Associate Director, Program Management (On-Site In College Station, Tx)

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

The Associate Director, Program Management, with mentoring and support from the Head of Program Management and/or a 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 Associate Program Director ensures the organization provides services in alignment with contractual commitments to the clients and the Company’s vision/mission (strategy and compliance). The Associate Program Director typically manages programs of shorter duration and/or fewer concurrent programs relative to a Program Director.

Reports to Director, Program Management

Work Location College Station, TX

Travel As needed

Primary Responsibilities:

• Manage and lead program team meetings, including issuance of agenda, action items, meeting minutes, client communications, etc.
• Collaborate with the Sales Team to identify additional opportunities for additional work within the current contract.
• 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.
• 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.
• Identify program delivery risks and mitigations and ensure the program team, the site leadership team, and the customer are appropriately informed.
• 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.
• 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).
• 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.
• Ensure financial activities and program milestones are aligned (SOW, PPS, revenue recognition milestones, change orders, invoicing/payment activities, etc.).
• 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.
• Lead the planning and execution of programs in alignment with the FDBT Program Management business best practice (vision, mission, SWOT/SIPOC, strategy-goals-objectives).
• 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).
• 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.
• Attend and lead daily Tier 2 and Tier 3 meetings to support FDBT’s communication structure for escalations and feedback in program risk items.
• Maintain program documentation (change orders, program reports, timelines, etc.).
• 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.
• Oversee the general day-to-day execution of program activities and planning to ensure on-time completion of program tasks and deliverables as scheduled.
• 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.
• Accurately define timelines and resource requirements for the assigned programs.

Qualifications:

• 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 effective resource and program planning/decision making.
• Excellent attention to detail with strong organizational and analytical skills.
• Ability to accurately complete required documentation.
• Experience in a cGMP facility or working with FDA regulations.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.
• 6+ year’s of relevant project management experience.
• Previous Accounting/Finance/Budgeting experience preferred.
• Bachelor’s Degree preferably in Business, Engineering, Microbiology, Chemistry, Biochemistry, or related field; and
• Knowledgeable in Quality systems, tools for process improvement and cGMP guidelines.
• Demonstrated experience with problem solving and conflict resolution.
• Computer proficiency required, including strong experience with Microsoft Office (Word, Excel, PowerPoint).
• MBA or Master’s degree preferred.
• Accountable for all aspects of program Team’s data support, entry, and ongoing data accuracy reporting.
• Good written and oral communication skills and the ability to effectively interact with all levels of the organization.
• Relevant project management experience in a biotechnology or pharmaceutical development and manufacturing environment managing one or more projects of medium to high complexity preferred.
• Certifications in Project/Risk Management or Lean Six Sigma preferred.
• Excellent time management skills with the ability to multi-task and self-manage activities.