Amgen Process Development Scientist in Cambridge, Massachusetts

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

Do you have passion for applying latest advances in analytical sciences to drive forward development of biological therapeutics and bring lifesaving medicines to the patients? Do you thrive in dynamic and fast-paced environment, like solving challenging problems and driving tasks to completion? If yes, this role can be a great fit for you.

There an exciting career opportunity to join the Pivotal Attribute Sciences team based in Amgen Cambridge, Massachusetts site. In this role you will:

Interface and collaborate with other functional areas in matrix environment as analytical subject matter expert to support and advise design of characterization studies, data analysis and investigations.

Monitor and leverage latest advances in protein analytics to develop, optimize, troubleshoot, remediate, qualify, validate and transfer analytical methods.

Execute characterization testing with advanced analytical methods including capillary electrophoresis, chromatography and mass spectrometry techniques.

Interpret results, author technical protocols, reports, analytical method descriptions and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.

Support development late stage development protein products as analytical team lead representing Attribute Sciences in cross-functional product delivery teams.

Basic Qualifications

Doctorate degree

OR

Master's degree and 4 years of Scientific experience

OR

Bachelor's degree and 6 years of Scientific experience

Preferred Qualifications

Expertise in capillary electrophoresis (CE), liquid chromatography (LC), mass spectrometry and protein chemistry, experience in working with protein therapeutics, including glycoproteins, experience in CE and LC method development and qualification.

Proficiency in solving complex problems, ability to work independently, proactively seek outside resources and collaborate, self-starter and team player with strong leadership and decision-making skills capable of providing guidance to junior staff.

Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects.

5+ years' experience in industrial analytical laboratories supporting characterization of protein therapeutics, including method development, qualification, transfer, validation and authoring technical documents. Experience in working with Quality Control laboratories to execute method transfers, validations and troubleshooting.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.