Scientific Development Specialist

3 weeks ago


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

About the Role:

Sterling Pharma Solutions is seeking a highly skilled Analytical Development Scientist to join their team in Deeside, North Wales. As an Analytical Development Scientist, you will play a crucial role in developing and validating 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, and physicochemical analysis at the protein level, including product-related impurities and product developability.
  • 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, as well as ELISA and other relevant techniques.
  • Ensure all testing performed is reported within the most efficient timeframe and maintain accurate laboratory records.
  • Laboratory maintenance, housekeeping, and self-inspections, as well as supporting the re-order system and communicating with key suppliers.
  • Data trending and supporting quality and technical investigations.
  • Preparing and executing laboratory protocols and reports, as assigned.
  • Qualifying reagents, reference materials, analytical techniques, and relevant equipment.

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, solution-focused approach, and experience in troubleshooting and root cause analysis.
  • 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 an advantage.

About Sterling Pharma Solutions:

Sterling Pharma Solutions is a fast-growing global pharmaceutical CDMO (Contract Development and Manufacturing Organisation) with over 50 years' experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). We are a proven and trusted partner to some of the world's most innovative biotechs and leading pharmaceutical companies.

Why Consider Us?

Our collaborative and empowering culture is unique to us and is what really sets us apart as a business, built upon our four core values: Be Transparent, Be Reliable, Be Willing, and Be Caring. We offer a competitive compensation and benefits package, including bonus, pension scheme, private healthcare, and opportunities for training and further career development.



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