27 days old

Process Development Scientist - Pivotal Attribute Sciences

Amgen
Cambridge, MA 02138
  • Job Code
    117524184
Amgen

Job ID: R-92270
Location: Cambridge, MA, US 02139

Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses.

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.

The successful Scientist candidate will design and carry out analytical experiments to support process and product characterization for pivotal and commercial and development products. He/she will utilize strong expertise in mass spectrometry and separation sciences to perform testing and characterization studies, as well as optimize analytical methods leveraging the latest advances in analytics.

Key responsibilities and requirements include:

Testing and characterization of protein and synthetic products: Design and execute studies, interpret results, author technical reports and analytical CMC sections in regulatory documents.

Analytical methods: Development, qualification, remediation, and transfer.

Author technical protocols, reports and SOPs for analytical methods.

Serve as analytical subject matter expert to support investigations and studies carried out by other functional areas.

Effectively interfacing and collaborating with other functional area colleagues within Process development to support and advise design of characterization studies, data analysis and communicating results.

Providing expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development Providing characterization results and/or authoring sections of Amgen's clinical trial and marketing applications, helping to refine Amgen's analytical regulatory strategies.

Basic Qualifications:

Doctorate degree or Doctorate degree completed by March 2020

OR

Master's degree and 4 years of scientific experience

OR

Bachelor's degree and 6 years of scientific experience

Preferred Qualifications:

Doctorate degree and 2+ years of industry related experience

Direct experience within an industrial laboratory performing methods development to support biologics quality testing.

Demonstrated expertise in mass spectrometry, liquid chromatography, and protein chemistry, including glycoproteins analysis, with a proven track record of successful LC and LC-MS method development.

Expertise in capillary electrophoresis.

Functional understanding of ICH and USP guidelines product quality.

Proven 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.

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.

PI117524184

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92270<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is a leading biotechnology company with a mission to serve patients around the world. As a science-based, patient-focused organization, we discover and develop innovative therapies to treat serious illnesses.<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>The successful Scientist candidate will design and carry out analytical experiments to support process and product characterization for pivotal and commercial and development products. He/she will utilize strong expertise in mass spectrometry and separation sciences to perform testing and characterization studies, as well as optimize analytical methods leveraging the latest advances in analytics.<br><br><b>Key responsibilities and requirements include:</b><br><br>Testing and characterization of protein and synthetic products: Design and execute studies, interpret results, author technical reports and analytical CMC sections in regulatory documents.<br><br>Analytical methods: Development, qualification, remediation, and transfer.<br><br>Author technical protocols, reports and SOPs for analytical methods.<br><br>Serve as analytical subject matter expert to support investigations and studies carried out by other functional areas.<br><br>Effectively interfacing and collaborating with other functional area colleagues within Process development to support and advise design of characterization studies, data analysis and communicating results.<br><br>Providing expertise and evaluation of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development Providing characterization results and/or authoring sections of Amgen's clinical trial and marketing applications, helping to refine Amgen's analytical regulatory strategies.<br><br><b>Basic Qualifications:</b><br><br>Doctorate degree or Doctorate degree completed by March 2020<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><br>Doctorate degree and 2+ years of industry related experience<br><br>Direct experience within an industrial laboratory performing methods development to support biologics quality testing.<br><br>Demonstrated expertise in mass spectrometry, liquid chromatography, and protein chemistry, including glycoproteins analysis, with a proven track record of successful LC and LC-MS method development.<br><br>Expertise in capillary electrophoresis.<br><br>Functional understanding of ICH and USP guidelines product quality.<br><br>Proven 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.<br><br>Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects.<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/xWEeYMHmeEERho6NuxWoB"> <p>PI117524184</p>

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Posted: 2020-01-28 Expires: 2020-02-28

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Process Development Scientist - Pivotal Attribute Sciences

Amgen
Cambridge, MA 02138

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