Job Details

Target PR Range: 86-96/hr
*Depending on experience

As a Manufacturing Program Manager, you are responsible for leading large programs that involve multiple manufacturing, testing and storage locations across the globe.

The scope of the programs you lead typically includes assembly, labeling, packaging, testing, storage and release of new or modified medical devices and drug-device combination products.

You are responsible for creating and implementing program execution strategies, creating and maintaining program milestones and timelines, facilitating product and design transfer kick-off meetings, aligning global and site cross-functional project execution teams, planning material use, sourcing and distribution across the network, enabling regulatory submissions and supporting product launches.

Your role involves turning business goals into actionable project plans, establishing clear deliverables and milestones, communicating to stakeholders, removing barriers to success, managing risks, and driving collaboration across Manufacturing, Engineering, Science & Technology, Supply Chain, Quality and Regulatory.

You are expected to be a proactive, organized, leader with executive presence and strong communication skills that enable achievement of program goals and delivery of exceptional value.

Responsibilities:

1. Using a collection of program management tools, independently define and document the program scope, execution strategies, resources, deliverables and milestones.
2. Manage the program per its approved financial plan, ensuring that actual charges post as anticipated and communicate/resolve any financial variances.
3. Articulate the program execution strategy, deliverables and milestones to appropriate internal and external stakeholders maintaining a clear, consistent narrative to foster engagement, understanding and alignment.
4. Work collaboratively with the program team to implement effective program governance structures, work breakdown structures, roles and responsibilities, integrated timelines and communication plans.
5. Develop risk mitigation and contingency plans; implement as needed to keep the program on track.
6. Identify and realize opportunities that result in acceleration, efficiency and cost avoidance/reduction. Understand and integrate changes in the global landscape for device and combination product industrialization, global quality and regulatory requirements and pathways for approval/market access in programs to deliver acceleration and value.
7. Ensure the program team and stakeholders are aligned and the program is being executed efficiently. Manage competing timelines and make difficult decisions regarding priorities across the program. Drive rapid identification, communication and resolution of issues. Enable informed decision making, robust cross-functional problem solving and continuous improvement of program management practices and tools.
8. Plan and facilitate global meetings, document minutes and actions, follow-up on closure, and hold team members accountable for decisions and deliverables.
9. Ensure that programs and projects are technically and financially closed out upon completion and any on-going responsibilities are formally transferred to appropriate parties.

Qualifications:

1. Bachelor’s degree or equivalent in engineering or science. Advanced degrees and certifications such as Program Management Professional are a plus
2. 10+ years of combined professional experience in manufacturing, engineering, science & technology or technical operations for a pharma/biotech/device manufacturer.
3. Minimum of 5 years of global program and/or project management experience is required.
4. Minimum of 5 years of relevant experience in a drug product fill/finish, device manufacturing or combination product packaging plant environment is required.
5. Experience with industrialization/qualification of drug product fill/finish, device manufacturing and combination product assembly, labeling and packaging operations is required.
6. Experience with product transfer from development to operations is required.
7. Exposure to quality systems, design controls, product labeling, regulatory submission strategy/preparations and product launch/commercial supply are a plus.
8. Must have above average skills using MS Excel, MS Project, MS PowerPoint, MS Teams and SharePoint. Power BI/Smartsheet and open AI skills are a plus.
9. Must have the ability to create program charters, execution strategies, milestone tables, Gantt timelines, MS Project schedules, work breakdown structures, RACI matrices, risk registers and material demand and supply plans.
10. Excellent program and stakeholder management, written/verbal communication, active listening, negotiating, influencing and multi-tasking skills are required. Must be able to effectively facilitate cross-functional resolution of complex scientific, technical, analytical and business issues.
11. Strong financial skills and business acumen are preferred.
12. Proficiency in multiple languages is a plus.