Pharma Drug Product Technical Project Manager

PharmEng Technology is committed to attracting and retaining world-class employees valued for their contributions to achieving business objectives. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion, and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Technical Project Manager to join our team.

Job Summary:

Pharma Drug Product Technical Project Manager; primarily engaged with the management of Drug Product transfer(s); management of process optimization projects is also in scope.

The scope covered is typically product/process transfers from one manufacturing location to another, as well as source change of APIs and process optimization projects. The site where the changes are based (Tech Transfer receiving, API change qualification, or DP process optimization) is typically a 3rd party manufacturing location (CMO). The Project Manager leads a multi-functional matrix team of people from across the organization and the CMO.

Key Responsibilities:

• Can work independently to meet key deliverables and milestones in addition to being able to effectively lead a matrix team.
• Builds & manages the Schedule; 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, and 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 optimization project leadership.
• Provides timely and thorough project update reports to customers, via the established cadence and process.
• Partners with all other functions responsible for the progress of the change project, typically Quality, External Supply Operations, Supply Chain, Artwork team, Regulatory, and 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.

Qualifications:

EDUCATION AND EXPERIENCE

• Strong knowledge of pharmaceutical manufacturing unit processes; understanding of the Pharma regulatory environment, while not essential, would be advantageous.
• Minimum of a Degree in a Science or Engineering discipline with at least 5 years of project management experience. Project management skills to include experience of successful delivery of projects on schedule and to budget.
• Excellent written and verbal communication skills. 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.

TECHNICAL SKILLS & COMPETENCIES

• Project Management capabilities
• Highly structured individual who can work with significant complexity and in the “grey space”.
• Strong knowledge of Pharmaceutical manufacturing essential.
• Self-driven and works independently to achieve milestones & goals.
• Seeks help with scope when appropriate.

PHYSICAL POSITION REQUIREMENTS

The role is primarily office-based and virtual. Not expected to sit at a site location. Travel to external meetings and CMOs may be required.