Process Development Scientist

An exciting and challenging opportunity has arisen for a Process Development Scientist within a leading Contract Development and GMP Manufacturing Organisation in the field of Biologics and Regenerative Medicine.

This Edinburgh-based company operates at the leading edge of therapeutic discovery providing services for companies involved in European and US clinical trials.

The company are going through an expansion and as a result looking for a motivated and experienced Process Development Scientist to join their Development team. The positions main objective is to aid the development, GMP Translation and Technology Transfer (TT) of novel therapies for subsequent clinical application.  This role will include process design/development, scale up, assay design, the development of standard documentation for GMP processing, and the transfer to GMP manufacturing within the GMP Quality Management System.

The position will involve:

  • The development of manufacturing processes using the principals of quality by design.
  • Process development and improvement.
  • Process mapping and control point identification.
  • TT of client processes to GMP manufacturing and ensuring success through scientific / manufacturing expertise and clear communication.
  • Completion and design of documentation including standard forms, batch records, standard operating procedures (SOPs), experimental plans and reports in line with GMP requirements.
  • To collaborate with the GMP Quality Control (QC) Team to transfer new assays into routine practice and the GMP Production Team to transfer new procedures to the GMP cleanroom facility.
  • Devise, plan, execute, analyse and report development and TT studies.
  • To review new innovations in therapy processing including automation of technologies and process scale up.
  • To participate in the daily running of the CTD laboratories and maintain high standards of laboratory practice in all development activities.
  • Qualification of new techniques and training others in these techniques.
  • Researching new techniques/assays and liaising with experts in the field to introduce new assays to the CTD/QC departments.

Qualifications Required:

A PhD /honours degree in molecular biology, cell biology or similar.  Consideration will be given to individuals with relevant industrial or engineering experience.

Desirable Skills/Experience:

  • Experience of working with Bioreactor Technologies or engineering.
  • Experience of GMP Manufacturing and Technology Transfer
  • Experience with scalable processing technologies

All in all, the company are looking for someone to bring passion, drive and determination to this position and be an integral part in their growing success.

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