Overview
Remote
On-site
Job Description
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.
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FAQs About Manufacturing Program Manager Jobs at Katalyst Healthcares & Life Sciences
What is the work location for this position at Katalyst Healthcares & Life Sciences?
This job at Katalyst Healthcares & Life Sciences is located in Worcester, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
What employment applies to this position at Katalyst Healthcares & Life Sciences?
The employer has not provided this information. This may be discussed during the hiring process.
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