Process Biotechnologist, Clean Suite and Dispensary
Profile of applicant:
The key aspect of this role is to produce GMP compliant Biopharmaceuticals to a defined schedule. The candidate has to be a team player working closely as part of a small shift team is essential. Working to cGMP requires attention to detail and the discipline to follow written instructions and to record data correctly and accurately. Good communication skills are also essential as a key aspect of the role is the liaising with other process staff and prioritisation of the work load.
- Operate manufacturing equipment to carry out the cGMP production of Biopharmaceuticals.
- Complete all documentation required to cGMP.
- Operation of Walsh CIM computer control system.
- Maintain sufficient levels of raw material stocks for ongoing production requirements.
- Maintain sufficient levels of dispensed recipes for ongoing production requirements.
- Ensure cleanliness of dispensary and clean suite according to current procedures.
- Preparation of solutions, bottles and equipment as required by production.
- Formulation of bulk product, final product filling, handling, inspection, incubation, labelling.
- Disassembly and washing of used equipment.
- Document modifications as and when required according to change control system.
- Complete documentation to current GDP.
- Assist in closure of operations related IOD’s, CR’s and CAPA.
- Assist staff in other departments, as required, to perform their tasks in the Production environment.
- Filter control and integrity testing.
- Use of the production autoclave.
- Contribute toward project/validation work as required.
- Maintain own training status to be competent to perform the above and keep records to demonstrate
- Contribute to a safe working environment at all times by adhering to company Environmental and
- Health and Safety procedures and guidelines
- Actively contribute toward the company OP-EX programs.
- Manage minor problems promptly and report others to Supervisory staff
The candidate will be challenged with the complexity of state of the art automated manufacturing processes that are run on a 24/7 operational basis. The candidate will learn to plan resource and multitask effectively whilst having the opportunity to gain knowledge of the production process, and project and deviation management in highly regulated production environment.
The candidate will enjoy the challenge of working to a schedule and problem solving in real time is part of the job requirements.
There are no formal minimum requirements for this position although typically candidates will have an A level science background. Knowledge or previous experience of working to cGMP and in a pharmaceutical environment is preferred. The candidate must show the aptitude and ability to perform the process tasks involved without supervision.
Albumedix is a science-driven, biotechnology company focused on developing superior biopharmaceuticals utilizing our albumin-based drug enhancing technologies. Dedicated to Better Health, we partner with excellence to improve therapies for people with serious diseases. We are proud to be recognized as the world leader in recombinant human albumin with products and technologies used in clinical and marketed drugs by pharmaceutical companies worldwide. Headquartered in Nottingham, England with more than 100 people all committed to improving patient quality of life. We are just as passionate about albumin and albumin-enabled therapies today as we were when we started 30 years ago.
Send your application to: firstname.lastname@example.org
Deadline: December 7th