders.
• Monitor progress, risks, KPIs, and dependencies.
• Prepare status reports and governance materials.
• Facilitate cross-functional meetings to align teams.

Job description

Job Title: Project Manager - Manufacturing Transfer

Work Arrangement: Onsite

Experience: 12+ years in Project/Program Management, including 5+ years in the Medical Device industry

Job Summary

We are seeking an experienced Project Manager to lead manufacturing and plant transfer initiatives within a regulated medical device environment. The ideal candidate will have a strong background in project governance, manufacturing transfer, contract manufacturing partnerships, quality systems, process validation, and cross-functional stakeholder management.

The successful candidate will be responsible for managing integrated project plans, coordinating product and process transfers, mitigating risks, maintaining continuity of supply, and ensuring projects meet established timelines, quality standards, and business objectives.

Key Responsibilities

• Develop and maintain integrated project plans covering schedules, budgets, milestones, deliverables, resources, and critical path activities.
• Execute manufacturing and plant transfer strategies aligned with the overall contract manufacturing plan.
• Support project governance structures, steering committees, and cross-functional workstreams.
• Drive decision-making, issue resolution, and resource allocation across multiple stakeholders.
• Monitor project progress, risks, dependencies, and program-level KPIs.
• Prepare executive presentations, project status reports, and governance meeting materials.
• Facilitate cross-functional meetings to align teams, track milestones, and resolve issues.

Manufacturing & Product Transfer

• Coordinate the transfer of manufacturing processes, technical documentation, and production activities between sites.
• Ensure continuity of supply throughout the transition and stabilization phases.
• Oversee the transfer of:
• Bills of Materials (BOMs)
• Manufacturing instructions and work instructions
• Process specifications and test methods
• Validation protocols and reports
• Equipment parameters and product history records
• Coordinate pilot builds, engineering builds, and production qualification runs with contract manufacturing partners.
• Facilitate knowledge transfer and ensure receiving-site readiness.

Quality & Regulatory Compliance

• Ensure compliance with applicable FDA 21 CFR Part 820, ISO 13485, EU MDR, GMP, and customer quality requirements.
• Coordinate Quality Management System (QMS) transfer activities.
• Support validation planning and execution, including:
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Process validation
• Sterilization validation, where applicable
• Collaborate with Quality, Regulatory, Engineering, and Manufacturing teams to maintain documentation and compliance throughout the transfer.

Supply Chain & Procurement

• Coordinate inventory build strategies to support uninterrupted product supply.
• Manage transfer-related logistics, warehousing, procurement, and distribution activities.
• Collaborate with supply chain teams to identify material availability constraints and mitigate supply risks.

Knowledge Transfer & Stakeholder Management

• Coordinate subject matter expert (SME) engagement between originating and receiving manufacturing sites.
• Ensure appropriate training and certification of receiving-site personnel.
• Maintain transfer documentation, training records, lessons learned, and knowledge repositories.
• Manage relationships with contract manufacturing organizations (CMOs) and internal cross-functional teams.
• Facilitate discussions regarding priorities, timelines, resources, and deliverables.

Risk & Financial Management

• Identify and assess business continuity, supply chain, regulatory, operational, and capacity risks.
• Develop mitigation strategies, contingency plans, and recovery plans.
• Track project expenditures, cost savings, and transfer-related capital investments.
• Monitor resource utilization, budget performance, and project financial metrics.

Required Qualifications

• 12+ years of experience in project management or program management.
• 5+ years of experience in the medical device industry.
• Strong experience managing manufacturing, plant, or product transfer projects.
• Experience coordinating with contract manufacturing organizations (CMOs) or external manufacturing partners.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and regulated quality systems.
• Experience with IQ/OQ/PQ, process validation, and validation documentation.
• Strong project scheduling, resource planning, risk management, and budget management skills.
• Proficiency in Microsoft Project or equivalent project management tools.
• Excellent leadership, communication, analytical, and cross-functional coordination skills.
• Ability to influence stakeholders and drive outcomes without direct authority.
• Willingness to work onsite in Arvada, CO.

Preferred Qualifications

• Experience with sterile disposable medical devices.
• Knowledge of EU MDR requirements.
• Experience with cleaning and sterilization validation.
• Familiarity with Lean Manufacturing and Six Sigma methodologies.
• Experience with QMS transfers, production qualification, and supply chain transitions.
• Experience with CAPEX tracking, financial analysis, executive presentations, and governance meetings.
• Bachelor's or master's degree in Engineering, Life Sciences, Business, or a related discipline.

Key Success Metrics

• Completion of manufacturing transfer milestones according to the approved schedule.
• Achievement of project delivery targets.
• Effective risk mitigation and issue resolution.
• Successful transfer of manufacturing processes and supporting documentation.
• Maintenance of quality, regulatory compliance, and continuity of supply.

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

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.