Associate Director, Program Manager

Overview:

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

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

This will be the largest end-to-end cell culture CDMO provider in North America.

The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US:

About This Role

The APD handles an average load of 1-3 larger and more strategic programs or may have oversight of the set of programs for one DSM suite. This role receives coaching and guidance from the Head of Program Management and peers within the team. Other functions of this role can extend to supporting the initial customer interface and the Commercial organization 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 is in place.

What You’ll Do

Execution/Delivery:

• Ensures the strategic programs and oversight for a set of programs for one Drug Substance Manufacturing suite
• 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
• When contract is signed, conduct cross-functional Program Kickoffs (Internal and Client)
• Assembles program core team, educate the impacted organization about the client, the molecule(s), indication, SOW
• Supports and drives TT activities Define 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 risks-decisions 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
• Coordinates discussions at a global level when requires to support customers who have multi-site presence to ensure alignment and a OneFDB voice
• 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 FDBN Job Description – M4 Template Revised: January 2024 Page 2 of 3
• 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
• Engages in 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
• Maintains a mindset of actively engaging, action-oriented, resilient, passionately neutral in leading programs and teams
• Performs other duties, as assigned

• Focused on productivity, efficiency, simplification, right first time in program delivery (e.g., meeting customer requirements, cost reduction, growing business)
• In-depth knowledge of biopharmaceutical manufacturing operations (DS / DP / FG) as well as CMC and regulatory aspects
• Ability to lead, coach, develop, and motivate large cross-functional teams to achieve targeted results
• 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.)
• 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

• Bachelor’s degree in relevant field (sciences, business, etc.) with 8+ years of relevant experience to include Project/Program Management skills OR
• Masters in relevant field (sciences, business, etc.) with 6+ years of relevant experience to include Project/Program Management skills
• Must be experienced in Project & Program management
• Proven Customer Relationship Management experience
• Familiar with cGMP and FDA regulations

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

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

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

If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.