UK ~ Reading
CMC Manufacturing Coordinator
Our growing and successful business comprises over 850 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.
We have an exciting opportunity for a CMC Co-ordinator to join our Reading site. As a CMC Co-ordinator you will be responsible for co-ordinating and implementing documentation activities required for pharmaceutical development activities and clinical manufacturing activities. You will also be responsible for the oversight and technical input of pre-Clinical Manufacturing activities which will lead to the authoring of accurate batch manufacturing and packaging records with associated labels and shipping protocols.
In this role you will work with Scientific & Technical Services, Formulation Development, Manufacturing Operations, Quality, Project Management and Materials Management teams to ensure that batch records, labels, raw materials, consumables, equipment and training packs are in place prior to any manufacture operations. You will also be responsible for checking data for IMPD submissions and training the manufacturing team in study specific batch record layout and completion.
This is a client facing role and you will be working with a multifunctional team, therefore you will be required to work and communicate effectively across different areas of the business. Being able to build strong working relationships and to collaborate with colleagues and clients is key to being successful in this position.
The ideal candidate will be educated to a minimum BSc or MSc. in Pharmaceutics, Pharmacy, or other related science subject with experience in drug development and/or manufacturing of IMP products, have knowledge of GMP procedures or been involved in clinical trial product management. Graduates will also be considered.
Previous formulation development, process development and/or cGMP manufacturing experience in the pharmaceutical industry would be an advantage. You must be an organised individual, have a high attention to detail and should be able to work towards strict and tight project deadlines.
The ability to juggle a wide range of tasks simultaneously and responding to client and internal demands is also essential for this role.
Applicants must have the right to work in the UK.
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.