UK ~ Nottingham
Our growing and successful business comprises over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Due to our continued growth and success a great opportunity has arisen for a 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 aid 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.
You will also have to transfer these methods successfully into Good Manufacturing Practice (GMP) Clinical Trial Manufacturing, with direct input on production of batch manufacturing records, process optimisation and validation criteria and other key parameters.
Other main tasks and responsibilities include:
- 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.
- Representation on study teams ensuring Manufacturing Operations roles and responsibilities are met and effectively communicated in accordance with SOPs of the Company.
- Responsibility for performing study specific batch manufacturing record training on studies whereby acting as Responsible Manufacturing Scientist.
- 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).
- Plan and complete weekly workloads based on the schedule of CTMs and Development activities.
- 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.
Applicants must have the right to work in the UK upon being offered employement.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.