Manufacturing Scientist CMC
Our client is a major Contract Research and Development Organisation (CRDO), providing the pharmaceutical industry with a comprehensive range of services.
They are focused on Process Research, Development, Scale-Up and small scale manufacturing, including bioanalysis, DMPK, regulatory and consulting services, covering drug candidates in Development and launched to the Market.
The key tasks of the position are:
- 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.
- 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.
Based: North East England
Salary: Negotiable Basic + Benefits
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