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Senior Manufacturing Trials Team Leader

Worcestershire   •  Negotiable  •  Permanent, Full time


Senior Manufacturing Trials Team Leader

Permanent position - Worcestershire

Salary up to £45,000 dependant on experience

My client is a successful multi-national biotechnology company looking to recruit a senior scientist to aid in the development of multiplex ELISA assays for commercial IVD use utilising full automation. This role will be to co-manage the technical transfer of solid phase panel immunoassays, from development through to production, including validation and analytical trials.

Essential Functions:
This position involves working in both a hands on and a management role to manufacture, test and validate a range of solid phase panel immunoassays. This will primarily involve you working in conjunction with the manufacturing team leader, the R&D team leaders, potential partner companies and other senior managers to oversee:
The successful technical transfer and manufacturing scale-up of assay components, which work in a multiplex format, from development into production.
The procurement and control of all the required raw materials.
The generation of all manufacturing and process validation documentation
The manufacturing and quality control testing (using automated immunoassay instruments) of components and final kits.

You will be directly responsible for
The writing of all analytical trial protocols and validated spreadsheets.
Generating the data to support and validate the final assay's performance.
Ensuring all materials are in place to allow the clinical trials to progress as planned

The successful applicant;

You will be degree educated in Life Sciences
You will have experience in IVD manufacture/development at a supervisor level
You will have experience working to FDA or ISO13485 standards
You will have an indepth understanding of immunoassays.

The team leader will be required to demonstrate a flexible and organized approach in order for them and their team to achieve the range of project specific and general laboratory tasks within the required and agreed timescales. All work is to be reliably & meticulously completed according to the relevant written procedures and the principles of good laboratory practice, in accordance with current FDA and ISO 13485:2016 requirements. The post holder will be responsible for ensuring all work is precisely recorded at all times using the appropriate paper or electronic systems. They will maintain up to date records of their health & safety and job specific training and be able to demonstrate competence in these.

Supervisory Responsibilities: Minimum of two analytical trials technicians and cover support for the manufacturing team (one team leader and two technicians).

To discuss this role further please call Oliver on 0121 7288454 or email

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.


You must be eligible to work in the UK. Learn more

  • Agency: SRG
  • Reference: J26953
  • Posted: 12th June 2018
  • Expires: 26th June 2018
SRG

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