Skip to main content

Tech Transfer & Validation Manager

£55 - £85 per annum
23231/AN
Date Posted30 Aug 2019

This vacancy has now expired

Are you a Tech Transfer & Validation Manager with experience in bringing products from Clinical Development to Commercial Manufacturing? Are you looking to take the next step in your career and be part of an exciting new project? Then this position is exactly what you’re looking for.

This is your chance to work for a company that is a pioneer in gene and cell therapy focussing on long-term curative treatments. With vast investment being made into the organisation and new build projects on the horizon this is the ideal time to join the team and establish yourself as a key team member. They are led by an experienced executive team that are leading them to a bright and exciting future.

The Main Responsibilities are:
  • Develop Technical subject matter expertise in the Technical team and wider manufacturing operations.
  • Project Leadership/ Management arid formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, Launch and subsequent lifecycle
  • Responsible for Product Lifecycle Management activities including Process Validation of processes in line with ICHQ8-10.
  • Lead and/or provide technical support using established problem-solving techniques for investigations into Quality Events, Customer Complaints and IMC Provide technical recommendations, co­ ordinate and execute CAPA’s.
  • Management of Change Controls; Providing impact assessments as a Technical Functional, coordinating input and support from development if required. Lead/ Support and/or coordinate the action plans Include 8-12 main activities
Job Background:
  • Scientific Degree or equivalent, preferably with a higher qualification in a discipline related to bio­ pharmaceutical
  • Extensive industrial experience in Pharma/Bio within a GMP regulated
  • Demonstrated interpersonal skills with the ability to work cross-functionally both with internal and external partners.
  • Experience of transferring pharmaceutical products from Development into a GMP manufacturing environment and successfully gaining approval and launching new products commercially
  • Knowledge of the Regulatory compliance requirements within Europe, Japan and the
  • Demonstrated experience in the management of root cause analysis investigations utilising Lean/Six Sigma
  • Ability to manage, multiple, cross-functional projects to deliver against key project milestones and deadlines.
  • Excellent influencing skills and ability to establish effective working relationships with personnel at all levels.
  • Thorough working knowledge of ICH guidelines and current Good Manufacturing Practices


To view Quanta's privacy policy, please visit our website

Similar Jobs

Options: Contract
Location

Brussels

Description

We are looking for a Project Engineer to join a fantastic project on an initial 6-month contract with a very strong possibility to extend to 12 months or beyond. This role will be assisting with a

Options: Contract
Location

Limbricht

Description

Project Manager - The Netherlands - Cell and Gene Therapy  I am looking for a Senior Project Manager to work with my Global Pharmaceutical client's Cell and Gene Therapy facility.  The Project

Options: Permanent
Location

Maidenhead

Description

Are you looking for a Senior HR Advisor opportunity within a superb well established Pharmaceutical client? We have been selected as a preferred agent to search for an experienced Senior Advisor to

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.