Amgen

Process development Scientist

Employer
Amgen
Location
Cambridge, MA, US
Posted
Aug 09, 2019
Ref
R-80846
Required Education
Bachelors Degree
Position Type
Full time
Amgen is seeking a Process development Scientist to join our team and work from Amgen's beautiful Cambridge, Mass campus. This is an exciting career opportunity to join the Pivotal Attribute Sciences team. In this role you will support development of late stage development biological therapeutic products as analytical team leader representing Attribute Sciences in cross-functional product delivery team.

Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The focus of Pivotal PD organization is to develop and commercialize robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers (BiTEs®), live oncolytic viruses, and synthetic medicines.

Key responsibilities include:

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.

Oversee the development and characterization of all methods used to test the product, with functional focus in separation sciences and mass spectrometry.

Drive 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 Chemistry, Manufacturing & Controls (CMC) sections in regulatory documents.

Lead 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.

Interface and collaborate 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.

Answer analytical and product quality questions from health authorities, participate in regulatory inspections and regulatory meetings.

Supervising or mentoring junior staff

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
  • PhD in Biochemistry, Chemistry or equivalent.
  • Ability to lead transversal project teams, as well as previous managerial experience
  • Strong scientific background in biologics method development and product characterization
  • Expertise in liquid chromatography (LC), mass spectrometry, biophysical and protein chemistry techniques. Experience in working with protein molecules, including glycoproteins, experience in method development and/or 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


Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs 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.

Join Us

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 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

Join Us

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.