Director Bioanalysis

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

View more

Discipline
R & D , Bioinformatics
Hours
Full Time
Contract Type
Permanent
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VOLT Life Sciences are seeking a Director of Bio analysis 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.

Responsibilities:

You will execute on the strategy to grow Bio analysis (clinical assays) laboratory function with a remit to develop, validate and operate custom assays for patient screening and/or monitoring.

Co-operate with the Clinical Translation, Medical and Research groups to understand future clinical testing needs and ensure expert input into clinical protocol design, including sampling plans for real time and long term and follow up assessments

Line management, development and appraisal of clinical testing team members

Accountable to ensure secure execution of ongoing patient screening and monitoring assays (in-house and with partners) to support recruitment into clinical studies and timely clinical study data provision

Ensure robust development of assays to meet new clinical requirements in compliance with best practice and relevant regulatory standards

Ensure clinical phase-appropriate validation of assays and data integrity.

Ensure smooth transfer of assays to CROs where needed with continuing technical and business oversight

Ensure appropriate selection and audit/oversight of specialist clinical laboratories and clinical research organizations and develop KPIs to monitor performance on an ongoing basis

Develop and maintain a business plan and operating budget covering staffing, revenue, facility/capital and partnering needs for both near and long-term needs

Transfer in and establish new technologies and assays as required

Requirements

A higher degree in a Life Science or Clinical Science/Biochemistry

A professional qualification in Clinical Science/Laboratory Medicine

Minimum of 10 year's experience in pharmaceutical clinical development, or clinical testing in the healthcare industry

Substantial experience of developing and overseeing clinical testing operations in a regulated environment

Deep understanding of experience of bioanalytical method development, validation and technology transfer, external quality assessment schemes.

Deep understanding of regulatory and quality frameworks for in vitro diagnostic systems and experience of regulatory inspections and laboratory accreditation

Practical experience of analytical techniques such as qPCR, DNA Sequencing, Immunoassays, Electrophoresis, Cell Based Assays

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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