Quality Control Associate- Stem Cell - GMP - £28K - South Wales - Cell Culture-Potency Assay

A well-known SME, life sciences company have an exciting opportunity for a Quality Control Associate to join the team. Joining at an exciting stage of growth, you will be required to take over the running of the potency assay testing for Drug Product release. You will be based in Surrey for the first 6 months until moving back to the HQ in S.Wales in March 2015.

Company Background

A well-known SME, life sciences company, with unique and pioneering technologies already delivering therapeutic product candidates that are in the clinic. Its primary objective is the development of novel stem cell therapies targeting areas of significant unmet or poorly met medical need.

All of the company's current operations - R & D, Manufacturing Development, Clinical, Regulatory, Admin etc. are based in Surrey. Manufacturing of clinical material is currently outsourced to CMOs.
It is the intention of the company to move its base to South Wales within the next 12 months to a brand new, custom-built facility that will house both the R & D Group and a new state of the art manufacturing facility. This facility will then produce material for the planned Phase III trial through to market authorisation and commercial supply.
The current headcount is c. 30, but this is anticipated to rise to c. 50 during 2015 as the new manufacturing facility comes on line.

The Need

In line with establishing its own manufacturing facility, they will also need to develop an in-house QC function. Currently clinical product is manufactured by CMOs who also carry out all QC testing with the exception of specialised, biological potency assays for final Drug Product release which have been developed and are run by staff from within the Research and Process Development teams.
The company now wishes to create an in-house QC function initially to take on responsibility for running the potency assay tests. This role is the first recruitment into this new team and will report to the new QC Manager who is being recruited simultaneously. It is hands- on lab based role initially based in Surrey but will transfer to the new facility in Wales early in 2015.

The Role

The key responsibility is to take over the running of the potency assay testing for Drug Product release. When the manufacturing facility goes into production in 2015 the testing regime will be expanded to the full spectrum of QC testing covering raw material release, in-process control, final product release and environmental monitoring.

Responsibilities

*Perform QC potency assays against a defined product release timetable. The assays are complex biological tests and require skills in cell culture techniques as well as chemical analytical techniques.
*Complete paperwork for each test in compliance with GMP
*Maintain laboratory and equipment maintenance for the QC function to ensure results are not delayed by equipment malfunction or lack of materials etc
*Train new team members in assay techniques as they are recruited
*Take on new testing work across the spectrum of QC functions for release specification testing, raw material testing, in-process control testing and environmental monitoring testing as required.
*Contribute to the writing of SOPs for the new QC function



Qualification

*Degree
*At least 2 years experience in performing assays preferably involving cell cultures techniques or in lab work activities involving cell culture such as cell banking.
*A knowledge and understanding of working to GMP
*Cell culture experience


Please note: This role will require to be based in Surrey for the first 6 months until they move to their new South Wales HQ in March 2015.

Quality Control Associate - £28k - PermanentApply now