J5630740BerkshireBiotechnology CRO/CMO Science PermanentExperience DependentFull Time12/03/2019Biochemistry Biochemistry – Fermentation / Upstream Processing Biochemistry – Purification Biochemistry – Development / Validation Biochemistry – Production / Manufacturing Cell Culture Technology Transfer
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HRS are currently searching for Multiple Tech Transfer Specialists to join a leading Biopharmaceutical company based in the South East of England. As the Tech Transfer Specialist you will be responsible for leading the technical transfer of multiple concurrent complex manufacturing processes (either Upstream and/or Downstream Processing) using a defined structured approach and expertise between Process Development, through pilot stage accountable for the technical oversight and monitoring ensuring a robust and technically capable GMP manufacturing process.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Tech Transfer Specialist will be varied however the key duties and responsibilities are as follows:
1. You will be a recognised process expert in either USP and/or DSP and you will be responsible for providing detailed technical support, perform complex technical data analysis and deliver the required complex technical process documentation in collaboration, negotiation and discussion with external customers, team SME's and internal stakeholders as required.
2. Hold accountability for the introduction and support of qualification of new process technologies into cGMP manufacturing, whilst managing technical risks associated with process transfer, leading cross functional teams to ensure relevant transfer and communication of critical process and technical information such that successful outcomes are achieved as agreed with customer.
3. Keep abreast of external biopharmaceutical manufacturing technology advancements, understand and introduce new technologies and how they may be applicable to process innovation, cost or yield improvement.
4. Represent Tech Transfer within multiple complex customer facing product project teams using a standard methodology/procedure to successfully transfer both existing as well as evaluate new technologies either into USP and/or DSP cGMP biologics manufacturing from development through scale-up and pilot scale facilities.
To be successful in your application to this exciting opportunity as the Tech Transfer Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree and/or PhD in Biochemical Engineering or similar along with significant biopharmaceutical industry experience.
2. Proven industry experience in either process development or manufacturing of biopharmaceutical drug substance is essential.
3. A working knowledge and practical experience with scale-up and tech transfer of processes into a cGMP facility.
Key Words: Upstream, Downstream, Process Development, Manufacturing, Biopharmaceuticals, ATMP, Tech Transfer, MS&T, MSAT, MAbs, Monoclonal, Bioreactor, Purification, AMBR, AKTA, Design of Experiment, Quality by Design.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.