In this role you will work as part of a manufacturing operations team. This encompasses the operation of relevant manufacturing equipment following SOP’s and/or PCD’s.
Profile of applicant
The key aspect of this role is to produce GMP compliant biopharmaceuticals to a defined schedule. The ability 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.
Key responsibilities include:
- Operate manufacturing equipment to carry out the cGMP production of Biopharmaceuticals.
- Production processing; incorporating Fermentation, Cell Separation, Chromatography, Final Ultrafiltration and
- In-process Sampling and Analysis.
- Preparation and Operation of all Equipment following SOP’s and PCD’s.
- Calibration of instruments and plant maintenance tasks as required during processing or during maintenance
- shutdown periods.
- Complete all documentation required to GDP.
- Operation of Walsh CIM computer control system.
- Maintain all processing areas in a tidy and compliant manner.
- Disassembly and washing of used equipment.
- Document modifications as and when required according to change control system.
- 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 this.
- 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.
All tasks are to be undertaken in accordance with cGMP.
The candidate will be challenged with the complexity of state of the art automated manufacturing processes that are run on a 12.5hr 24/7 operational basis. This will necessitate the need to work both day and night shifts as part of a small shift team. The candidate will learn to plan resource and multitask effectively whilst having the opportunity to gain a wider knowledge in areas such as in-process analysis, Instrument and Mechanical Engineering, Validation, project management and deviation management in a 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.
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: November 23rd