Purpose of Role:
This is a fixed term contractual position to support with the implementation of some internal projects on site.
The Upstream Manufacturing Scientist roles at the Centre in Braintree are required to directly execute Upstream Manufacturing activities required for Bioreactor derived Bulk Drug substance products to the point of transfer to the Downstream Processing environment.
The Upstream Manufacturing Scientists will complete all department documentation in a manner compliant with the principle of ALCOA. i.e. Attributable, Legible, Contemporaneous, Original, and Accurate.
The Upstream Manufacturing Scientists will also be responsible for data entry and signing for in process actions. These records may include but are not limited to; cell / viral banking, fermentation, and upstream product recovery steps.
Additional activities include supporting downstream activities under the direction of Senior Downstream Scientists.
Key Accountabilities:
- 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.
- Direct ALCOA compliant completion of Upstream Manufacturing related documentation, including the Process Batch Records and Upstream area logbooks and records.
- 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.
Experience
- 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 / Skills / Competencies
- 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
- Excellent technical writing skills and a high level of attention to detail
Education / Qualifications
- Educated to a degree level within a Life Science subject.
- ALL CANDIDATES MUST HAVE THE RIGHT TO WORK IN THE UK