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    Senior Analytical Development Scientist - Oxfordshire, United Kingdom - Northreach

    Northreach
    Northreach Oxfordshire, United Kingdom

    1 week ago

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    Description

    Job Description

    Northreach is a dynamic talent solutions specialist that connects businesses with top talent in the cell & gene 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.

    We have partnered with a science led biotech that leverage discovery platforms, that allow them to deliver targeted cancer immunotherapies. They explore the hidden depths of cancer and T-Cell biology to discover, novel immunotherapy targets.

    They are looking for a Analytical Development Senior Scientist to join their CMC function. You will be responsible for developing and qualifying binding kinetics assays (SPR/BLI) and other physiochemical assay such as (DSF/DSC) capillary electrophoresis, analytical chromatography.

    Key Responsibilities

    This role will be responsible for working both independently and in collaboration with the Protein Science and Process Development teams to develop, qualify, and perform fit-for-purpose biomolecular interaction and physicochemical assays to help rapidly advance new candidates from the pipeline into the manufacturing process.

    Participate in defining appropriate analytical strategies, qTPP & CQA assessments, forced degradation and stability studies for product development to obtain regulatory approval.

    This role will be responsible for becoming the subject matter expert in the different analytical assays and you will train and support colleagues in performing and delivering these assays.

    Ensure assays are developed and performed in a timely manner to meet agreed timelines.

    Troubleshoot any analytical assay issues that arise both internally and externally at our CDMO partner.

    Leverage scientific literature, regulatory guidelines (ICH, FDA, EMA), and experience to develop and qualify analytical assays and influence CMC strategies.

    Author, review, and approve technical documents such as protocols, SOPs and reports on assay development, qualification, and tech transfer to and from CDMOs.

    Experience in developing and implementing analytical assays, for example, SPR/BLI,

    Qualifications Desired

    A Ph.D. or equivalent scientific experience in a relevant discipline e.g., molecular biology, biochemistry, protein biochemistry, biophysics.

    Desirable skills

    Knowledge of Good Documentation Practices such as cGMP.

    Qualification of analytical assays

    Ability to adapt to changes and experience in working in a fast-paced biotech company.

    Immunoassays such as ELISA, MSD.

    Safety and impurity analytical assays such as endotoxin, HCP, HCDNA.

    Biologics formulation development.

    LC-MS based peptide mapping, AUC, FTIR, CD, Oligosaccharide/Glycan profiling.

    Mammalian Cell Culture.

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