Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences 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 peoples lives.
Amgen's Commercial Attribute Sciences group in West Greenwich, Rhode Island is seeking a proven leader. The successful candidate will be responsible for leading a team of scientists to provide technical oversight in support of method related testing challenges, incoming method transfer and commercial investigations spanning various analytical platforms which may include chromatography, CE, DNA, and immunoassays used to test diverse modalities. Responsibilities also include supporting implementation of new analytical technology, incoming tech transfer, forensics for commercial manufacturing and Process Development investigations, analytical support for the Drug Substance Technology group and management of the Commercial Attribute Sciences laboratory. The successful candidate will be a part of a team at the interface with Quality, manufacturing, and Process Development, liaising with the global Attribute Sciences network to ensure that site needs are addressed. This leadership role of the Commercial Attribute Sciences team at Rhode Island will laisse with site leadership as well as Attribute Sciences functional leadership across Amgen.
Commercial Attribute Sciences Principal Scientist Key Responsibilities:
- Technical leadership in support of troubleshooting method related testing challenges, incoming method transfers and commercial investigations.
- Management of the AS analytical laboratory, including prioritizing work across a wide range of customers.
- Work closely with process engineers and quality control laboratories to generate and interpret analytical data to provide guidance around process understanding and control.
- Independent authorship and management review of technical reports, variations and responses to analytical questions from health authorities.
- ASTL support, may participate or contribute to critical analytical development teams (e.g., Product Delivery Teams, Process Development or Product Quality teams).
- Implement state-of-the-art and fit-for-purpose analytical methods to asses attributes for: release testing, stability testing, process characterization/optimization, investigations, and regulatory submissions.
- Generate, analyze, and critically evaluate analytical data to support process development investigations, method remediation and regulatory submissions.
- Support career development and mentor staff.
- Duties may include establishing timelines, milestones, methodological approaches, expected results, necessary resources and communication to global cross-functional stakeholders.
- Keep current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities.
Doctorate degree and 3 years of scientific experience
Masters degree and 6 years of scientific experience
Bachelors degree and 8 years of scientific experience
- PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
- 5+ years 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, DNA and immunoassays used to test diverse modalities, including monoclonal and bispecific antibodies, and other proteins.
- 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 manufacturing processes.
- Experience with regulatory filings and commercial quality systems.
- Experience managing a team in a cross-functional environment.
- Experience managing and transferring commercial production and test methods.
- Strong communication skills and ability to provide cross-functional leadership.
- Experience in applying troubleshooting and investigation methodologies for problem solving. This includes technical support for deviation investigations and other commercial support activities.
- Familiarity with forensics investigations and analysis.
Amgen is an Equal opportunities employer
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.