- Can work independently to meet key deliverables and milestones in addition to being able to effectively lead a matrix team.
- Builds & manages the Schedule of a Tech Transfer or complex Technical change; this includes task forecasting and ensuring controls are in place to anticipate adherence / slippage vs plan and ensure mitigating actions are in place, as required.
- Establishment and management of routine team meetings to facilitate plan updates, decision-making, problem solving, escalations e.g. resourcing gaps, mitigations vs non-adherence to plan.
- The scope of the role typically covers Drug Product transfers to and between 3rd party sites; may also include other relevant changes such as API source changes and process optimisation project leadership.
- Provides timely and thorough project update reports to customers, via the established cadence and process.
- Partners with all other functions responsible for progress of the change project, typically Pfizer Quality, External Supply Operations, Supply Chain, Artwork team, Regulatory, Receiving site CMO.
- Maintains oversight on Project budget; manages project risks i.e. leads the development of risk assessment and mitigations with the project team.
- Administrative activities for the project such as action/issue item tracking, generation of meeting minutes, coordination of focused working sessions between sending and receiving sites and follow up on actions.
- The Technical PM will typically have a basic level of expertise in Pharma Drug Product manufacturing, either Solid Oral Dosage or Sterile Injectables; expertise in both is preferential.
- understanding of the Pharma regulatory environment, would be highly advantageous.
- Minimum of a Degree in a Science or Engineering discipline with at least 5 years of direct project management experience.
- Project management skills to include experience of successful delivery of projects on schedule and to budget. Highly structured individual who can work with significant complexity
- Ability to articulate a problem and communicate effectively. Intuitive and focused on Achieving results.
- Well-developed interpersonal skills (leadership, integrity, team orientation, flexibility and creativity).
- Experience of working remotely in a matrixed & virtual environment.
- Self-driven and works independently to achieve milestones & goals.
- Knows when to lead and when to seek help
- Influential, Tenacious, Effective Communicator, Energetic & Highly Responsive
- Effective under pressure
- Risk aware, robust decision maker, analytical & critical thinker
- Can manage a budget
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Pharma Drug Product Technical Project Manager - County Kildare, Ireland - Cpl
Description
Cpl in partnership with our Client Pfizer Newbridge are looking for a
Pharma Drug Product Technical Project Manager
The Pharma Drug Product Technical Project Manager; primarily engaged with the management of drug product transfer(s), process robustness assessment & optimisations as well as process scale up to meet business needs; management complex technical changes such as API source change, packaging components changes and reformulations is also in scope. From time to time, the Technical PM may also be required to lead a complex investigation, managing a team of SMEs.
POSITION SUMMARY:
The Pfizer Global Technology & Engineering (GTE) Team provides Project & Program Leadership on complex change projects in support of Pfizer's External Supply (ES) Business Unit. The scope covered is typically product/process transfers from 1 manufacturing location to another, as well as source change of APIs and process optimisation projects. The site where the changes are based (Tech Transfer receiving, API change qualification or DP process optimisation) is typically a non-Pfizer site i.e. a 3rd party manufacturing location (CMO).
The Project Manager leads a multi-functional matrix team of people from across Pfizer and the CMO.
POSITION RESPONSIBILITIES:
ORGANIZATIONAL RELATIONSHIPS:
External Supply Operational Managers, Supply Chain, Procurement, QO (ES Quality), Regulatory, GTE SME teams, Global artwork teams
RESOURCES MANAGED:
None directly, but will coordinate a matrix team.
EDUCATION, EXPERIENCE, TECHNICAL SKILLS & GENERAL COMPETENCIES:
"Hands-on" experience of pharmaceutical manufacturing unit processes is essential;
PHYSICAL POSITION REQUIREMENTS:
The role is primarily office-based and virtual. Not expected to sit at a Pfizer site location. Travel to external meetings and CMOs may be required up to 20% max.
This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent.
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