Campus Pride Jobs

Overview

The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what FDB call Genki.

External US

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 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 Companys vision/mission (strategy and compliance).

Reports to Head of Program Management

Work Location College Station, TX

Travel As needed

Primary Responsibilities:

• 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 FDBT-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.
• Attend and lead daily Tier 2 and Tier 3 meetings to support FDBTs 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 FDBT maintains best practices in the industry.
• All other duties as assigned.

Qualifications:

Bachelors degree; preferably in Engineering, Microbiology, Chemistry, Biochemistry, Business, or related field required.

8+ years relevant project management experience required.

1+ year of leadership or supervisory experience required.

Relevant project management experience in a biotechnology or pharmaceutical development and manufacturing environment managing a portfolio of multiple complex programs preferred.

MBA or Masters degree preferred.

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 preferred.

Previous Accounting/Finance/Budgeting experience preferred.

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