Technical Manufacturing Lead

4 days ago


Nenagh, County Tipperary, Ireland Life Science Recruitment Ltd Full time

Life Science Recruitment Ltd are currently recruiting for a Technical Manufacturing Lead to join their team on a permanent basis. This is an excellent opportunity for a skilled professional to take on a challenging role and contribute to the growth of our client.

About the Role

We are looking for a highly experienced candidate with a strong background in pharmaceutical manufacturing. The ideal candidate will have expertise in multiple manufacturing process areas, including technology/product transfer, process scale-up, process optimisation, process validation, and routine manufacture.

The successful candidate will be responsible for leading and supporting the technology transfer of new and existing drug product manufacturing processes, ensuring timely completion of all technical transfer-related milestones. They will work closely with R&D to facilitate the introduction and scale-up of new products, as well as support due diligence efforts for all process, manufacturing, and validation activities.

  • Lead and support the technology transfer of new and existing drug product manufacturing processes.
  • Work with R&D to facilitate the introduction and scale-up of new products.
  • Support due diligence efforts for all process, manufacturing, and validation activities.
Key Responsibilities

The Technical Manufacturing Lead will be responsible for:

  • Reviewing and implementing changes identified from CPV, changes from cGMP standards requirements, process improvements or arising from corrective actions.
  • Preparing, reviewing, and approving relevant Standard Operating Procedures (SOPs) and other necessary GMP and GDP documents for activities related to manufacturing operations.
  • Conducting and supporting manufacturing process investigations to drive operational excellence and continuous improvement.
  • Evaluating new suppliers from a technical manufacturing perspective.
Requirements

To be successful in this role, you will need:

  • A B.Sc. in a science-related discipline (Chemistry, Engineering, Biotechnology, Pharmacy etc.).
  • No less than 10 years of relevant experience in a cGMP pharmaceutical manufacturing environment.
  • Experience in multiple manufacturing process areas, including technology/product transfer, process scale-up, process optimisation, process validation, and routine manufacture.


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