- 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.
- Lead the project 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.
- 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 project 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 project 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.
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.
- 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.
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 standing, some 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 preferably in Engineering, Microbiology, Chemistry, Biochemistry, Business, or related field, and
- 8 years’ relevant project management experience.
- 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