Analytical Development Scientist

Performs analytical testing of biological pharmaceutical products, such as therapeutic proteins, monoclonal antibodies, bioconjugates or Antibody Drug Conjugates (ADC's), and possesses the technical knowledge to support the development and qualification of suitable scientifically robust assays in a regulated environment.

The Development Scientist is 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. Supports troubleshooting as required to the wider operations teams. 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.

Working collaboratively with other scientists and project managers to achieve the project objectives and deliver high-quality solutions to our clients.

• The development and qualification of analytical methods for Biomolecule characterisation, Bioconjugate/ADC testing, Physicochemical analysis at the protein level including product related impurities, Product Develop ability, Clinical in use studies, Formulation Development.
• Performing analytical testing, using a variety of techniques including:
• Pharmacopeial physicochemical methods
• HPLC (SEC, HIC, PLRP, CEX)
• icIEF
• CE-SDS
• Spectrophotometry; FTIR and UV-VIS
• ELISA
• 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.

• BSc or equivalent qualification in a relevant biological subject area.
• Experience in a bio-analytical testing laboratory (academic or industry)
• Possess the technical and scientific knowledge to lead the development and qualification of non-regulated and suitable compliant assays within a regulated environment including validation of methods to ICH.
• Demonstrable experience in the bioanalytical testing of biological pharmaceutical products such as ADCs, Therapeutic Proteins or Monoclonal antibodies using techniques such as HPLC, UPLC, Capillary electrophoresis (IEF, SDS).
• 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.
• Awareness of cGMP and regulatory requirements including the United States (USP) and European (Ph. Eur.)…