UK ~ Nottingham
Senior Manufacturing Scientist
Due to our continued growth and success, a great opportunity has arisen for a Senior Manufacturing Scientist to join our Manufacturing Operations team. In this role you will be responsible for the manufacture of Investigational Medicinal Products for all types of clinical studies performed at Quotient.
You will be required to work in a cleanroom environment, leading Clinical Trial Manufactures to Good Manufacturing Practice (GMP) standards. With direct input on production of batch manufacturing records, process optimisation and validation criteria and other key parameters.
You will also have to support in the development and validation of production methods for all types of clinical study performed and at all times being vigilant in both radiation and chemical safety measures to reduce the exposure of themselves and others to radiation or hazardous materials.
Other main tasks and responsibilities include:
- Line management of Manufacturing Technician role
- Supporting the PSM in organising and managing schedule/workload.
- Manufacture of pharmaceuticals to GMP standards Clinical Trial Manufacturing (CTM) and internal SOP standards (Development) and associated laboratory activities.
- Production of batch manufacturing records in line with third party and Quotient developed formulation and manufacturing processes.
- Actively mentoring junior members of staff and provide leadership with the GMP facility.
- Representation on study teams ensuring Manufacturing Operations roles and responsibilities are met and effectively communicated in accordance with SOPs of the Company.
- Provision of effective and efficient technical support in the scientific aspects of clinical studies (including: process method development, validation and transfer to GMP/ supporting development manufacturing).
- Ensuring that repetitive laboratory procedures are carried out in a reproducible manner with the minimum number of avoidable errors.
- Keeping detailed and accurate records of all work undertaken, ensuring that all records are clear, concise and legible at all times to enable for full repetition and traceability as per Good Documentation Practice (GDP).
- Performing day to day activities so as to ensure the smooth running of the Manufacturing Operations group, within the Pharmaceutical Operations Department of the Company, in line with written Protocols and /or Standard Operating Procedures of the company.
- Storage, use and disposal of Radioactive Isotopes in line with regulatory requirements and internal SOPs, to include liaising with Radiation Protection
- Supervisor (RPS) or nominated Deputy on any radiation protection issues that may arise.
- Working in a safe responsible manner at all times.
- Performing other duties as reasonably required.
The ideal candidate will be Degree level qualified in a science subject with relevant work experience desirable or have substantial work experience (GMP/GLP) in a similar type of work.