Process Development Scientist - Pivotal Attribute Sciences

Thousand Oaks, CA, US
Oct 28, 2020
Required Education
Bachelors Degree
Position Type
Full time
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 Pivotal PD organizations focus is developing and commercializing 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.

Located in our Thousand Oaks, CA office, the PD Scientist will work supporting product characterization / method development and as an Attribute Sciences Team lead/liaison for clinical candidate molecules in the pivotal stage of development.

Key responsibilities include:
  • Testing and characterization of protein products: Design and execute studies, interpret results, author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents.
  • Hands-on development, qualification, remediation, and transfer of analytical methods to Quality Control. Author technical protocols, reports and Standard Operating Procedures (SOPs) for analytical methods. Serve as analytical subject matter expert to support investigations and studies carried out by other functional areas.
  • 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.
  • Oversee the development and characterization of all methods used to test the product.
  • Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions and reference standard qualification.
  • Represent the Attribute Sciences department at all product delivery team meetings.
  • Closely collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.
  • Answer analytical and product quality questions from health authorities.
  • Providing expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.

Basic Qualifications

Doctorate degree
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience

Preferred Qualifications
  • M.S. in Biochemistry
  • Strong scientific background in biologics method development and product characterization
  • Ability to lead transversal project teams, previous managerial experience
  • 3+ years' experience in industrial analytical laboratories supporting method development and testing of commercial or clinical protein products
  • Demonstrated 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 mentorship to junior staff
  • Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects

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.

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.