Principal Consultant: Helen M Brannan BSc CBiol MSB MRQA

An enthusiastic Quality Assurance professional with over ten years experience in the biotech/ pharmaceutical industry, in both GMP and GCP regulated environments; with a strong background in R&D, Drug Development and QC.

A Qualified Person (QP) under the (permanent) provisions of EU Directive 2001/83/EC, specialising in the manufacture, testing and release of biological Investigational Medicinal Products (IMPs) for use in clinical trials in the EU, US and Canada; with experience of aseptically prepared small volume parenterals (autologous cell-based products and oncolytic viruses), novel cellular gene therapy vaccines, sterile lyophilized solids for reconstitution for infusion (synthetic small molecule cell cycle inhibitors) and tissue engineering.

Nine years experience working in the fields of oncology (haematological tumours, solid tumours, malignant melanoma, head and neck cancer, pancreatic cancer & breast cancer), infectious and terminal diseases (including cystic fibrosis & chronic obstructive pulmonary disease (COPD)) and regenerative medicine.

Helen Brannan is a Chartered Biologist and Member of the following professional bodies:

• Society of Biology (formerly the Institute of Biology (IOB))
• British Association of Research Quality Assurance (BARQA)
• Pharmaceutical Quality Group (PQG)
• Professional Contractor's Group (PCG)
• EU QP Association

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