Senior Biotechnologist - USP
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Hobson Prior are looking for a Senior Biotechnologist - USP to join a top clinical-stage biotechnology organisation on a permanent basis in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.
- You will be a part of the Production team accountable for delivering GMP manufacturing batches for clinical studies.
- Become fully trained in all areas of the manufacturing process as required and responsible for practical delivery of key process steps.
- Accountable to write and update SOPs and batch records to support GMP manufacture.
- Responsible for completing production records to principles of ALCOA prior to quality review.
- Become fully trained in deviations, investigations and change controls and be able to lead investigations, identify root causes and propose SMART CAPAs.
- Recognize and escalate issues as they occur, troubleshoot issues through technical expertise, and report accordingly with all relevant information.
- To be a dedicated equipment owner responsible for organising and leading the use of equipment during batch manufacture, organising and delegating tasks in module to junior team members, training team members, trouble-shooting issues, ensuring equipment is serviced as per supplier agreements and remains in a validated state through periodic validation review.
- General duties involved in the maintenance of clean room production facilities to GMP standards and preparation for manufacture.
- To be trained in USP equipment SOPs as required for supporting GMP batch manufacture.
- To be trained in aseptic cell culture processing for seed train expansion prior to USP.
- Excellent communication, interpersonal and organisational skills.
- Educated to degree level or equivalent in a biological science.
- A minimum of 2-3 years of hands-on, practical experience in GMP manufacture of biopharmaceuticals in USP processing.
- A good understanding of the required industry standards for GMP manufacturing of investigational medicinal products.
- Experience of single use manufacturing and pilot scale or large-scale bioprocessing equipment.
- Strong technical understanding and practical experience of USP (seed train, single use bioreactors, depth filtration).
- Previous supervisory experience.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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