Technical Project Manager - Walsh Employment : Job Details

Our client is an outstanding and innovative European pharmaceutical company committed to enhancing patient outcomes by providing essential medications. The business licenses and distributes a range of treatments for CNS disorders, critical care, and other conditions, operating both independently and through strategic partnerships in over 60 countries globally. We are now looking for a Technical Project Manager to join their busy, growing and highly successful team.

Technical Project Manager

London - hybrid role with working from home 4 days per week.

£55-60K plus excellent benefits package.

To be successful in this role:

You will be a confident Technical Project Manager with a background in pharmaceutical Technical Transfer. You will have a proven ability to work across internal functions and to operate effectively with Contract Manufacturing Organizations (CMOs), and will have a strong analytical, formulation or process background, excellent communication skills, and the ability to work collaboratively with various teams. Other requirements for this role include:

• Understanding and experience of established processes of a product lifecycle; experience across all stages of Technical Transfer and in successfully delivering the transfer of pharmaceutical products, management of third-party contract manufacturing vendors
• Experience in APIs, oral solid dose and/or sterile pharmaceutical products, packaging transfer activity experience useful but not essential
• Experience in manufacturing and/or R&D preferred but not essential, knowledge of analytical requirements associated with Tech Transfers and/or pharmaceutical packaging processes is useful

Other skills for this role include:

• Remote management; technical contract review and negotiation; accountability; working to deadlines; independent worker; decision making; effective communication with cross functional teams (PV, QA, Regulatory, Supply Chain, Strategic Projects); problem solving; delivery skills; ability to influence and take holistic views across product lifecycle; identifying opportunities and risks; troubleshooting day to day issues with virtual supply chain; broad technical knowledge coupled with commercial acumen & relationship management skills; due diligence for acquisitions and subsequent integrations

Job role and responsibilities:

As a Technical Project Manager, you will be responsible for the coordination and delivery of technical projects, predominantly in support of Scientific Affairs, Strategic Projects and Corporate Development. Responsibilities for this role include:

• Maintain high standards of ethics, and support the company in its efforts to have a pioneering approach to environmental, social and governance (ESG)
• Follow, promote and enforce relevant SOPs, Work Practices, and Company policies and procedures
• Coordination, scoping and costing of Technology Transfer activities for API and finished products
• Planning and execution of technical projects using a set of agreed "project tools" including preparation of project plans and hands on participation in the practical delivery of the plan and project deliverables
• Technical ownership / stewardship of Commercial Products manufactured API and finished products processes (manufacturing, quality control, packaging and release) with respect to the planning, review and approval (via change control) and implementation of changes in conjunction with CMOs
• Be the point of contact for technical investigations (deviations) and remediation (CAPAs)
• Work cross functionally to identify, evaluate and manage continuous improvement projects (process enhancements which provide a measurable improvement in Quality or productivity)
• Due diligence processes as required and as led by the team by providing technical input
• Support the integration of new product acquisitions into the Quality, Regulatory and Technical systems and processes
• Technical evaluation of stability data and manufacturing processes using statistical process control / process capability techniques, so as to ensure data and processes are in control
• Ensuring the Quality, Regulatory and Technical departments are aware of all current and future changes to European and ROW technical and quality legislation
• Lead assessments of the impact and actions necessary to ensure compliance with any draft legislation