Analytical Development Scientist

1 week ago


Ellesmere Port, Cheshire, United Kingdom Sterling Pharma Solutions Full time
Job Description

Role Summary

Sterling Pharma Solutions is seeking an experienced Analytical Development Scientist to join their Analytical Services team in Deeside, North Wales. As an Analytical Development Scientist, you will be responsible for the development and validation of new analytical methods for process development, product release, stability testing, and characterisation of bioconjugates/ADCs.

Key Responsibilities

  • Develop and qualify analytical methods for biomolecule characterisation, bioconjugate/ADC testing, physicochemical analysis at the protein level, including product-related impurities, product developability, clinical in-use studies, and formulation development.
  • Perform analytical testing using various techniques, including pharmacopoeial physicochemical methods, HPLC (SEC, HIC, PLRP, CEX), imaged capillary electrophoresis, iso-electric focusing, SDS CE, spectrophotometry, FTIR, and UV-vis, ELISA, and other relevant techniques.
  • Perform routine tasks and other non-routine activities required in support of analytical development.
  • Ensure all testing performed is reported within the most efficient timeframe.
  • 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 and technical investigations.
  • Accurately documenting laboratory results in accordance with company procedures.
  • Ensuring training status is compliant with matrix requirements and assisting in training other laboratory staff.
  • Maintaining and improving knowledge of bio-analytical techniques and procedures.
  • Liaising with functional groups both within and outside Analytical Services as appropriate to ensure projects are progressed.
  • Preparing and executing laboratory protocols and reports, as assigned.
  • Qualifying reagents, reference material, analytical techniques, and relevant equipment.
  • Working with due regard to health and safety of self and others.
  • Working flexibly across the site to meet business needs.

Requirements

  • BSc or equivalent qualification in a relevant biological subject area.
  • Previous experience in a bio-analytical testing laboratory.
  • Demonstrable technical experience in the analysis of biomolecules is essential, and a solution-focused approach with experience in troubleshooting and root cause analysis is required.
  • Technical experience in some of the following techniques - HPLC (SEC, HIC, PLRP, IEX, HILIC), CE-SDS, CIEF, UV, and FTIR spectrophotometry.
  • Experience of Quality by Design (QbD) and Design of Experiments (DoE)/Statistical modelling methods & software packages is an advantage.
  • Excellent communication skills and the ability to deliver an effective presentation on technical content to a wide audience.
  • Good interpersonal and organisational skills; demonstrating attention to detail and able to work in a team and individually.
  • The ability to critically assess data and have a flexible approach to new work challenges.
  • Good awareness of cGMP and regulatory requirements, including the United States (USP) and European (Ph. Eur.) Pharmacopoeias, and current International Council for Harmonisation (ICH) guidelines applicable to the role.


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