Senior Scientist, Production - Diagnostics/ Life Sciences
Hours: Days (Monday to Friday)
Our Client, a Diagnostics/Life Sciences company - is looking to recruit for an experienced Scientist and become a vital part of the production and laboratory team at their HQ.
As part of the team, manufacture in vitro diagnostic kits, including PCR, next generations sequencing and immunoassays to high quality GMP standards. You will be responsible for the control of raw materials, liquid dispensing, operation of the freeze driers and completion of finished kits. You will add value through the continuous improvement of the Clients ISO13485 quality system and FDA compliant processes. You will also be responsible for leading manufacturing processes and ensuring that members of the production team have the training and resources required to adequately complete their duties.
- Lead and supervise manufacturing processes, day to day line management of the manufacturing scientists.
- Ensuring manufacturing scientists have the necessary/required training for carrying out procedures, and providing guidance to ensure that they can carry out their duties to the highest of standards.
- Manufacturing of the Clients custom client IVD product lines.
- Completion and maintenance of manufacturing records to ensure compliance with Regulatory bodies.
- Responsibility for ensuring traceability of all products from raw materials to finished product. Acceptance of raw materials and ensuring that they meet Goods Inward Specifications.
- Ensuring that the manufacturing laboratory and all equipment is fit for use.
- Assist in the transfer to manufacturing of clients IVD product lines and the generation and design of new production documentation.
- Liaising with clients as to their requirements and responding to client queries.
- Ensuring that all manufacturing projects are set on Basecamp and responsible for ensuring that relevant paperwork is ready for upcoming production runs.
- Completing stock takes, ordering, and allocating stock items for upcoming production runs as well as ensuring general stock is kept above a minimum level.
- Responsible for driving continuous improvement within manufacturing processes, either through updates to the batch manufacturing records or completing validation on production equipment.
- Play an active role in the assay development process, working closely with the Head of Technical Services and team, and carry out tasks related to product development independently if required.
- Will hold a Degree in a relevant Scientific discipline
- Previous scientific production (or similar); ideally with lab combined experience
- Will have worked to GMP or ISO 13485 standards
- A strong eye for detail and able to problem solve on demand
- Strong interpersonal skills, as such able to communicate with numerous stakeholders