Manufacturing Program Manager

Position Title: Manufacturing Program Manager

Location: Worcester, MA 01604

Contract Period: 18-24 Months

Shift Timings: Mon - Fri, 08:00 AM - 05:00 PM EST

MUST HAVE 10 YEARS OF MEDICAL DEVICE INDUSTRY EXP.

Must have drug device combination product exp.

Pharma/Biotech experience would not be considerable.

Length of Contract: 18-24mos

Location/Site: Worcester

Remote, 100% Onsite, or Hybrid Onsite Schedule: Hybrid – in office Tues/Wed/Thurs minimum

This is a Hybrid role

• Full-time, hybrid role; candidate is expected to be on site on Tue, Wed, Thurs
• Position is based in Worcester, MA
• Candidate must be able to travel domestically and internationally, if needed

Manager's Update:

• Pure pharma/small molecules industry exp. would not going to work
• This person must have a BS/MS degree in engineering and Science
• This is an administrative role but not a technical role
• Must have prior 5 years of exp. with drug products/combination products and global program management exp.
• Must have exp. with MS office based programs such as (MS Excel, MS Project, MS PowerPoint, MS Teams and SharePoint)
• Needs to manage the whole programs (Programs like: assembly, labeling, packaging, testing, storage, manufacturing sites)
• 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.
• Looking for Medical Device/Drug device manufacturing and Combination product exp.
• They are looking for a Manufacturing Program Manager
• This role is falls under a global team
• 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.
• This person needs to have exp. with New Product manufacturing/development, New Product launches and New product transfers
• Able to collaborate and communicate with stakeholders like directors, presidents and vice presidents
• Looking for 10 years of exp. within a regulated industry exp.
• Medical device exp. with product labeling and packaging exp. would be a requirement || Product design exp. would not relevant in this role
• Prior program management (primary focus) and some capacity of project management (secondary focus) exp. would be a requirement
• PMP certification would be nice to have but not a deal breaker
• This person needs to manage a lot of programs within the department but not going to do any project management stuffs.

Description

• 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:

• Using a collection of program management tools, independently define and document the program scope, execution strategies, resources, deliverables and milestones.
• Manage the program per its approved financial plan, ensuring that actual charges post as anticipated and communicate/resolve any financial variances.
• 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.
• Work collaboratively with the program team to implement effective program governance structures, work breakdown structures, roles and responsibilities, integrated timelines and communication plans.
• Develop risk mitigation and contingency plans; implement as needed to keep the program on track.
• 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.
• 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.
• Plan and facilitate global meetings, document minutes and actions, follow-up on closure, and hold team members accountable for decisions and deliverables.
• 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:

• Bachelor’s degree or equivalent in engineering or science. Advanced degrees and certifications such as Program Management Professional are a plus
• 10 years of combined professional experience in manufacturing, engineering, science & technology or technical operations for a pharma/biotech/device manufacturer.
• Minimum of 5 years of global program and/or project management experience is required.
• Minimum of 5 years of relevant experience in a drug product fill/finish, device manufacturing or combination product packaging plant environment is required.
• Experience with industrialization/qualification of drug product fill/finish, device manufacturing and combination product assembly, labeling and packaging operations is required.
• Experience with product transfer from development to operations is required.
• Exposure to quality systems, design controls, product labeling, regulatory submission strategy/preparations and product launch/commercial supply are a plus.
• 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.
• 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.
• 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.
• Strong financial skills and business acumen are preferred.
• Proficiency in multiple languages is a plus.