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Upstream Process Development Lead- Antibodies- Reading

Upstream Processing Lead – Antibodies- Reading

A unique and exciting opportunity has arisen for an Upstream Processing Lead 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 lead the internal technology transfer of processes
and implement scale-down models to GLP standards, undertake risk-based and experimental studies to optimise and characterise the processes and subsequently contribute to/lead external technology transfer of the processes to a 3rd party for GMP contract manufacture. The role is predominantly lab based and will also involve directing the work of 1-2 upstream scientists in the early years. As the laboratory is newly established, there will be some involvement in setting up lab system and procedures, equipment commissioning, preparing documentation, training others and cross training in downstream and analytical procedures to support the broader team.

Key Duties:

*Lead internal and external technology transfer of cell culture, bioreactor and harvest
processes for bio-therapeutic products to the UK site and later externally to 3rd party contract manufacturer(s).
* Design (using OFAT, DoE techniques) and perform process development studies to
increase process understanding, establish proven acceptable ranges, optimise
performance and characterise/validate upstream unit operations.
*Oversee the cell culture and upstream activities related to the running of a small antibody
process development unit
* Execute seed train and shaker incubator runs along with routine 2-10L single use
bioreactor runs with associated growth, metabolite and dissolved gas monitoring assays
*Identify and implement process improvement and optimisation studies in media, feeds
and bioreactor operation and control strategies.
*Train and direct others in executing routine upstream activities, acting as subject matter
expert
*Perform in-process analytical tests as part of a larger team.
*Author and review Study Protocols and Reports prepared to GLP standards
*Prepare 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.

Requirements:

*PhD/MSc in Biological or Bio-Engineering discipline with >5 years of industry related
experience.
*Experience designing upstream cell culture and bioreactor processes suitable for GMP
*Experience planning and executing upstream characterisation studies within BLA
programs, indentifying Critical Process Parameters, Quality Attributes and familiarity with
ICH guidelines
*Knowledge and practical experience of clone selection, cell line development, selection of media and feeds, shake flask experimentation, cell banking, bioreactor process
development, titre improvement and overall optimisation
* Understanding of protein characteristics and critical attributes so as to direct bioreactor development and product/process control strategies.
* Knowledge and experience with metabolite analysis, cell counting and viability assays,
spent media analysis,
* Practical experience selecting, optimising, and sizing harvest filter trains
* Knowledge of the broader Industry, antibodies, companies, regulations (ie GMP, GLP, ICH) and regulatory pathways (ie QbD)
* Experience undertaking technology transfer into/out of companies.
* Experience working with CMOs
* Experience supporting CMC documentation
* Proven ability to methodically plan own and direct others’ work

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, lgripton@pararecruit.com

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: Lg647897_1540893027

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Salary Currency: GBP

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Recruitment Consultant: Lauren Gripton

Recruitment Consultant

Lauren Gripton

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