Qualified Person Service for Investigational Medicinal Product (IMP)

Tender description

NHSBT are looking to appoint a suitable Qualified Person (QP) on a contract basis to work alongside its existing in-house QPs to support a very active and rapidly growing portfolio of Investigational Medicinal Product (IMP) manufacturing projects. Lot 1: NHSBT are looking to appoint a suitable Qualified Person (QP) on a contract basis to work alongside its existing in-house QPs to support a very active and rapidly growing portfolio of Investigational Medicinal Product (IMP) manufacturing projects.<br/>NHSBT has developed the capability over at least 20 years to manufacture a range of Biotechnology, Gene Therapy, Cell Therapy and Tissue Engineered Medicinal Products for Phase I/II clinical Trials. Many of these are categorised as Advanced Therapy Medicinal Products (ATMP) in accordance with EU Regulations. IMP manufacture is focused at NHSBT facilities in Barnsley, Bristol, Birmingham, and Liverpool holding appropriate MIA(IMP). NHSBT manufacture IMP for both internally sponsored Clinical Trials and under contract for academic and commercial clients. <br/><br/>The services we require the Qualified Person (QP) to support are as follows:<br/><br/>· Advice on regulatory and quality compliance requirements for specific Biological and ATMP manufacturing projects.<br/><br/>· Input to selected regulatory submissions<br/><br/>· Input to design of selected processes and facilities<br/><br/>· QP Certification of batches of biological & ATMP for use in approved clinical trials<br/><br/>· Mentoring of selected NHSBT staff through the process of obtaining QP registration