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Manufacturing Scientists - CMC

Date Posted: 15/8/2017
Application Close: 31/12/2017
Location: Arcinova - Alnwick
Description:

The key tasks of the position are: 

  • As guided/requested, manufacture and package oral and intravenous clinical products. Prepare and complete documentation associated with the manufacture and supply of clinical products.
  • Dispense APIs, excipients, drug products, IMPs and packaging materials for clinical use and maintain GMP stocks as required.
  • Participate in, the cleaning, maintenance and upkeep of the GMP manufacturing facility, utilities and equipment.
  • Record work in compliance with relevant regulatory requirements, internal policies/procedures and where appropriate, client requirements.
  • As guided/requested, participate in process development studies or the manufacture of non-clinical batches to assist in the development of clinical formulations or the transfer of developed formulations into the GMP facility.
  • Participate in the upkeep of the GMP material inventory including ordering, goods receipt, storage and stock control; liaising as appropriate with the QC and microbiology teams and Purchasing Officer.

The successful candidate will be educated to a minimum of BSc(Hons) (or equivalent), in a relevant scientific discipline, eg Pharmaceutical Sciences.  Experience in the manufacture of clinical formulations, working in a GMP regulated facility/manner and knowledge of the drug development process would be advantageous.  You should be able to demonstrate good interpersonal and communication skills, both written and oral, and must be self-motivated.  A high level of personal integrity and commitment is essential, as is a flexible approach to new work challenges.