Upstream Process Development Scientist- Antibodies – Reading
A unique and exciting opportunity has arisen for an Upstream Process Development Scientist to join an international biopharmaceutical company who are opening a brand new state-of-the-art manufacturing process development facility in Reading. As an organisation they are entering into a significant period of growth and investment to support the next phase of development for their innovative R&D pipeline.
The main responsibility of the role is to perform cell culture and bioreactor process development, optimisation and characterisation studies for antibody/CHO based production processes. The role is predominantly lab based and as the laboratory is newly established, there will be some involvement in supporting the setup of lab systems and procedures, equipment commissioning, preparing documentation and cross training in downstream and analytical procedures to support the broader team.
*Support the technology transfer of cell culture, bioreactor and harvest processes for biotherapeutics and later externally to 3rd party contract manufacturer(s).
*Perform process development studies to increase process understanding, establish proven acceptable ranges, optimise performance and characterise/validate upstream unit
*Upstream techniques include;
-Development and optimisation of media and feed strategies and operational
parameters using shake flasks and multiple 2-10L bioreactors.
-Cell counts, viability, metabolite, dissolved gas analysis for monitoring bioreactors
and cell cultures
-Research cell banking, small scale cell culture work and aseptic manipulations
*Perform in-process analytical tests as part of a larger team.
*Perform data analysis and interpretation, delivering internal, external presentations and
preparing reports suitable for GLP/GMP use and CMC submissions.
*Prepare other GLP/GMP documentation to support above activities, including SOPs, URSs,raw material/in-process specifications.
* General housekeeping, stock taking, ordering, laboratory cleaning, reagent/buffer prep.
*BSc/MSc in Biological or Bio-Engineering discipline with >2 years of industry related
experience in therapeutic antibody process development.
*Experience developing upstream processes suitable for GMP.
*Experience executing cell culture and bioreactor characterisation studies within BLA
programs strongly preferred.
*Knowledge and experience with bioreactor control systems (and single use vessels) suchas Bioflo, Biostat or equivalent is essential
*Experience working under Quality Management Systems (ie GMP, GLP)
*Experience undertaking technology transfer into/out of companies preferred.
This is a fantastic opportunity to be involved in the set-up of a brand new facility and to really have an impact on the science, technical capabilities and laboratory output from the beginning. In return the company are offering a very competitive salary and benefits package. For further information on this superb opportunity please feel free to contact myself, Lauren Gripton of Paramount Recruitment, email@example.com
Keywords- USP, upstream, up-stream, process development, bioprocessing, bioprocess.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
Job Reference: Lg635345_1535559058
Broadcast As: 196
Salary Currency: GBP
Salary per: Annum
Job Type: Full Time
Job Term: Permanent
Job Industry: Biotech
Job Specialism: Science R and D
Recruitment Consultant: Lauren Gripton