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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, ShipDeliverables, 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:

• Develops and facilitates Joint Steering Committees and project teams for all programs

• Organizes, leads, and facilitates cross-functional project teams for each program (e.g., agenda and meeting summaries, discussion points, decisions, action-risk log)

• Implements a project team meeting cadence which enables appropriate internal discussions and client engagement/communication, while assigning and tracking specific functional accountabilities

• Actively conducts risk management within and across programs, while ensuring that MPP milestones are met (e.g., escalates unresolved issues-risksdecisions to functional leaders and/or SandOP meetings to ensure that Senior Leadership Team (SLT) knows the impact and potential intervention needed for resolution cross-functionally

• Tracks and reports program performance (e.g., financial and delivery metrics and analysis, monthly reports, quarterly and annual leadership reviews, revenue change log)

• Partners with the Finance Team and ensures accurate and timely completion of financial transactions (e.g., revenue adjustments/recognition, change orders, invoicing, pass through); maintains a change log which captures all financial activity per program; tracks and reports program financial performance; identifies, escalates, and mitigates risks associated with monthly-quarterly-annual financial performance

• Attends and actively participates in all PM department meetings

• Leads and actively participates in program meetings (Program Delivery, Project Teams) while ensuring that appropriate escalation occurs for unresolved issues and risks from project team forums

• Drives team adherence to MPP milestones; monitors deliverables and ensures functional accountability; escalates to functional leaders as appropriate; maintains and posts a tracker of risks and action-who-when for functional deliverables

• Tracks, reports delays, escalates delays / or revenue-QI impact

• Attends and actively participates in SandOP meetings, providing program updates and maintaining alignment with the MPP; works with Planning Team to look across programs and resolve conflicts

• Ongoing prioritization, risk management and decision making, conflict resolution; integrates customer requirements, contract knowledge and input from functional experts to drive execution, decision making and team ownership/accountability

• Focused on productivity, efficiency, simplification, right first time in program delivery (e.g., meeting customer requirements, cost reduction, growing business)

• Actively engaged, action-oriented, resilient, passionately neutral in leading programs and teams

• Performs other duties, as assigned

Knowledge and Skills

• Business acumen - working knowledge of client drug technologies and specialties, emotional intelligence, self-awareness {navigating politically),

• professional, able to influence/motivate others

• Customer focused - builds and 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 and levels; weekly updates at minimum, "office hours" for client questions, etc.)

• In-depth knowledge of biopharmaceutical manufacturing operations (DS / DP / FG) as well as CMC and regulatory aspects

• Experience with Customer Relationship Management

• Familiar with cGMP and FDA regulations

• Ability to lead, coach, develop, and motivate large cross-functional teams to achieve targeted results

• Problem solving and conflict resolution

• Knowledge of basic financial accounting

• Builds trust, respect, and collaboration across the organization

• Strong verbal and written communication skills and comfortably and clearly articulate issues across the organization

• Maintains discretion and confidentiality regarding sensitive information

Basic Requirements

• Bachelor’s degree in science or business field with 8+ years relevant experience (e.g., Project Management, Program Management) OR

• Master’s degree in science or business field with 6+ years of relevant experience

Preferred Requirements

• Master’s degree in science or business field with 8+ years of relevant experience

• Experience with Project/Program Management

• Experience with Customer Relationship Management

• Familiar with cGMP and FDA regulations

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes

Ability to discern audible cues. No X Yes

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes

Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to sit for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes

Ability to operate machinery and/or power tools. X No Yes

Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBNPNC@fujifilm.com _.

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.

Job Locations US-NC-Holly Springs

Posted Date 6 days ago (10/24/2024 11:09 AM)

Requisition ID 2024-28230

Category Program Management

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies