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Bioburden Validation Project Manager

An individual with extensive microbiological expertise is required to manage and carry out a bioburden evaluation and control project in a biopharmaceutical manufacturing facility.

The right person needs to have some years track history in GMP and in pharmaceutical aseptic processes, ideally using a risk-based approach and with experience of the requirements of the FDA. Experience in setting up and managing a bioburden control programme in the pharmaceutical industry is essential.

The person appointed will be required to undertake a holistic review of the impact of bioburden on the process as a whole and to devise and execute validation plans, methodologies and protocols for demonstrating control at various stages of the process from raw materials through increasing levels of stringency to the final sterile product. These steps will include fermentation and downstream processing, extraction and purification, formulation, sterilisation by filtration and aseptic filling into final containers. Experience in all these areas of bioprocessing would be an advantage, especially in the more critical stages.

The project is part of a wider project to validate a therapeutic enzyme manufacturing process prior to licensure in the US and is linked tightly to the current manufacturing schedule, which also includes programmes of process and cleaning validation.

An early start date as soon as can be arranged is required.

This is a 6 month contract position. Candidates MUST have hands on experience of biopharmaceutical process.