Analytical Development Scientist

Summary of the Analytical Development Scientist role
Sterling Pharma Solutions currently have exciting opportunities for Analytical Development Scientists to join their Analytical Services team in Deeside, North Wales.
As the Analytical Development Scientist, you will report directly to the Senior Analytical Development Scientist and be responsible for the development and validation of new analytical methods as required by clients or regulations for process development, product release, stability testing and characterisation of bioconjugates/ADCs.
You will offer troubleshooting support to the wider operations teams and provide technical expertise. You will also ensure that all laboratory work is performed in accordance with the relevant standards and protocols, and that the results are accurate, reliable, and delivered on time. You will also work collaboratively with other scientists and project managers to achieve the project objectives and deliver high-quality solutions to our clients.
Sterling's facility in Deeside site can be found lying alongside the waterways of the River Dee, presenting a quintessential glimpse of life in North Wales, with numerous nature parks, shopping centres and rural villages, providing plenty of opportunities to get out and explore. It's just a short journey from the cities of Chester, Liverpool and Manchester or you can choose to go a little further afield and from the mountains of Snowdonia to the all Wales coastal path, walking is a dream in North Wales.
Who Are We?
We are a fast-growing global pharmaceutical CDMO (Contract Development and Manufacturing Organisation), with more than 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 and are widely recognised for our expertise in complex and hazardous chemistry.
We are a dynamic business, employing more than 1300 talented and passionate people in the UK, US and Europe who together support our customers in bringing new medicines to market, improving and saving the lives of patients. We support our customers through the full product lifecycle from pre-clinical development right up to full scale commercial manufacturing and today we are proud to have built a culture of excellence in science and unrivalled service.
Your responsibilities

• Developing and qualifying analytical methods for Biomolecule characterisation, Bioconjugate/ADC testing, Physicochemical analysis at the protein level including product related impurities, Product Developability, Clinical in use studies, Formulation Development.
• 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;
  • ELISA
  • Other relevant techniques
• Performing routine tasks and other non-routine activities required in support of analytical development.
• Ensuring 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 and 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.
• Work with due regard to health and safety of self and others.
• Work flexibly across the site to meet business needs.
• Embodying our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.

Requirements for the role

• 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 have a Solution-focused approach with experience in trouble shooting 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.
• 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.
• Must align to our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.