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QC Senior Scientist- Flow Cytometry

Hertfordshire, United Kingdom

  • Salary: Dependent on experience
  • Job type: Permanent
  • Posted: 17/07/2019
  • Contact name: Amy Dickinson
  • Contact number:
  • Ref: 4540

Job description

Job Summary
There is an immediate opportunity for bright, enthusiastic scientists to join a manufacturing team committed to delivering high quality products for use in clinical trial programmes. The roles will be based in Stevenage but there will also be opportunities to work within established academic centres in the London area.

Key Responsibilities
Support Clinical Trial manufacturing through performance of QC testing
Support, train and mentor junior members of the team
Lead investigations for OOS / QERs / Change controls relating to QC activities
Qualify and validate test methods and processes to ensure their suitability for use in support of Clinical Trial manufacturing
Select and purchase appropriate QC laboratory equipment. Lead equipment qualification activities
Lead technology transfer of QC test methods into the Product Delivery group
Execute supporting QC stability programmes
Assist in the performance of health and safety risk assessments, COSHH etc
Participate in the development of QC assays suitable for product release or characterisation
Author reports and regulatory documentation as required
Work with external QC service providers
Any other duties as required following consultation with the post holder
The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company
 

Demonstrated skills and competencies
E – Essential

P – Preferred

 

Experience

Directly relevant biotechnology or pharmaceutical industry experience (E)
Experience of working in a busy laboratory environment (P)
Experience of training, mentoring and supervision of junior laboratory staff (P)
Qualifications

Degree or higher degree in Biology/Biomedical Science/Immunology or related discipline (E)
Minimum of 3 years experience in a GMP QC laboratory (E)
 

Skills/Specialist knowledge

Experience with a range of biopharmaceutical and cell-based techniques including some or all of: Aseptic technique, Sterility testing, Cell Counting, Flow cytometry, qPCR, Mammalian cell culture, Potency testing (E)
Good understanding of cell biology and immunology (E)
Strong verbal and written communication skills (E)
Flexible, self-motivated and focused on team outcomes (E)
Understanding of and familiarity with GMP regulations (E)
Excellent organisational skills with the ability to present results clearly and logically, working co-operatively as part of a team as well as independently (E)
Excellent attention to detail and ability to accurately follow SOPs (E)
Ability to identify and implement solutions (E)
Commitment to high quality work (E)