- Participate the planning and execution of programs in alignment with the FDBT Program Management business best practice (vision, mission, SWOT/SIPOC, strategy-goals-objectives).
- Ensure data from Program Directors is complete for salesforce, milestones, resource sheets and other business databases to support business planning meetings as assigned.
- Participates in client meetings, keeping meeting minutes and coordinating presentation of meeting materials
- Maintain PMO version control and best practices.
- Translates technical information into project summaries
- Support Program Directors in providing Head of Program Management project updates
- Effectively understands the project life-cycle
- Proactively works with Program Directors to ensure the team is meeting and exceeding expected project deadlines and delivering project milestones
- Coordinates client teleconferences and on site F2F meetings as needed, in support of Program Directors
- Actively participates and lead when assigned weekly project discussion meetings to review project milestones and deliverables
- Communicates with cross-functional internal teams and coordinates internal team meetings to ensure timely delivery of project milestones
- Maintains confidentiality in all business matters
- Interact with site Tier process and provide appropriate data for escalation to Head of Program Management to support decision making as appropriate.
- Lead 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 the program team, the site leadership teams are appropriately informed.
- Lead up to 3 cell banking, viral banking and process development projects.
- Attend and lead daily Tier 2 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.).
- Support the Development 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 Project Directors 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.
- 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.
- Support the authoring Scopes of Work, Change Orders, Cost Models, and Confidentiality Agreements.
- 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).
- Strong 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.
- Understand the need for effective resource and project planning/decision making.
- Demonstrated experience with problem solving and conflict resolution.
- 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, 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.
Minimum Required Qualifications:
- Bachelor’s Degree preferably in Business, Engineering, Microbiology, Chemistry, Biochemistry, or related field, and
- Five (5) years of experience in a fast-paced environment, preferably in the biotechnology, pharmaceutical, laboratory, healthcare or related industry.
- At least one (1) year of experience leading cross functional teams in support of organizational programs.
- PMP Certification