16 days old

Associate Scientist Attribute Sciences

Amgen
Cambridge, MA 02138
  • Job Code
    115164339
Amgen

Job ID: R-87111
Location: Cambridge, MA, US 02139

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 Cambridge, MA office, the PD Associate Scientist will work supporting method development and product characterization for clinical candidate molecules in the pivotal stage of development.

Key responsibilities include:
  • 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.
  • Testing and characterization of protein and synthetic products to support Drug Substance and Drug Product process development, and to support regulatory filings. Execute studies, interpret results, author technical reports
  • Perform forced degradation studies to support product characterization, understanding of product stability, and evaluation of product comparability.
  • 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

Master's degree and 2 years of scientific experience
OR
Bachelor's degree and 4 years of scientific experience

Preferred Qualifications
  • B.S. in Biochemistry or related field
  • Good general biochemistry laboratory skills
  • Expertise in chromatography including HPLC, UPLC, and CE
  • Experience performing mass spectrometry
  • Strong desire to learn and interest in science
  • Demonstrated proficiency in method development and experience with method technology transfer
  • Understanding of phase-appropriate GMP compliance and documentation
  • Strong technical writing skills
  • Well-organized; ability to multitask, effectively plan and follow through on complex projects, and to work both independently and in teams


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.

PI115164339

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87111<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>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.<br><br>Located in our Cambridge, MA office, the PD Associate Scientist will work supporting method development and product characterization for clinical candidate molecules in the pivotal stage of development.<br><br>Key responsibilities include:<br><ul><li>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.</li><li>Testing and characterization of protein and synthetic products to support Drug Substance and Drug Product process development, and to support regulatory filings. Execute studies, interpret results, author technical reports</li><li>Perform forced degradation studies to support product characterization, understanding of product stability, and evaluation of product comparability.</li><li>Closely collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications.</li><li>Answer analytical and product quality questions from health authorities.</li><li>Providing expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.</li></ul><br><br><b> Basic Qualifications </b><br><br> Master's degree and 2 years of scientific experience <br> OR <br> Bachelor's degree and 4 years of scientific experience <br><br><b> Preferred Qualifications </b><br><ul><li>B.S. in Biochemistry or related field</li><li>Good general biochemistry laboratory skills</li><li>Expertise in chromatography including HPLC, UPLC, and CE</li><li>Experience performing mass spectrometry</li><li>Strong desire to learn and interest in science</li><li>Demonstrated proficiency in method development and experience with method technology transfer</li><li>Understanding of phase-appropriate GMP compliance and documentation</li><li>Strong technical writing skills</li><li>Well-organized; ability to multitask, effectively plan and follow through on complex projects, and to work both independently and in teams</li></ul><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/nVrVr7cY8r8dtExahwO6l"> <p>PI115164339</p>

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Posted: 2019-11-05 Expires: 2019-12-06

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Associate Scientist Attribute Sciences

Amgen
Cambridge, MA 02138

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