Process Development Senior Scientist – Attribute Sciences

Category: Process Development
Job ID: R-69377
Employment Type: Full time
Location: Ireland – Dublin
Posted Date: January 10, 2019

Process Development Senior Scientist – Attribute Sciences

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 Commercial Attribute Sciences group in Dun Laoghaire is seeking a Senior Scientist. The successful candidate will be responsible for providing technical leadership in support of troubleshooting method related issues, 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, bispecific T-cell engagers (“BiTEs”), synthetic peptides and live oncolytic viruses. Responsibilities also include supporting implementation of new analytical technology, incoming tech transfer, method transfer and commercial investigations. This individual will be a part of a team at the interface with Commercial Quality and Manufacturing, liaising with the global Attribute Sciences network to ensure that site needs are addressed.

Commercial Attribute Sciences Senior Scientist Key Responsibilities:

  • Technical leadership in support of troubleshooting method related issues, incoming method transfer and commercial investigations
  • Independent authorship technical reports and answers to analytical questions from health authorities
  • Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, investigations, and regulatory submissions
  • Generating, analyzing, and critical evaluation of analytical data to support product development investigations, and regulatory submissions
  • 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
  • Provides mentoring and expertise to less-experienced staff
  • Duties may include establishing timelines, milestones, methodological approaches, expected results, and necessary resources
  • Keeping current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities.

Basic Qualifications

Doctorate degree in life sciences or related discipline and 2 years of Scientific experience

OR

Master’s degree in life sciences or related discipline and 5 years of Scientific experience

OR

Bachelor’s degree in life sciences or related discipline and 7 years of Scientific experience

Preferred Qualifications

  • Proven technical leader with advanced understanding and experience with various analytical platforms such as Chromatography, CE, General Assays (e.g. pH, Osmolality, Karl Fisher titration, etc.), Gels, Bioassays and Immunoassays

  • Excellent written and oral communication skills for the timely and detail-oriented documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment
  • Experience in developing, implementing and commercializing methods for in-process, process characterization, and release testing
  • Experience with method qualification/validation

  • Communication – establishes and maintains effective communication mechanisms; works well in teams
  • Experience with cGMP and late stage programs

  • Experience with CMC authoring/development preferred
  • Expertise in cell culture and bioassays for the quantitative determination of biological activity of proteins is a plus

Amgen is an equal opportunities Employer

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