Reporting to:   Head of Quality Control

Summary of job description:

The post holder will:

  • Be part of a dedicated team that is setting up a Quality Control lab to test Oncolytic viruses for the treatment of cancer
  • Establish QC test methods using techniques such as bioassays, ELISA's, qPCR, chromatography & electrophoresis
  • Perform QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP)
  • Assist with setting up, qualifying & maintaining QC systems and equipment
  • Assist with scheduling, performing & review of test results to support product release and stability
  • Maintain GMP compliance in the QC laboratory.

Key responsibilities:

  • Establish, revise and maintain procedures for QC testing
  • Set-up & maintain QC systems required for cGMP compliance 
  • Review testing data of other analysts
  • Assist with the maintenance of QC laboratory and equipment
  • Be responsible for protocol and report generation of assay transfers
  • Perform QC testing of final drug product, raw materials, in-process, water and product samples following Standard Operating Procedures (SOPs)
  • Review and complete documentation in accordance with cGMP
  • Be responsible for change control and deviations related to QC operations including OOS, OOT, and lab investigations
  • Assist with audits and regulatory inspections
  • Assist with QC laboratory equipment validation
  • Interact internally and with cross functional groups to communicate QC requirements & progress updates 
  • Oversee sampling and storage of QC samples and maintain retain inventory
  • Coordinate shipping of samples to Milton Park and contract testing laboratories
  • Assist with training of others within department within the scope of knowledge and responsibilities.

Educational Requirements:

  • Degree holder or several years’ relevant experience.

Hours of work:

  • 37.5 hours per week Monday to Friday inclusive.  The company operates a flexible working arrangement between the hours of 8 am and 6 pm.  It is expected that full-time staff work 7.5 hours each day, with an unpaid lunch break of 1 hour each day.

Salary:

  • £24K - £32K plus pension scheme, optional BUPA membership, 25 days holiday and other staff benefits.

Please apply with covering letter and CV to Avani.Thakar@replimune.com