Program Management - Associate Director
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: May 14, 2022
Overview Summary: - The Associate Program Director, 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. External US
- 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
- 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
- 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.
- 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
- 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
- Accurately define timelines and resource requirements for the
- Maintain program documentation (change orders, program reports,
- Manage and lead program team meetings, including issuance of
agenda, action items, meeting minutes, client communications,
- 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
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
- All other duties as assigned.Required Skills & Abilities:
- Excellent attention to detail with strong organizational and
- 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
- 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
- Demonstrated experience with problem solving and conflict
- 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 mandatoryQualifications:
- Bachelor's Degree preferably in Business, Engineering,
Microbiology, Chemistry, Biochemistry, or related field; and
- 6 years' relevant project management experience. -Preferred
- Relevant project management experience in a 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
- MBA or Master's degree
- Experience in a cGMP facility or working with FDA
- Previous Accounting/Finance/Budgeting experience.We are an
equal opportunity and affirmative action employer. All qualified
applicants will receive consideration without regard to race,
color, national origin, sex, gender identity, sexual orientation,
religion, disability, protected veteran status or any other
characteristic protected by applicable federal, state, or local
law. -If an accommodation to the application process is needed,
please email FDBTHR@fujifilm.com or call 979-431-3528. -
Keywords: FDBT - FUJIFILM Diosynth, College Station , Program Management - Associate Director, Executive , College Station, Texas
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