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Senior Quality Control Analyst

RoslinCT
Job LocationEdinburgh
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

We are looking for a driven individual to join us as Senior QC Analyst in our Analytical/Molecular Biology team.RoslinCT is a world-leading contract manufacturing and development organisation specialising in the field of cell therapies, advanced therapeutic medicinal products and regenerative medicine across a range of therapeutic targets.As part of our continued growth, which includes the opening of our state-of-the-art BioCube facility, we are now recruiting across all of our teams . This role is well suited to an individual with experience in GMP bioassay validation and qualification within a commercial laboratory setting.The Role:You will be a key member of our QC Analytical team and hold responsibility for the QC assay validation and qualification in preparation for our first UK, European and US ATMP product licence registrations. You be responsible for developing, validating and qualifying GMP assays for use within QC and performing laboratory testing and QC on all cell and gene therapy products derived within RoslinCT.Responsibilities:At RoslinCT, we are dedicated to delivering life-changing and cutting-edge therapeutic products to patients. As such, your responsibilities in this position will be varied and will include;

  • Developing, validating and qualifying assays appropriate for characterisation and safety testing of human embryonic stem cell lines and cell and gene therapies.
  • Routine QC testing of cell and gene therapies to GMP standards.
  • Acting as a point of contact for QC oversight of our commercial readiness programme.
  • Reviewing and updating current QC SOPs and establishing new SOPs.
  • Training and certification of all personnel carrying out analytical activities.
  • Ensuring that all processes are subjected to appropriate levels of analytical sampling and review.
  • Leading of investigations into incidents of product contaminations, and compilation and reporting of all analytical data to facilitate product release.
  • Validation of new techniques and processes and training of others in these methods, in addition to validation of equipment.
  • Generation of trend and summary reports for RoslinCT Management and chairing of regular review meetings.
  • Performing and co-ordination of QC batch release testing as required. Completion of GMP documentation incuding Incident Reports, Change Controls and Risk Assessments.
  • Regular communication of results and updates with clients and customers.
    • Qualifications:You will hold a BSc in a Life Science discipline or equivalent relevant laboratory experience.Skills and Experience:You will be able to demonstrate:
  • An excellent understanding and proven track record of working effectively within a GMP analytical/molecular biology laboratory with commercial experience.
  • Experience in assay development, validation and qualification in line with GMP guidelines.
    • Benefits:In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we can offer:
  • Company Pension: RoslinCT will contribute 5% for the first year of joining the scheme with an increase of 1% per year until a maximum of 8% is reached, with a 3% Employee contribution.
  • Life Insurance: Access to RoslinCT’s Group Life Cover at 3x Salary.
  • Wellness Programmes: Access to RoslinCT’s Health4All Cash Plan and Employee Assistance Programme.
  • Competitive Annual Leave Allowance: 31 days, plus 4 Public Holidays across Christmas, with an extra day from 3 years’ service and a further day from 5 years’ service.
  • Company Events: Our Social Committee works hard to bring fun company events to all our staff.
  • Casual Dress: dress down Fridays.
    • Values:A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:
  • Passion for customer satisfaction
  • Ability to support a one team’ approach
  • Great communication
  • Commitment to personal growth and development
  • Accountability for your work
    • Location:We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary. Required skills
  • Assay Development
  • GMP
  • Good Manufacturing Practice
  • Assay Validation

    • Keyskills :
    GMP Assay Validation

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