Amgen

Principal Scientist

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Sep 30, 2021
Ref
R-128783
Required Education
Bachelors Degree
Position Type
Full time

Amgen's Pre-pivotal Attribute Sciences g0roup in Thousand Oaks, CA is seeking a leader. The successful candidate will be responsible for leading a team of scientists to support development of early stage protein therapeutics products. Responsibilities include but not limited to:

  • Representing Attribute Sciences in the project team for FIH development; Ensuring analytical activities are appropriately planned, executed and communicated to cross-functional partners
  • Leading and coordinating the development and qualification of all methods used to test the product, with functional focus in separation sciences and/or mass spectrometry
  • Determining critical product quality attributes and establishing appropriate control strategy
  • Responsible for setting specification for clinical product release and designing stability study in support of product expiry
  • Leading all aspects of reference standard qualification and product characterization in support of regulatory filings
  • Authoring technical protocols, reports, analytical methods, CMC sections in regulatory filing documents and response to questions from health authorities
  • Acting as Product Quality lead to assist with deviation impact assessment and investigation occurred during the GMP manufacturing and testing of clinical products
  • Interfacing and collaborating with other functional areas in matrix environment, serving as analytical subject matter expert to provide support and advise for process decisions
  • Driving for continuous improvement in analytical technologies, product characterization strategies, innovation and efficiency within the department
Basic Qualifications

Doctorate degree and 3 years of scientific experience

OR

Masters degree & 6 years of scientific experience

OR

Bachelors degree & 8 years of scientific experience

Preferred Qualifications

  • PhD in Biochemistry or related field and 5+ years experience in Biotech or Biopharmaceutical industry with lab experience
  • Working knowledge in product specification, stability study design and execution
  • Excellent verbal, written communication skills and technical writing skills including authorship for regulatory filings
  • Deep understanding of product quality attribute and strong trouble shooting skills to solve product related technical issues
  • Broad understanding of analytical methods used for product release and characterization with strong expertise in separation technology such as liquid chromatography, capillary electrophoresis and/or mass spectrometry
  • Ability to represent functional area in cross-functional teams
  • Excellent leadership skills and ability to lead team and mentor staff
  • Critical thinking and strategy approach in solving sophisticated problems

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.

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.