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Downstream Process Development Lead- Reading

Downstream Process Development Lead- Reading

A unique and exciting opportunity has arisen for a Downstream Process Development 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 responsibilities of the role are to lead the internal technology transfer of processes,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 involve directing the work of 1-2 downstream scientists in the early years. As the laboratory is newly established, there will be some involvement in setting up lab systems and procedures, equipment commissioning, preparing documentation, training others and cross training in upstream and analytical procedures to support the broader team.

Key Duties:
*Lead technology transfer of downstream processes for bio-therapeutic products 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 downstream unit operations.
*Oversee the downstream activities related to the running of a small antibody process development unit;
-Purification activities with Protein A affinity, ion exchange, hydrophobic interaction,
mixed mode, hydroxyapatite chromatography, in column (and membrane) format.
-Perform bench scale tangential, depth, sterile and virus (sizing) filtration studies.
*Develop novel downstream processes for new antibodies that may enter the facility
directly from other collaborators.
*Train and direct others in executing routine purification activities, acting as the
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
*Perform data analysis, interpretation, delivering internal, external presentations and reports.
*Prepare GLP/GMP documentation to support above activities, including SOPs, URSs, raw material/in-process specifications.

Requirements:

*PhD/MSc in Biological or Bio-Engineering discipline with >5 years of industry related
experience.
*Experience designing downstream processes suitable for GMP
*Experience planning and executing downstream characterisation studies within BLA
programs, indentifying Critical Process Parameters, Quality Attributes and familiarity with
ICH guidelines
*Knowledge and extensive experience of chromatography using AKTA systems and
UNICORN software.
* Practical experience selecting, optimising, and sizing sterile, depth, tangential and virus filters and unit operations
*Understanding of protein characteristics and critical attributes so as to direct purification
development and product/process control strategies.
*Experience undertaking technology transfer into/out of companies and experience working with CMOs
*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: Lg4535_1533226804

Broadcast As: 196

Salary Currency: GBP

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Recruitment Consultant: Lauren Gripton

Recruitment Consultant

Lauren Gripton

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