Upstream Manufacturing Scientist Essex Competitive Salary + Excellent Benefits
Are you an experienced Upstream Manufacturing Scientist?
Would you like to work for a cutting-edge company working across modern Biological Therapeutics such as Gene Therapy and Cell Therapy?
My client, based in Essex, are specialists in the Research, Development and Commercialisation of Advanced therapy medicinal products, working with Biotechnology and Biopharmaceutical companies to translate early stage research into quality, commercially viable, scalable and investable therapies. They attract leading scientists from around the world, to join their R&D department, which boasts state of the art laboratories and facilities supporting Gene Therapy & Cell Therapy development and industrialisation.
Currently they have a great opportunity for an Upstream Manufacturing Scientist to execute Upstream Manufacturing activities required for Bioreactor derived Bulk Drug substance products to the point of transfer to the Downstream Processing environment.
- Execute direct activities (i.e. seed work / cell culture fermentation, initial purification) in the Upstream GMP operations Manufacturing area in line with department SOP's and Manufacturing batch records.
- Deputise for the Upstream Snr Scientist at relevant Meetings, these may include, Management Review and Planning, Deviation, and Project specific meetings as required.
- Provide data and fact driven responses to questions, co-ordinate responses, Changes and Corrective Actions as appropriate. Assist in the direct delivery of the agreed manufacturing plan to maintain performance as required by schedule and/or project timelines.
- Complete area operations in line with department safety, COSHH, Product and Process Risk Assessments, with all actions and control measures executed as required. Complete Upstream Manufacturing area cleaning / disinfection actions in line with issued schedules and housekeeping standards in order to maintain the Upstream Manufacturing area GMP accreditation.
- Contribute the Upstream Manufacturing Equipment, Processes and the area periodic validation / planned maintenance / calibration activities as required.
- Complete direct Environmental and utilities sampling as scheduled. Escalate Continuous Improvement opportunities within our Operations driving lean, robust and efficient working practices.
- Contribute to root cause investigations, reviews of existing processes and systems and generate Change Actions to drive Improvement and ensure that all appropriate standards are met.
- Science Degree or equivalent in Biology, Chemistry, Microbiology or other Life Science Biotechnology / Pharmaceutical sector related subject
- Manufacturing experience in a Pharmaceutical/ Biotechnology or other highly regulated environment, with extensive knowledge of current GMP rules and applicable regulatory guidelines
- Experience of the manufacture of Biological Products is essential Knowledge of GMP Biologics production, and knowledge of HSE, lean manufacturing and Quality Systems
- Self-motivated, excellent interpersonal, communication and presentation skills and the ability to prioritise effectively and work to tight deadlines
- Ability to problem solve and make informed decisions
- Excellent technical writing skills and a high level of attention to detail
Please apply online or call Umul Ahmed on 0203 0964529.
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