QC Analyst

Location: Deeside, Wales, UKDepartment: QualityReference: VN221
Summary of QC Analyst role


Sterling Pharma Solutions have exciting opportunities for QC Analysts to join their team in Deeside.

You will have demonstrable experience in the analytical testing of biological pharmaceutical products, such as therapeutic proteins, monoclonal antibodies and Antibody Drug Conjugates (ADC’s), and will have the technical knowledge to support the development and qualification of suitable compliant assays in a regulated environment.

Responsibilities
  • Assisting in the development and qualification of HPLC, UV and capillary electrophoresis-based assays for antibodies and anti-body drug conjugates (ADC’s).
  • Performing and reporting analytical testing on all raw materials, intermediates, finished products and stability samples in HPLC, UC and capillary electrophoretic methods.
  • Performing analytical testing using a variety of techniques, including: pharmacopoeial physicochemical methods; HPLC (SEC, HIC, PLRP, CEX); imaged capillary electrophoresis; iso-electric focusing, SDS CE; spectrophotometry – FTIR and UV – vis.
  • Performing routine tasks and other non-routine tasks required in supporting the analytical development and QC laboratory functions.
  • Ensuring all testing is performed is reported within the most efficient timeframe.
  • Undertaking laboratory maintenance and housekeeping, self-inspections and stock control, supporting the re-order systems and communicating with key suppliers.
  • Data trending and assisting in quality investigations.
  • Documenting laboratory results in accordance with current Good Manufacturing Practice (cGMP) and company procedures.
  • Ensuring training status is compliant with matrix requirements and assisting with training other laboratory staff.
  • Liaising with functional groups both within and outside Analytical Services/Quality Control to ensure projects are progressed.
  • Preparing and executing laboratory protocols and reports.
  • Qualifying reagents, reference material, analytical techniques, and relevant equipment.
  • Embodying our company values, which are: be reliable, be caring, be transparent and be willing.
Requirements for the role
  • Must have a degree in a relevant biological subject area.
  • Previous experience of working in a bio-analytical testing laboratory.
  • Technical experience in the analysis of biomolecules.
  • Experience in techniques such as HPLC, capillary electrophoresis, immunoassays, UV and FTIR would be advantageous.
  • Must have excellent communication and interpersonal skills.
  • Must be organised, flexible and able to work as part of a team.
How you will be rewarded
We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Perkbox, cycle to work scheme, death in service coverage, 24/7 employee assistance programme, employee referral scheme as well as opportunity for training and further career development.

Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 

Sterling is an equal opportunity employer. 


 
Be caring. Be transparent. Be willing. Be reliable.