Lead Scientist

Lead Scientist

Ipsen Pharma

Wrexham, United Kingdom

The Lead Scientist role within Product Characterisation is an exciting new position that promises a dynamic and varied work environment where no two days are the same. As the successful candidate, you’ll be a leader in the laboratory, providing technical and strategic leadership for internal and external characterisation activities that support the CMC development of toxins and other biological entities.

The role involves the design and development of state-of-the-art biologics characterisation tools and approaches that are delivered internally and through external Contract Development and Manufacturing Organizations (CDMOs). This position is ideal for a proactive and experienced scientist who thrives in a fast-paced setting and is passionate about driving innovation and excellence in biologics research and development

Role responsibilities:

• Design and implement internal product characterisation capabilities aligned with the development of Ipsen’s biologics pipeline:
  • Lead the design and implementation of in-house, state-of-the-art characterization methods incorporating mass spectrometry;
  • Develop and deliver product characterization workflows that enable product and process understanding through the elucidation of biologics structure, the assessment and definition of Critical Quality Attributes (CQAs), and the characterisation of impurities and degradation pathways;
  • Support product quality testing to meet regulatory expectations and ensure patient safety.
• Define the characterization strategy for Ipsen’s biologics pipeline:
  • Define the product characterisation strategy across the product development lifecycle for a range of molecular entities including ADCs, fusion proteins and bispecifics;
  • Provide technical oversight of external CDMOs to ensure delivery of work packages aligned with the product characterisation strategy;
  • Effectively communicate strategy, data, and recommendations to functional teams, CMC teams, and external partners.
• Maintain fit-for-purpose facilities, procedures and documentation aligned with Ipsen’s needs:
  • Lead the implementation of improvement programs, new procedures and processes within the Product Characterisation function;
  • Suggest improvements based on deep knowledge of technical aspects and experimental data;
  • Contribute to the preparation, review and approval of Plans, Protocols, Records, Reports, SOPs, Training Packages and other associated documentation as required.
• Key Technical Competencies:
• Demonstrate expert knowledge of mass spectrometry including the latest advancements in the field;
• Apply acquired expertise in mass spectrometry to develop industry-leading approaches to the characterisation of biological molecules;
• Apply broad understanding of protein structure, function and post-translational modifications to a diverse range of biological entities.

Knowledge & Experience (essential):

• Bachelor of Science degree and relevant experience in biopharmaceutical development;
• Broad experience with various mass spectrometry instrumentation and software packages;
• Expert knowledge of mass-spec based biological characterisation techniques including peptide mapping, intact and reduced mass, disulphide linkages;
• Experience with advanced mass spectrometry workflows e.g. Host Cell Protein characterisation;
• Knowledge of protein modifications, degradation pathways and impurities, and application of that knowledge to CQA assessments;
• Proven experience in method development and optimization.

Knowledge & Experience (preferred):

• Master’s degree in Biochemistry, Biotechnology, or related discipline;
• Experience of regulatory-supporting characterisation packages including method qualification, reference standard qualification, and comparability studies;
• Experience with other physico-chemical techniques e.g. ion-exchange, cIEF, HILIC, Capillary Electrophoresis, HIC;
• Knowledge of CMC Development;
• Experience of working with CDMOs and external partners;
• Bioinformatics experience.

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