We are looking for individuals to assist in the transfer and manufacture of sterile small batch
clinical trial supplies from the laboratory to a GMP filling facility. We are currently building a
new purpose-built facility you will have the opportunity to join at the mid stages of the
project and be part of the initial set up involved in the validation and qualification of the
building and equipment. You will have the opportunity to be a member of cross functional
teams, taking part in validation activities and working closely with QA and QC.
We are looking for staff that who have a keen understanding of GMP that can be used to
develop the facility, department and systems.
- 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.
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- 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