Sr. Program Manager

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Job description

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:

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
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