upstream process development scientist in offaly

posted
15 April 2019
contact
randstad financial & professional, randstad financial services
job type
contract
salary
£ 31,897.20 - £ 33,576 per year
apply now

posted
location
offaly, international
specialism
pharmaceutical
sub specialism
R&D
job type
contract
working hours
Full-Time
salary
£ 31,897.20 - £ 33,576 per year
reference number
AVKZOET
contact
randstad financial & professional, randstad financial services
apply now

job description

Key Responsibilities:



* To support the development, optimisation, scale-up and validation of all steps in a monoclonal antibody production processes.
* Work with external partners to provide the necessary technical support for successful completion of projects including the transfer of processes into the facility.
* Strict adherence to GMP, working in a cleanroom environment and executing batch records.
* Support the writing and updating of Batch Manufacturing Records, SOPs, and other quality documents required for GMP manufacture.
* Provide hands-on support for all manufacturing activities including buffer / media preparation, integrity testing, cell culture and purification processes.
* Provide technical input and support writing of technical reports required for regulatory purposes
* Participate in Quality and Safety regulatory audits and completion of deviations and investigations into non conformances.
* Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices
* Manufacture products using cell culture techniques and/or chromatography and ultrafiltration diafiltration in downstream steps.

Qualification and Experience:

Basic Qualifications:



* S. or BSC in Chemical/Biochemical Engineering or related Biological Sciences with 1 year of industrial experience.
* Previous hands-on experience running chromatography systems is desired (Unicorn software an advantage).
* Basic cell culture experience, knowledge of bioreactors.
* Working in a controlled regulated environment e.g. GMP/GLP
* Knowledge of analytical methods required for protein characterisation
* Knowledge of key suppliers of process materials and equipment including disposable systems
* Excellent verbal and written communication skills. Ability to maintain very clear records of work completed
* Ability to work effectively as part of a team across all departments

Preferred Qualifications:



* Knowledge and understanding of the workings of protein purification techniques using Unicorn software or cell culture experience and the use of bioreactors at 200L scale.

Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003