Job ID: R-105495 Location: Cambridge, MA, US 02139
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.
There an exciting new career opportunity to join the Pivotal Attribute Sciences team based in Amgen Cambridge, Massachusetts site. In this role you will support development of late stage development protein products including:
Leading program-oriented Attribute Sciences matrix analytical team and ensuring that project deliverables are appropriately planned, executed and communicated to cross-functional partners. Represent the Attribute Sciences department at product delivery team meetings.
Determining clinical product critical quality attributes through risk assessment, and defining the product quality target product profile to define process development.
Defining the analytical target profile for the methods used to monitor product quality. Provide expertise for continuous development of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.
Overseeing the development and characterization of all methods used to test the product, with functional focus in separation sciences and mass spectrometry.
Driving product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification. Interpret results, author technical protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents. Answer analytical and product quality questions from health authorities, participate in regulatory inspections and regulatory meetings.
Interfacing and collaborating with other functional areas in matrix environment, serving as analytical subject matter expert to support and advise design of characterization studies, data analysis and investigations
Supervising or mentoring junior staff
Doctorate degree and 3 years of scientific experience
Master's degree & 6 years of scientific experience
Bachelor's degree & 8 years of scientific experience
PhD in Biochemistry or related field
10+ years' experience in industrial analytical laboratories
Ability to lead transversal project teams, as well as previous managerial experience
Experience in late stage analytical development of protein therapeutics, including regulatory filings and interactions with regulatory agencies
Advanced expertise in liquid chromatography, protein chemistry and mass spectrometry of protein molecules, including glycoproteins, experience in LC and LC-MS method development, qualification and validation
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 involving multiple cross-functional partners
If 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.PI124662447