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I am currently working with one of the top ten global biotechnology companies to watch in 2020, who have real focus on the development and commercialization of unique gene therapies to change lives. They have a strong pipeline with two clinical trials ongoing, where one trial has just moved into phase 3. This allows my client to have a real chance to change the lives of patients by providing directed gene therapy as a lifelong and potentially curative treatment.
Within this opportunity you will have full control over my client's QC strategies across manufacturing/tech transfer, QC GMP labs, QC analytical development, process development and clinical programmes. Here is a chance for you to build and develop your own team to instruct delegation of duties to team members, training programs and business plan for your team.
Provision of training, coaching and mentoring of junior scientists and contribution to an ethos of excellence and high achievement.
Working with Analytical development, ensure creation and delivery of optimal QC strategies for clinical Programmes, covering product/process development, batch release, stability and provision of data for regulatory submissions.
Accountable to support and manage outsourced programmes of work, providing scientific scrutiny and interpretation, ensuring commercially viable outcomes.
Development of laboratory capacity/facilities and expertise in GMP QC labs ensuring best practice and technical excellence.
Oversee QC laboratory operations compliance with GMP standards.
Develop specifications and testing protocols commensurate with stage of product development.
Oversee technology transfer of GMP QC tests between labs.
Set implement of strategies for the continued development of QC testing capability including building and gaining approval for the GMP QC function business plan.
Manage analytical methods transfer, development and validation at partner contract research organisations, ensuring compliance with relevant specifications, standards and processes, ensuring data integrity.
Support Quality Assurance auditing of service providers from a Technical perspective.
BSc in Analytical sciences, Biological science or related discipline.
You will have a minimum of 10 year's experience of Quality Control in the pharmaceutical industry with experience of biopharm/vaccines. Prefered experience in cell/gene therapy products.
Practical experience of analytical validation and technology transfer.
Practical experience of analytical techniques such as qPCR, DNA Sequencing, Immunoassays, Electrophoresis, Cell Based Assays.
Extensive knowledge of GMP and Regulatory requirements.
Prior experience in Quality Management Systems.