QC MICROBIOLOGIST (BTSG)

Introduction to role

An exciting opportunity has arisen for a QC Microbiologist (BTSG) to join Porton Biopharma, a leading biopharmaceuticals company located on the historic Porton Down site, in the picturesque countryside of Salisbury, Wiltshire.

Porton Biopharma Limited (PBL) is a limited liability company, established in 2015, to commercialise pharmaceutical development and manufacturing capabilities.  Our mission is to protect patients’ health through the quality-assured development and production of biopharmaceuticals.  We develop new vaccines, therapeutic proteins, and enzyme products, and manufacture our own licensed biopharmaceutical products, Erwinase® and the UK’s Anthrax Vaccine.

We offer specialist expertise in the development of both manufacturing and analytical processes for use with biological pharmaceutical products. Particularly in taking concepts from the research laboratory and progressing them through the various stages of scale-up and process development to manufactured product for licensed supply or clinical trial.

Our employees join us safe in the knowledge that their skills and experience are contributing to a valuable purpose. This is an excellent environment for the right person to build their biopharmaceutical career.

The QC Microbiologist (BTSG) will be in receipt of a competitive benefits package, including:

• 30 days of holiday, plus 8 bank holidays.
• On the job training, and genuine opportunities for growth and advancement.
• Generous pension scheme.
• Access to online discounts.
• A work environment based in the beautiful Salisbury countryside, with free on-site parking, easy access to London and the south coast
• Onsite canteen
• Life Assurance

JOB SUMMARY

To undertake specialist microbiological analyses and perform specialised bioassays to support the manufacture of PBL’s licensed pharmaceutical products as required by EU Directive 91/356/EEC for GMP compliance. To write quality documentation relating to microbiological testing. Support the QC Home Office project license team working at ACDP containment level 2 and 3 where appropriate. To ensure that work performed within the laboratories is carried out in compliance with corporate statutory health and safety requirements

Key Responsibilities

• Operate the QC Microbiology Laboratory in compliance with Porton Biopharma’s safety policy and cGMP
• Ensure analysis, recording of tests and interpretation of data have been performed in compliance with Communicate progress and escalate issues to line manager and / or senior microbiologist.
• Plan and complete assigned tasks within the required timeframe
• Responsible for microbiological testing of samples to ensure that they meet approved specifications.
• Verify analytical raw data and release results from the QC Microbiology department as appropriate
• Hold a Home Office personal license
• Support the QC Home Office project licence team by assisting with bioassay tasks working at ACDP containment level 2 and 3.
• Support Environmental Monitoring as appropriate
• Write SOPs, protocols, reports and risk assessments as appropriate.
• Write quality records such as non-conformances, and devise CAPAs and change controls as appropriate.
• Liaise with external testing laboratories to arrange correct and timely testing.
• Work collaboratively with team to ensure business, regulatory and customer needs are met
• Maintain an up-to-date awareness of regulatory and scientific
• Perform housekeeping of laboratories.
• Receive samples into the lab from internal and external customers
• Ensure all equipment within the QC department is calibrated and serviced
• Identify improvements

The role holder will need to be vaccinated against anthrax to allow them to perform their duties where required within areas where anthrax vaccine is manufactured and tested

The above is only an outline of the tasks, responsibilities and outcomes required of the role.  You will carry out any other duties as may reasonably be required by the manager.

Personal Specification