Summary: The Program Manager, with mentoring and support from the Head of Program Management and/or Associate Program Director or 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 program 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 Manager ensures the organization provides services in alignment with contractual commitments to the clients and the Company's vision/mission (strategy and compliance). The Program manager typically manages programs of shorter duration and/or fewer concurrent programs relative to a Associate Program Director.
- On board 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 FDBT Program Management business best practice (vision, mission, SWOT/SIPOC, 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 daily Tier 2 and Tier 3 meetings to support FDBT'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, 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 with support from Head of Program Management.
- Develop and maintain the Master Program 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 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, 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 Program 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 FDBT maintains best practices in the industry.
- All other duties as assigned.
Required Skills & Abilities:
- Excellent attention to detail with strong organizational and analytical skills.
- Computer proficiency required, including strong experience with Microsoft Office (Word, Excel, PowerPoint).
- 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.
- Ability to accurately complete required documentation.
- Good written and oral communication skills and the ability to effectively interact with all levels of the organization.
- Excellent time management skills with the ability to multi-task and self-manage activities.
- Demonstrated effective resource and Program planning/decision making.
- Demonstrated experience with problem solving and conflict resolution.
- Accountable for all aspects of Program Team's data support, entry, and ongoing data accuracy reporting.
- Knowledgeable in Quality systems, tools for process improvement and cGMP guidelines.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged sitting, standing, walking, bending, stooping and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Attendance is mandatory
- Bachelor's Degree with 4 years' relevant project experience.
- Relevant project management experience in a biotechnology or pharmaceutical development and manufacturing environment managing one or more projects of medium to high complexity.
- Degree in Business, Engineering, Microbiology, Chemistry, Biochemistry, or related field.
- 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.