Associate Director, Program Management

Essential Functions

• On board new customer programs with the Commercial 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 F L BT Program Management business best practice (vision, mission, strategy-goals-objectives).
• Oversee the general day-to-day execution of program activities and planning to ensure on-time completion of program tasks and deliverables as scheduled.
• Identify program delivery risks and mitigations and ensure the program team, the site leadership team, and the customer are appropriately informed.
• 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.
• Attend and lead regular Tier meetings to support F L BT’s 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, revenue recognition milestones, change orders, invoicing/payment activities, etc.).
• Ensure all Contract elements (MSA, Quality Agreement, Price and Payment Schedule, SOW etc ) are completed.
• Develop and maintain a program schedule including ensuring durations and accountabilities for all revenue generating milestones are accurate through the scope of the program (contract signature, PD US/DS, AD, Tech Transfer, Clinical-Commercial Manufacturing, QA, QC, Release, Ship Deliverables, Transfer in and Transfer out).
• Collaborate with the Commercial Team to identify additional opportunities for additional work within the current contract.
• Partner with functional teams (QC, QA, PD, Manufacturing, etc.) to ensure that program revenue generating milestones are accurately translated into functional deliverables and all action items are completed per the committed timeline.
• Work closely with Process Development, Operations, 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 programs.
• Maintain program documentation (change orders, program reports, timelines, etc.).
• Manage and lead program team meetings, including issuance of agenda, action items, meeting minutes, client communications, etc.
• Communicate program updates to the Leadership 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).
• 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 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 F LB T maintains best practices in the industry.
• Expected to lead multiple programs in parallel in service of large, multi-program clients as well as manage one to two individual employees as part of role responsibilities.

Requirements

• Bachelor’s Degree preferably in Business, Engineering, Microbiology, Chemistry, Biochemistry, or related field; and 10 years’ relevant project management experience.
• 5 years of people leadership experience.
• Relevant project management experience in biotechnology or pharmaceutical development and manufacturing environment managing one or more projects of medium to high complexity.
• Certifications in Project/Risk Management or Lean Six Sigma.
• MBA or Master’s degree.
• Experience in a cGMP facility or working with FDA regulations.
• Previous Accounting/Finance/Budgeting experience.