30 days old

Process Development Scientist

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117588623
Amgen

Job ID: R-92308
Location: Thousand Oaks, CA, US 91360

Amgen is currently seeking a Scientist in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for pivotal phase analytical development, including method development, qualification and transfer, as well as process and product development and characterization support.

The Scientist will work in a matrix environment with a team responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for biologic manufacturing processes and products. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from First-In-Human (FIH) study through to marketing application.

Responsibilities:
  • 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 of late stage protein products as analytical team lead representing Attribute Sciences in cross-functional product delivery teams.
  • Collaborate closely with drug substance and drug product process development colleagues.


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 or Biophysics
  • 2+ year's post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.
  • Expertise in capillary liquid chromatography (LC), electrophoresis (CE), mass spectrometry and protein chemistry.
  • Developing and implementing methods for in-process testing, release and stability testing.
  • Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner.
  • Self-starter and team player with strong leadership and decision-making skills capable of providing guidance to junior staff.
  • Works well in cross-functional teams, and across various geographic locations in different time zones.
  • Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents.


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.

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.

PI117588623

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92308<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is currently seeking a Scientist in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This group is responsible for pivotal phase analytical development, including method development, qualification and transfer, as well as process and product development and characterization support.<br><br>The Scientist will work in a matrix environment with a team responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for biologic manufacturing processes and products. The Scientist will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from First-In-Human (FIH) study through to marketing application.<br><br><b>Responsibilities:</b><br><ul><li>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.</li><li>Monitor and leverage latest advances in protein analytics to develop, optimize, troubleshoot, remediate, qualify, validate and transfer analytical methods.</li><li>Execute characterization testing with advanced analytical methods including capillary electrophoresis, chromatography and mass spectrometry techniques.</li><li>Interpret results, author technical protocols, reports, analytical method descriptions and analytical Chemistry, Manufacturing, and Controls (CMC) sections in regulatory documents.</li><li>Support development of late stage protein products as analytical team lead representing Attribute Sciences in cross-functional product delivery teams.</li><li>Collaborate closely with drug substance and drug product process development colleagues.</li></ul><br><br><b>Basic Qualifications </b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 4 years of scientific experience<br><br>OR<br><br>Bachelor's degree and 6 years of scientific experience<br><br><b>Preferred Qualifications </b><br><ul><li>PhD in Biochemistry or Biophysics</li><li>2+ year's post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development.</li><li> Expertise in capillary liquid chromatography (LC), electrophoresis (CE), mass spectrometry and protein chemistry. </li><li>Developing and implementing methods for in-process testing, release and stability testing.</li><li>Solid understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) requirements and their application in a phase appropriate manner.</li><li> Self-starter and team player with strong leadership and decision-making skills capable of providing guidance to junior staff. </li><li>Works well in cross-functional teams, and across various geographic locations in different time zones.</li><li>Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents.</li></ul><br><br>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.<br><br>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.<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/r7EyEVUDgxkDT2p4fz2pW"> <p>PI117588623</p>

Categories

Posted: 2020-01-30 Expires: 2020-03-01

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Process Development Scientist

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast