Entrust RS is delighted to be working alongside a publically listed clinical-stage biotechnology company headquartered in the UK with offices in Germany and the USA. The client has an ambitious vision to create better lives for people suffering from chronic systemic diseases using gene therapy as a one-off curative treatment, with a clear focus on gene therapy (AAV) targeting the liver with the aim to provide treatments for diseases with significant unmet patient needs.
Innovation and entrepreneurial spirit is at their core, but their passion is working together as one team and tangibly making life changing impact… So they are looking for talented and passionate professionals who are driven and team orientated. If you share the same vision for excellence and are looking for a high paced work environment, you may be a great fit for our team. The client is looking to appoint a Senior Biotechnologist – USP.
Be part of the Production team responsible 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.
Write and update SOPs and batch records to support GMP manufacture.
Responsible for completing production records to principles of ALCOA prior to quality review.
Ability to identify and escalate issues as they occur, troubleshoot issues through technical expertise, and report accordingly with all relevant information.
To become fully trained in deviations, investigations and change controls and be able to lead investigations, identify root causes and propose SMART CAPAs .
To be a dedicated equipment owner responsible for organizing and leading the use of equipment during batch manufacture, organizing 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.
Educated to degree level or equivalent in a biological science.
At least 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.
Excellent communication, interpersonal and organisational skills.
If this opportunity excites you and you want to work in a fast paced environment then either call on (phone number removed) for further details or alternatively apply
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