Senior Program Manager

Position Overview

Program Manager is accountable for the planning & delivery of programs from the point of contract signature (Scope of Work / Letter of Intent /

Contract) through program closure. The PM ensures we provide services in alignment with our contracted commitment to clients and our company

vision/mission (strategy and compliance). The PM typically handles an average load of 1-3 programs and receives coaching & guidance from the Head of Program Management and peers within PM. The extension of this role can include support of the FDBN facility Program mgmt. team and programs executed at FDBN site.

 

Other functions of this role can extend to, Supporting the initial customer interface and the Commercial organization, with input from Program Mgmt.

and potentially also supporting with both process design/regulatory knowhow in the initial phases of program design with customer. Active participation in the development of best practices to be deployed globally extends the impact of this role, beyond sites and modalities. Engage with all areas, embracing a holistic approach to customer services / deliveries, ensuring that alignment with relevant stakeholders are in place.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do

 

Execution/Delivery:

• Lead the planning and execution of programs in alignment with FOB-Program Management business case (vision, mission,
• SWOT/SIPOC, strategy-goals-objectives).
• Onboard with Sales Team and transition to become the primary liason for program planning & 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.
• Ensure that the SOW is organized based on revenue-generating segments of work.
• Ensure that financial activities & program milestones are aligned (SOW, PPS, revenue recognition milestones, change orders,
• invoicing/payment activities).
• Coordinate completion of the Contract elements (BSA-MSA, Quality Agreement, PPS, SOW).
• Develop and maintain Master Project Plan (MPP) including accurate durations & accountabilities for all revenue¬ generating milestones throughout the scope of the program (contract sign, AD, Tech transfer, Clinical¬ Commercial Mfg, QA, QC, Release, Ship deliverables, Transfer in (materials/eqpt, methods, documentation), Transfer out (materials/eqpt, methods, documentation).
• Partner with the Sales Team to identify opportunities for additional work within the current contract.
• Partner with functional roles who oversee planning & execution to ensure that MPP revenue generating milestones are accurately translated into functional deliverables (e.g. Planning, QC-QA-PD-MFG readiness liasons).
• Understand the approach and details of pricing strategy and sure that all work requested beyond the SOW/contract is
• covered by change orders.
• When contract is signed, conduct cross-functional Program Kickoffs (Internal & Client):
• Assemble program core team, Educate the impacted organization about the client, the molecule(s), indication, scope of
• work
• Suppport and drive TT activites Define risks & mitigation actions (materials, equipment, long lead times, item specs,
• methods, etc.)

 

Governance/ Infrastructure:

• Confirm , Joint Steering Committees & project teams for all programs.
• Organize, lead and facilitate cross-functional project teams for each program. Provide a standard agenda and meeting summaries (discussion points, decisions, action-risk log). Implement a project team meeting cadence which enables 30 appropriate internal discussions and client engagement/communication.
• Assign and track specific functional accountabilities.
• Actively conduct risk management within and across programs.
• Ensure that MPP milestones are met.
• Escalate unresolved issues-risks-decisions to functional leaders and/or S&OP meetings (PM meetings) as appropriate to ensure that SLT knows the impact and potential intervention needed for resolution (including EHS-Quality Compliance, Finance, (PD), Mfg, lT/ENG).
• Track and report program performance (financial & delivery metrics and analysis, monthly reports, quarterly and annual leadership reviews, revenue change log, etc)
• Partner with the Finance Team to ensure accurate & timely completion of financial transactions (revenue adjustments/recognition, change orders, invoicing, pass through); maintain a change log which captures all financial activity per program; track & report program financial performance; identify, escalate & mitigate risks associated with monthly-quarterly-annual financial performance.
• Attend and actively participate in all Program Management department meetings.
• Lead and actively participate in program meetings (Program Delivery, Project Teams); Ensure that appropriate escalation occurs for unresolved issues & risks from project team forums.
• Drive team adherence to MPP milestones; monitor deliverables & ensure functional accountability; escalate to functional leaders as appropriate. Maintain and post a tracker of risks and action-who-when for functional deliverables. 
• Track, report delays Escalate delays /or revenue-QI impact).
• Attend and actively participate in S&OP meetings. Provide program updates & maintain alignment with the MPP. Work with Planning Team to look across programs and resolve conflicts.

Mindset/ Behaviors I Culture:

• Onoing prioritization, risk management & decision making, conflict resolution; Integrates customer requirement,scontract knowledge & input from functional experts to drive execution, decision making and team ownership/accountability.
• Focused on productivity, efficiency, simplification, right first time in program delivery (meeting customer requirements, cost reduction, growing business).
• Strong verbal, written & presentation communications (one-on-one, teams/group, internal & client); effectively engages, facilitates, influences & motivates business & technical audiences.
• Business acumen - working knowledge of client drug technologies and specialties, emotional intelligence, self¬awareness {navigating politically), professiona, able to influence/motivate others.
• Customer focus - builds & maintains collaborative working relationships with clients and internal colleagues and stakeholders; solicits and responds to client and internal stakeholder feedback; respectful of others across functions & levels; weekly updates at minimum, "office hours" for client questions, etc).
• Actively engaged, action-oriented, resilient, passionately neutral in leading programs & teams

 

Compliance:

• Keep current on cGMP, regulatory and quality requirements that impact FDBD manufacturing and client guidance

 

Minimum Requirements:

• Bachelors /Masters in relevant field (sciences, business, etc.) +8 years of relevant experience to include Project/program mgmt. skills

 

Preferred Requirements:

• Must be experienced in Project & Program management and have excellent and proven customer relationship management experience.
• Experience from CDMO organization is an asset. Must have strong business acumen skills, understanding of biologics manufacturing required

 

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).