We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a Program Manager to work at our RTP, NC location. The successful candidate will be accountable for the planning & delivery of programs from the point of contract signature (Scope of Work / Letter of Intent / Contract) through program closure. They will ensure we provide services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). The Program Manager typically handles an average load of 2-4 programs receives and receives coaching & guidance from the Head of Program Management.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Lead the planning and execution of programs in alignment with FDB-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.
- After the Sales Team completes the initial draft Scope of Work (SOW) & Price/Payment Schedule (PPS), the CPL 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, PD US/DS, 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 director, 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.
- Governance / Infrastructure:
- Confirm SLT sponsors, 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 appropriate internal discussions and client engagement/communication. Assign and track specific functional accountabilities.
- Actively conduct risk management within and across programs
- Track and report program performance
- Attend and actively participate in all monthly Financial meetings; partner with the Finance Team to ensure accurate & timely completion of financial transactions
- Report to functional leaders & tier 3 as appropriate. Maintain and post a tracker of risks and action-who-when for functional deliverables.
- Track, report & pareto delays
- Attend and actively participate in Supply Planning meetings. Provide program updates & maintain alignment with the MPP. Work with Planning Team to look across programs and resolve conflicts.
Mindset / Behaviors / Culture:
- Ongoing prioritization, risk management & decision making, conflict resolution; integrates customer requirements, contract 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), professional, 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
- Recognizes & thanks individuals and teams for jobs well done.
- BS in chemistry, biochemistry, engineering or microbiology
- MBA preferred.
- Certifications preferred
- Project/Risk Management certification (PMI-PMP, PMI-RMP) plus demonstrated practical experience.
- Lean Six Sigma certification & demonstration of business impact preferred.
- 5+ years of demonstrated experience:
- Managing a portfolio of 4-6 programs.
- Customer Relationship Management.
- cGMP & FDA regulations.
- Leading-coaching-developing-motivating large cross-functional teams to achieve targeted results.
- Problem solving & conflict resolution.
- Knowledge of basic financial accounting.
- Building trust, respect, and collaboration across the organization.
- SharePoint & MS Office capability
- Strong verbal and written communication skills and comfortably and clearly articulate issues across the organization.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU 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.
FDBU 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.