What are the responsibilities and job description for the Manufacturing Program Manager position at Katalyst CRO?
Position Overview
- The Manufacturing Program Manager will lead complex, global manufacturing programs involving new or modified medical devices and drug-device combination products. The role focuses on program strategy, execution planning, cross-functional coordination, risk management, manufacturing readiness, product transfers, and commercial product launches.
- The successful candidate will coordinate activities across Manufacturing, Engineering, Science & Technology, Supply Chain, Quality, and Regulatory teams to ensure programs meet established milestones, budgets, and business objectives.
- This is primarily a program management and coordination role, rather than a hands-on technical engineering or product design position.
- Define and document program scope, execution strategies, resources, deliverables, timelines, and milestones.
- Lead global manufacturing programs involving assembly, labeling, packaging, testing, storage, and product release.
- Develop and maintain integrated program schedules, Gantt charts, milestone plans, and work breakdown structures.
- Coordinate product and manufacturing transfers from development to commercial operations.
- Facilitate global kickoff meetings, governance meetings, stakeholder reviews, and cross-functional planning sessions.
- Align manufacturing sites and global teams to ensure effective program execution.
- Coordinate material planning, sourcing, distribution, and supply readiness across manufacturing networks.
- Manage program budgets, monitor financial performance, and address budget variances.
- Identify program risks, develop mitigation strategies, and implement contingency plans.
- Coordinate with Quality and Regulatory teams to support regulatory submissions, product approvals, and market launches.
- Track program progress, resolve execution barriers, and communicate risks and issues to senior leadership.
- Prepare program charters, RACI matrices, risk registers, milestone tables, and executive presentations.
- Identify opportunities to improve efficiency, reduce costs, accelerate timelines, and strengthen program governance.
- Ensure proper program closeout and transition ongoing responsibilities to appropriate teams.
- Bachelor's degree in Engineering, Science, or a related discipline; an advanced degree is preferred.
- 10 years of professional experience in a regulated manufacturing, medical device, engineering, or technical operations environment.
- At least 5 years of global program and/or project management experience.
- At least 5 years of relevant experience in device manufacturing, combination product packaging, or a closely related manufacturing environment.
- Demonstrated experience with combination product assembly, labeling, packaging, qualification, and industrialization.
- Experience managing product transfers from development to manufacturing operations.
- Experience with new product introduction (NPI), manufacturing readiness, and product launches.
- Strong understanding of cross-functional program execution, stakeholder alignment, and risk management.
- Advanced proficiency in MS Excel, MS Project, PowerPoint, Teams, and SharePoint.
- Excellent communication, organizational, presentation, negotiation, and leadership skills.
- Ability to work effectively with senior stakeholders, including directors, vice presidents, and executive leadership.
- Willingness to travel domestically and internationally as needed.
- PMP certification or equivalent program management credentials.
- Experience with quality systems, design controls, product labeling, and regulatory submission preparation.
- Knowledge of commercial supply readiness and global regulatory requirements.
- Experience with Power BI, Smartsheet, and AI-enabled productivity tools.
- Strong financial management skills and business acumen.
- Multilingual communication skills.
- 10 years of experience in the medical device industry or a closely relevant regulated manufacturing environment.
- Minimum 5 years of experience in global program management.
- Strong experience with drug-device combination products.
- Experience in medical device manufacturing, combination product assembly, labeling, and packaging.
- Experience with new product manufacturing, product launches, and product transfers.
- Experience coordinating global manufacturing programs across multiple sites.
- Bachelor's or master's degree in Engineering or Science.
- Strong knowledge of MS Excel, MS Project, PowerPoint, Teams, and SharePoint.
- Ability to work onsite in Worcester, MA, Tuesday through Thursday.