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Amgen Principal Scientist - Process Development - Rare Disease Business in Dún Laoghaire, Ireland

Title: Principal Scientist

Process Development - Rare Disease

Location:Ireland Remote

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

JOB SUMMARY

Amgen's Rare Disease Business Unit is seeking a technical expert. The successful candidate will be responsible for providing technical oversight in support of method related testing challenges, incoming method transfer and commercial investigations spanning various analytical platforms which may include Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, recombinant PEGylated proteins and bispecific T-cell engagers (“BiTEs”). Responsibilities also include supporting implementation of new analytical technology, DS and DP tech transfers. The successful candidate will be a part of a team at the interface with Quality, Manufacturing, Drug Substance and Drug Product Process Development, and Contract Manufacturing, liaising with the globa network to ensure that programs are progressed.

Rare Disease Principal Scientist Key Responsibilities:

  • Technical leadership in support of troubleshooting method related testing challenges, incoming method transfer and development/commercial investigations.

  • Independent authorship and management review of technical reports, variations and responses to analytical questions from health authorities

  • Implementing state-of-the-art and fit-for-purpose analytical methods for: in-process, release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions

  • Generating, analysing, and critical evaluation of analytical data to support product development investigations, method remediation and regulatory submissions

  • Supporting ASTLs (May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation

  • Duties may include establishing timelines, milestones, methodological approaches, expected results, necessary resources and communication to global cross-functional stakeholders

  • Keeping current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities.

Basic Qualifications

Doctorate degree and 2 years of scientific experience

OR

Master’s degree and 6 years of scientific experience

OR

Bachelor’s degree and 8 years of scientific experience

Preferred Qualifications

  • PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering

  • 5+ year’s pharmaceutical/biotech experience in process and product development and analytical method development

  • Deep understanding of product quality attributes and control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product.

  • Commanding knowledge of analytical methods/technologies such as Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays used to test diverse modalities including monoclonal and bispecific antibodies, recombinant PEGylated proteins and bispecific T-cell engagers (“BiTEs”),

  • Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing.

  • Strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.

  • Strong understanding of drug substance and drug product manufacturing processes

  • Experience with regulatory filings and commercial quality systems

  • Experience working closely with process engineers and quality control laboratories to generate and interpret analytical data to provide enhanced understanding and guidance around process understanding and control

  • Experience with QbD and PAT, as applied to pharmaceutical development

  • Experience managing and transferring commercial production and test methods

  • Experience managing a team

  • Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing and defending the Quality Target Product Profile

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