Director, Program Management

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large. The Program Director will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to project delivery including technology transfer, and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure. The Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).

Job Title: Director, Program Management

Reports to: Head of Program Management

Employment Type: Full-Time

FLSA Status: Exempt

Summary: The Program Director will be responsible for the planning and delivery of programs from the point of contract signature (Scope of Work/Letter of Intent/Contract) to project delivery including technology transfer, and taking a product/process from execution of a client commercial agreement or memorandum of understanding through process development and early stage clinical supply through program closure. The Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance).

Essential Functions:

• Onboard new customer programs with the Sales Team to transition to become the primary liaison for program planning and execution upon confirmation that a Verbal Win/ Letter of Intent has been reached.
• Lead the planning and execution of programs in alignment with the FDBC-Program Management business best practice (vision, mission, SWOT/SIPOC, strategy-goals-objectives).
• Oversee the general day-to-day execution of project activities and planning to ensure on time completion of project tasks and deliverables as scheduled.
• Identify program delivery risks and mitigations and ensure program team, site leadership team, and customer are appropriately informed.
• Direct and mentor at least one Program Coordinator to accomplish goals agreed upon with the Head of Program Management, consistent with PMO and best practice procedures, to delight our customers.
• Process annual reviews, provide goals, guide and discipline direct reports.
• Lead the program team in Stage Gate reviews as part of the program life cycle to communicate program readiness and risk profile to the site leadership team.
• Establish daily Tier meetings to support communication structure for escalations and feedback in program risk items.
• Serve as the lead with the functional areas to ensure the SOW elements are accurate, complete, and organized based on revenue-generating segments of work.
• Ensure financial activities and program milestones are aligned (SOW, PPS, revenue recognition milestones, change orders, invoicing/payment activities, etc.).
• Ensure all Contract elements (BSA-MSA, Quality Agreement, Price and Payment Schedule, SOW) are completed.
• Develop and maintain the Master Project Plan (MPP) including ensuring durations and accountabilities for all revenue generating milestones are accurate through the scope of the program (contract sign, PD US/DS, AD, Tech transfer, Clinical-Commercial Manufacturing, QA, QC, Release, Ship Deliverables, Transfer in and Transfer out).
• Collaborate with the Sales Team to identify additional opportunities for additional work within the current contract.
• Partner with functional teams (QC, QA, PD, Manufacturing, etc.) to ensure that MPP revenue generating milestones are accurately translated into functional deliverables and all action items are completed per the committed timeline.
• Work closely with Process Development, Manufacturing, Engineering, Quality Control and Quality Assurance to reduce time to clinic or market, improve ease of manufacturing, and reduce costs when compared with existing platform products while achieving and maintaining full compliance (cGMP, Safety and Environmental).
• Accurately define timelines and resource requirements for the assigned projects.
• Maintain project documentation (change orders, project reports, timelines, etc.).
• Manage and lead program team meetings including issuance of agenda, action items, meeting minutes, client communications, etc.
• Communicate project updates to the Executive Team at predefined milestones and at defined intervals.

• Organize and conduct program team and Joint Steering team meetings with external clients including agenda, meeting notes, action items, and follow-up of action items.
• Track and report program performance (financial, delivery metrics and analysis, monthly reports, quarterly and annual leadership reviews, revenue change log, etc.); ensure accurate and timely completion of financial transactions (revenue adjustments/recognition, change orders, invoicing, pass through) and maintain a change log capturing all financial activity per program.
• Responsible for authoring Scopes of Work, Change Orders, Cost Models, and Confidentiality Agreements. Responsible for approving project purchase orders. Responsible for forecasting revenue and reviewing/approving monthly customer invoices.
• Continuous improvement of existing systems as well as implementation of new Program Management systems, including training of employees to ensure FDBC maintains best practices in the industry.
• All other duties as assigned.

Required Skills & Abilities:

• Proven and strong leadership skills.
• Experience in a world class process development or manufacturing environment utilizing best practice methodologies such as Lean Manufacturing, Six Sigma, 5S, QbD, DFM, etc.
• Experience in Technology Transfer and Process Development.
• Ability to hire, train, and develop direct reports to grow within the organization.
• Ability to provide disciplinary action following the guidance of Human Resources.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint and other analytical applications.
• Excellent communication (written and oral) and presentation skills, effectively engaging, facilitating, influencing, and motivating business and technical audiences.
• Ability to illustrate complex issues, evaluate them critically, and navigate a goal oriented process.
• Excellent problem solving and conflict resolution skills and the ability to identify, assess, and resolve business problems, issues, risks and facilitate issue resolution and risk mitigation.
• Demonstrated ability to build and maintain collaborative working relationships with clients and internal colleagues and stakeholders in a matrixed team environment.
• Ongoing prioritization, risk management and decision making, conflict resolution; integrating 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 (meeting customer requirements, cost reduction, growing business).
• Identify, recommend and implement opportunities for streamlining team and business processes to reduce costs and improve efficiencies.
• Partner with stakeholders to ensure effective and timely completion of deliverables and to ensure the team achieves and maintains a high level of sustainable performance.
• Active ownership of problems of diverse technical and business scope where the analysis requires in-depth evaluation and research of competing options.

Qualifications:

• Bachelor’s degree; preferably in Engineering, Microbiology, Chemistry, Biochemistry, Business, or related field; AND
• 8 years’ relevant project management experience; AND
• At least 1 year of leadership or supervisory experience.

Preferred Qualifications:

• Relevant project management experience in a biotechnology or pharmaceutical development and manufacturing environment managing a portfolio of multiple complex programs.
• MBA or Master’s degree.
• Strong experience with quality systems.
• Experience in a cGMP facility or working with FDA regulations.
• Certifications in Project/Risk Management (PMI-PMP, PMI-RMP) or Lean Six Sigma and demonstrated practical experience.
• Previous Accounting/Finance/Budgeting experience

Salary and Benefits:

• $160,000 to 200,000 per year, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

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.