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We are currently looking for a Upstream Processing Expert to join the bioprocess development team at an expanding international biotechnology company based in the Wrexham area. As the Upstream Expert you will be responsible for providing technical leadership for the design, development and validation of fit-for-purpose, robust upstream processes to effectively support biologic product production.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Upstream Processing Expert will be varied however the key duties and responsibilities are as follows:
1. Support effective DOE for process design/optimisation, implementation of appropriate control strategies (QbD) in co-ordination with analytical and process development requirements.
2. Support implementation of appropriate lifecycle strategies, process validation and regulatory documentation to support product development plans, briefing documents and CMC documentation, as required, to ensure successful regulatory approvals.
3. Lead from the bench by implementing new ways of working to increase throughput while maintaining data integrity and traceability.
4. Proactively Support CMC Project Management (Technical Leaders and Project Managers), incorporating upstream expertise and requirements across assigned CMC programs, and more broadly act as a subject matter expect (SME) for all matters concerning upstream processing.
To be successful in your application to this exciting opportunity as the Upstream Processing Expert we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific or Engineering discipline along with significant experience working within Upstream Process Development ideally within a microbial background.
2. Proven industry experience lead Upstream Process Development projects for the production of biopharmaceuticals.
3. A working knowledge and practical experience with DoE (Design of Experiment) and QbD (Quality by Design) will be highly desirable.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.