Director GMP Quality Control

Employer
Volt
Location
Stevenage, England, GB
Salary
Competitive
Closing date
24 Sep 2020

View more

Discipline
Quality, GMP
Hours
Full Time
Contract Type
Permanent
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VOLT Life Sciences are seeking a Director of Quality Control (GMP) in Stevenage. Please see below.

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.

Responsibilities:

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.

Requirements

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.

Apply now

Volt’s European business is wholly owned by Volt Information Sciences, Inc. a global company with operations in over 110 offices covering Europe, the Americas and Asia. Generating annual revenues in excess of $1.5 billion, the company delivers best in class Talent, Technology and Consulting services to its customers.

Volt first traded in Europe in 1978, initially delivering temporary and permanent IT recruitment solutions to clients in the UK. The company has since enjoyed significant growth in both the range and geographical scope of its services, and now has European bases in Belgium, France and the UK, delivering: 

Life Sciences

Engineering

Professional Services

IT

Contact Us
  • Volt House
  • 3 Chapel Road
  • Redhill
  • RH1 1QD
  • GB
  • +44 1737 774100
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