- Be part of the Production team supporting delivery of GMP manufacturing batches for
- Work with the process development team to transfer processes from pilot laboratory to the fill finish suite.
- Prepare and review documentation for clinical supplies manufacture, including SOPs, batch records, cleaning procedures and environmental monitoring procedures.
- Work with the process development team to transfer manufacturing processes for small batch sterile products for stages one, two and three clinical trial supplies
- Create, prepare and complete the required documentation including SOPs, cleaning procedures and batch records.
- Maintain the facility to GMP standards of cleanliness and environmental standards.
- Manufacture batches for clinical trial supplies including those for phase 1,2 and 3 clinical studies.
- Participate in trouble shooting and investigations.
- Ensure compliance with all regulatory requirements and maintain excellent GMP, quality control and safety.
- Support the sterile Team Leader at weekly meeting, KPI’s, planning and deviation investigations and action CAPA’s.
- Work with single use sterile technologies, and closed systems.
- Undertake warehouse operations including goods receiving, stock management, dispensing and sampling.
- Have the flexibility to operate in all areas of clinical supplies including: sterile operation, equipment validation, product assembly and packaging.
Experience/Skills needed to fulfil the role
- Minimum of 3 years GMP experience in a production environment or clinical trials supplies unit with experience of sterile manufacture and demonstrated aseptic techniques.
- Experienced in Clean Room Grade A environments, Isolators or RABS is desirable.
- Qualified in a safety systems, i.e. COSHH, Risk assessments, Manual handling or IOSH managing safely.
- Experienced working with Excel and Word.
- Evidence of excellent attention to detail and ability to follow Standard Operating Procedures.
- Experience in overseeing validation operation of equipment and participation of SAT’s or FAT’s.
- Knowledge of Six Sigma or Lean manufacturing and implementing continuous improvements is desirable.
- Ideally have a degree in a life science subject.
- Good level of written and spoken English
If you are interested in applying for this position, please apply with a CV and covering letter.