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    Senior Analytical Development Scientist - Oxfordshire, United Kingdom - Northreach

    Northreach
    Northreach Oxfordshire, United Kingdom

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced therapy, fintech, and digital sectors. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

    Job Summary:

    We are in search of a seasoned Senior Scientist in Analytical Development to join our growing CMC team. The incumbent will spearhead the development and qualification of binding kinetics assays (SPR/BLI) and other physicochemical assays (DSF/DSC, capillary electrophoresis, analytical chromatography) crucial for characterizing and advancing our candidate molecules.

    Key Responsibilities:

    The role entails collaborating closely with Protein Science and Process Development teams to craft and execute analytical strategies, define quality target product profiles (qTPP) and critical quality attributes (CQA), and conduct forced degradation and stability studies to facilitate regulatory approval. Responsibilities include:

    • Developing, qualifying, and executing fit-for-purpose biomolecular interaction and physicochemical assays.
    • Serving as a subject matter expert in various analytical techniques and providing training and support to colleagues.
    • Ensuring timely execution of assays to meet project timelines.
    • Troubleshooting analytical assay issues internally and externally with CDMO partners.
    • Designing and conducting experiments, analyzing data, and presenting findings to cross-functional teams.
    • Leveraging scientific literature and regulatory guidelines to influence CMC strategies.
    • Authoring, reviewing, and approving technical documents such as protocols, SOPs, and reports.

    Minimum Qualifications and Experience:

    • Experience in developing and implementing analytical assays for therapeutic biomolecules, including SPR/BLI, DSF/DSC, capillary electrophoresis, and analytical chromatography.
    • Excellent communication skills and ability to work autonomously and collaboratively.
    • Ph.D. or equivalent scientific experience in molecular biology, biochemistry, protein biochemistry, or biophysics.

    Desired Skills:

    • Knowledge of Good Documentation Practices (cGMP).
    • Qualification of analytical assays.
    • Adaptability to fast-paced biotech environments.
    • Experience with immunoassays (e.g., ELISA, MSD), safety and impurity analytical assays (e.g., endotoxin, HCP, HCDNA), and biologics formulation development.
    • Familiarity with LC-MS based peptide mapping, AUC, FTIR, CD, and oligosaccharide/glycan profiling.
    • Proficiency in mammalian cell culture.
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