Program Manager

Overview

Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)

 

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 create 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 FDB call Genki

 

Summary:  The Program Manager, with mentoring and support from the Head of Program Management and/or Associate Program Director or Program Director, will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to program delivery including technology transfer and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure.  The Program Manager ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance). 

 

External US

Essential Functions:

• On board new customer programs with the Sales Team to transition to become the primary liaison for program planning and execution upon confirmation that a Verbal Win/Letter of Intent has been reached.
• Lead the planning and execution of programs in alignment with the FDBT Program Management business best practice (vision, mission, SWOT/SIPOC, strategy-goals-objectives).
• Oversee the general day-to-day execution of Program activities and planning to ensure on-time completion of Program tasks and deliverables as scheduled.
• Identify program delivery risks and mitigations and ensure the program team, the site leadership team, and the customer are appropriately informed.
• Lead the Program team in Stage Gate reviews as part of the program life cycle to communicate program readiness and risk profile to the site leadership team.
• Attend and lead daily Tier 2 and Tier 3 meetings to support FDBT’s communication structure for escalations and feedback in program risk items.
• Serve as the lead with the functional areas to ensure the SOW elements are accurate, complete, and organized based on revenue generating segments of work.
• Ensure financial activities and program milestones are aligned (SOW, PPS, revenue recognition milestones, change orders, invoicing/payment activities, etc.).
• Ensure all Contract elements (BSA-MSA, Quality Agreement, Price and Payment Schedule, SOW) are completed with support from Head of Program Management.
• Develop and maintain the Master Program Plan (MPP) including ensuring durations and accountabilities for all revenue generating milestones are accurate through the scope of the program (contract sign, PD US/DS, AD, Tech Transfer, Clinical-Commercial Manufacturing, QA, QC, Release, Ship Deliverables, Transfer in and Transfer out).
• Collaborate with the Sales Team to identify additional opportunities for additional work within the current contract.
• Partner with functional teams (QC, QA, PD, Manufacturing, etc.) to ensure that MPP revenue generating milestones are accurately translated into functional deliverables and all action items are completed per the committed timeline.
• Work closely with Process Development, Manufacturing, Engineering, Quality Control and Quality Assurance to reduce time to clinic or market, improve ease of manufacturing, and reduce costs when compared with existing platform products while achieving and maintaining full compliance (cGMP, Safety and Environmental).
• Accurately define timelines and resource requirements for the assigned Programs.
• Maintain Program documentation (change orders, Program reports, timelines, etc.).
• Manage and lead Program team meetings, including issuance of agenda, action items, meeting minutes, client communications, etc.
• Communicate Program updates to the Leadership Team at predefined milestones and at defined intervals.
• Organize and conduct Program team and Joint Steering team meetings with external clients including agenda, meeting notes, action items, and follow-up of action items.
• Track and report program performance (financial, delivery metrics and analysis, monthly reports, quarterly and annual leadership reviews, revenue change log, etc.); ensure accurate and timely completion of financial transactions (revenue adjustments/ recognition, chan