Sr. Program Manager

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki

 

Join us 

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About This Role

The Senior Program Manager is accountable for the planning and delivery of programs from the point of contract signature (Scope of Work [SOW] / Letter of Intent / Contract) through program closure. This role provides services in alignment with our contracted commitment to clients and our company vision / mission (strategy and compliance). The Sr. Program Manager handles an average load of 1-3 programs and receives coaching and guidance from the Head of Program Management (PM) and peers within Program Management. The extension of this role includes support of FDBN PM team, and programs executed at FDBN site. Other functions of this role are supporting the initial customer interface and the Commercial organization, with input from PM, and supporting process design/regulatory knowhow in the initial phases of program design with the customer. The role actively participatesin the development of best practices to be deployed globally. The Sr. Program Manager engages with all areas, embracing a holistic approach to customer services / deliveries, ensuring that alignment with relevant stakeholders is in place.

 

What You’ll Do

Execution / Delivery:

• Leads the planning and execution of programs in alignment with FDB Program Management business case (vision, mission, SWOT/SIPOC, strategygoals-objectives)
• Onboards with Sales Team and transitions to become the primary liaison for program planning and execution upon notification that a Verbal Win / Letter of Intent has been confirmed by the Sales Team
• Engages impacted functional areas for inputs to ensure SOW elements are complete and realistic
• Ensures that the SOW is organized based on revenue-generating segments of work
• Ensures that financial activities and program milestones are aligned (e.g., SOW, PPS, revenue recognition milestones, change orders, invoicing/payment activities)
• Coordinates completion of the Contract elements (e.g., BSA-MSA, Quality Agreement, PPS, SOW)
• Develops and maintains Master Project Plan (MPP) including accurate durations and accountabilities for all revenue¬generating milestones throughout the scope of the program (e.g., contract sign, AD, Tech Transfer [TT], Clinical¬Commercial Manufacturing, Quality, QC, Release, Ship Deliverables, Transfer In (materials/equipment, methods, documentation), Transfer Out (materials/eqpt, methods, documentation)
• Partners with the Sales Team to identify opportunities for additional work within the current contract
• Partners with functional roles who oversee planning and execution to ensure that MPP revenue generating milestones are accurately translated into functional deliverables (e.g. Planning, QC-QA-PD-MFG readiness liaisons)
• Understands the approach and details of pricing strategy and sure that all work requested beyond the SOW/contract is covered by change orders
• Conducts cross-functional Program Kickoffs (Internal and Client) after contract is signed
• Assembles program core team, educates the impacted organization about the client, the molecule(s), indication, SOW
• Supports and drives TT activities, defines risks and mitigation actions (e.g., materials, equipment, long lead times, item specs, methods)
• Performs other duties, as assigned

Governance / Infrastructure:

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