Senior Pharmaceutical Project Coordinator

2 weeks ago

Islington, Greater London, United Kingdom Walsh Employment Ltd Full time
Technical Project Manager

We are seeking a highly skilled Technical Project Manager to join our team at Walsh Employment Ltd. As a key member of our team, you will be responsible for coordinating and delivering technical projects in support of Scientific Affairs, Strategic Projects, and Corporate Development.

Key Responsibilities:
  • Maintain high standards of ethics and support the company's 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
  • Coordinate, scope, and cost Technology Transfer activities for API and finished products
  • Plan and execute 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
  • Take technical ownership and stewardship of Commercial Products manufactured API and finished products processes, including planning, review, and approval (via change control) and implementation of changes in conjunction with Contract Manufacturing Organizations (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 that provide a measurable improvement in Quality or productivity)
  • Provide technical input for due diligence processes as required and led by the team
  • Support the integration of new product acquisitions into the Quality, Regulatory, and Technical systems and processes
  • Conduct technical evaluations of stability data and manufacturing processes using statistical process control/process capability techniques to ensure data and processes are in control
  • Ensure 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

Requirements:

  • Confident Technical Project Manager with a background in pharmaceutical Technical Transfer
  • Proven ability to work across internal functions and operate effectively with Contract Manufacturing Organizations (CMOs)
  • Strong analytical, formulation, or process background, excellent communication skills, and the ability to work collaboratively with various teams
  • 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

What We Offer:

  • Hybrid role with working from home 4 days per week
  • £55-60K plus excellent benefits package

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