30 days old

Process Development Scientist - Attribute Sciences Team Lead

Amgen
Cambridge, MA 02138
  • Job Code
    117524165
Amgen

Job ID: R-92278
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 modalities, and synthetic medicines.

There an exciting career opportunity to join the Pivotal Attribute Sciences team based in Amgen Cambridge, Massachusetts site. In this role of Scientist you will support development of late stage development biological therapeutic products as analytical team leader representing Attribute Sciences in cross-functional product delivery teams.

This role includes:

Lead program-oriented Attribute Sciences matrix analytical teams and ensuring that project deliverables are appropriately planned, executed and communicated to cross-functional partners.

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.

Provide expertise for continuous development of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.

Oversee the development and characterization of all methods used to test the product, with functional focus in separation sciences and mass spectrometry.

Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification.

Interpret results, author technical protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents.

Represent the Attribute Sciences department at product delivery team meetings.

Interface and collaborate with other functional areas in matrix environment, serving as analytical subject matter expert to support and advise design of characterization studies, data analysis and investigations.

Answer analytical and product quality questions from health authorities, participate in regulatory inspections and regulatory meetings.

Supervising or mentoring junior staff

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:

Doctorate Degree in Biochemistry or related field

Ability to lead transversal project teams

Strong scientific background in protein biologics methods development and product characterization. Functional understanding of GMP and a strong understanding of ICH Quality and USP regulations

Direct contributions toward regulatory filings and responses to regulatory questions

Demonstrated proficiency in solving complex problems, ability to work independently and proactively seek collaboration, a self-starter and team player with strong leadership and decision-making skills

Proficiency in mentoring junior staff

Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects, strong organizational skills

Expertise in liquid chromatography, protein chemistry and mass spectrometry of protein molecules, including glycoproteins, experience in LC and LC-MS method development and qualification

Good functional understanding and demonstrated proficiency in basic biochemical methods (ELISA, electrophoresis, UV/Vis spectroscopy), biophysical methods (analytical centrifugation, circular dichroism spectroscopy), and biological/functional methods (surface plasmon resonance, bioassays)

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.

PI117524165

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92278<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 modalities, and synthetic medicines.<br><br>There an exciting career opportunity to join the Pivotal Attribute Sciences team based in Amgen Cambridge, Massachusetts site. In this role of Scientist you will support development of late stage development biological therapeutic products as analytical team leader representing Attribute Sciences in cross-functional product delivery teams.<br><br><b>This role includes:</b><br><br>Lead program-oriented Attribute Sciences matrix analytical teams and ensuring that project deliverables are appropriately planned, executed and communicated to cross-functional partners.<br><br>Determining clinical product critical quality attributes through risk assessment, and defining the product quality target product profile to define process development.<br><br>Defining the analytical target profile for the methods used to monitor product quality.<br><br>Provide expertise for continuous development of Amgen's platform and analytical technologies, helping to drive innovation and efficiency within Process Development.<br><br>Oversee the development and characterization of all methods used to test the product, with functional focus in separation sciences and mass spectrometry.<br><br>Drive product characterization in support of process comparability studies, regulatory filings, regulatory questions, and reference standard qualification.<br><br>Interpret results, author technical protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents.<br><br>Represent the Attribute Sciences department at product delivery team meetings.<br><br>Interface and collaborate with other functional areas in matrix environment, serving as analytical subject matter expert to support and advise design of characterization studies, data analysis and investigations.<br><br>Answer analytical and product quality questions from health authorities, participate in regulatory inspections and regulatory meetings.<br><br>Supervising or mentoring junior staff<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><br>Doctorate Degree in Biochemistry or related field<br><br>Ability to lead transversal project teams<br><br>Strong scientific background in protein biologics methods development and product characterization. Functional understanding of GMP and a strong understanding of ICH Quality and USP regulations<br><br>Direct contributions toward regulatory filings and responses to regulatory questions<br><br>Demonstrated proficiency in solving complex problems, ability to work independently and proactively seek collaboration, a self-starter and team player with strong leadership and decision-making skills<br><br>Proficiency in mentoring junior staff<br><br>Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects, strong organizational skills<br><br>Expertise in liquid chromatography, protein chemistry and mass spectrometry of protein molecules, including glycoproteins, experience in LC and LC-MS method development and qualification<br><br>Good functional understanding and demonstrated proficiency in basic biochemical methods (ELISA, electrophoresis, UV/Vis spectroscopy), biophysical methods (analytical centrifugation, circular dichroism spectroscopy), and biological/functional methods (surface plasmon resonance, bioassays)<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/PdnVXgiogZXKSMNmTPXLW"> <p>PI117524165</p>

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

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Process Development Scientist - Attribute Sciences Team Lead

Amgen
Cambridge, MA 02138

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