Lead Scientist

Title:

Lead Scientist

Company:

Ipsen Biopharm Ltd

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

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 

Join Our Award-Winning Team at Ipsen Wrexham

At Ipsen, we are committed to improving the lives of patients, with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be Great Place to Work certified and a Shingo Bronze Medallion holder, reflecting our commitment to excellence, innovation, and continuous improvement.

With a recent £24 million investment in the site and a further £86.4 million expansion underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive!

IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.