About the Company
Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.
Position: Manufacturing Program Manager
Location: Massachusetts
Duration: Long Term
Job Overview
We are seeking an experienced Manufacturing Program Manager to lead global manufacturing programs for pharmaceutical, medical device, and combination products. This role focuses on product industrialization, technology transfer, manufacturing qualification, assembly, labeling, packaging, and product launches. The position requires strong program management, cross-functional coordination, risk management, and stakeholder communication skills.
Key Responsibilities
- Develop and manage program execution strategies, project plans, milestones, and timelines.
- Lead product transfers from development to manufacturing operations.
- Coordinate manufacturing, engineering, quality, regulatory, supply chain, and technical teams.
- Manage programs involving device manufacturing, combination product assembly, labeling, packaging, testing, and release.
- Develop program charters, Gantt charts, work breakdown structures, RACI matrices, and risk registers.
- Monitor program budgets, resources, schedules, and financial performance.
- Identify program risks, resolve issues, and implement mitigation and contingency plans.
- Coordinate material planning, sourcing, and distribution across global manufacturing locations.
- Support regulatory submissions, product launches, and commercial supply activities.
- Facilitate cross-functional meetings, track action items, and ensure timely completion of deliverables.
- Maintain program documentation, governance structures, and stakeholder communications.
- Drive continuous improvement, cost reduction, and efficient program execution.
Required Qualifications
- Bachelor's degree in Engineering, Science, or a related field.
- 10+ years of experience in pharmaceutical, biotechnology, medical device manufacturing, engineering, or technical operations.
- Minimum 5 years of global program or project management experience.
- Minimum 5 years of experience in drug product fill/finish, device manufacturing, or combination product assembly and packaging environments.
- Experience with product industrialization, manufacturing qualification, and technology transfer from development to operations.
- Strong knowledge of manufacturing operations, product assembly, labeling, packaging, and product launch activities.
- Proficiency in Microsoft Excel, Project, PowerPoint, Teams, and SharePoint.
- Experience developing program plans, timelines, risk registers, resource plans, and material supply plans.
- Strong stakeholder management, leadership, communication, problem-solving, and organizational skills.
- Ability to manage multiple priorities and lead cross-functional teams in a regulated environment.
- Experience with quality systems, design controls, regulatory submissions, and commercial supply is a plus.
- PMP certification, advanced degree, and experience with Power BI or Smartsheet are preferred.
How to Apply
Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.
Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.