Analytical Method Transfer Expert

JOB DESCRIPTION

Job title: Technical Project Executive

Reporting to: Technical Project Manager

Department: Scientific Affairs

The Role:

Walker Cole International are looking for a Analytical Method Transfer Expert who will be responsible for the delivery of technical projects, predominantly in support of Scientific Affairs, Strategic Projects and Corporate Development. The role requires the proven ability to work across internal functions and to operate effectively with Contract Manufacturing Organizations (CMOs). The incumbent will have a strong analytical, formulation or process background, excellent communication skills, and the ability to work collaboratively with various teams.

Core Tasks & Responsibilities:

• Responsible for the coordination, scoping and costing of Technology Transfer activities for API and finished products.
• Responsible for the 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.
• To support the 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.
• To be the point of contact for technical investigations (deviations) and remediation (CAPAs).
• To work cross functionally within the company (predominantly Corporate Development and Strategic Projects) to identify, evaluate and manage continuous improvement projects (process enhancements which provide a measurable improvement in Quality or productivity).
• To be involved in due diligence processes as required and as lead by the team by providing technical input. To support the integration of new product acquisitions into the Quality, Regulatory and Technical systems and processes.
• To be responsible for the 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.
• Responsible for ensuring the Quality, Regulatory and Technical departments are aware of all current and future changes to European and ROW technical and quality legislation.
• To lead assessments of the impact and actions necessary to ensure that the business would be compliant with any draft legislation.
• Undertake other tasks and duties as delegated from time to time from Senior Management