28 days old

Process Development Sr Associate: Biological Relevance and Characterization

Amgen
Cambridge, MA 02138
  • Job Code
    118833243
Amgen

Job ID: R-95454
Location: Cambridge, MA, US 02139

Amgen is seeking a Senior Associate-Biological Relevance and Characterization to join our team and work from Amgen's beautiful Cambridge, MA campus.

This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions.

Responsibilities :
  • Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations
  • Providing data to support technical reports for investigations, product and impurity characterization, and regulatory submissions
  • Generating and analyzing analytical data to support: product development investigations, and regulatory submissions
  • May contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
  • Develops and enhances scientific and technical skills
  • Supporting analytical projects involving method development, qualification, and transfer


Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 years of scientific experience

Preferred Qualifications

Experience in cell culture and cell biology techniques for quantitative determination of biological activity of proteins

Experience in cell-based bioassay development (method characterization, qualification, validation, technical transfer)

Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies

Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines

Detail oriented and excellent documentation skills

Experience with automated liquid handling

Innovation -supports new ideas and initiatives

Client orientation- establishes effective and responsive relationships with all clients

Communication and Interpersonal skills - communicate effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams

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.

PI118833243

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95454<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is seeking a <b>Senior Associate-Biological Relevance and Characterization</b> to join our team and work from Amgen's beautiful Cambridge, MA campus. <br><br>This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions.<br><br><b> Responsibilities </b>:<br><ul><li>Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations</li><li>Providing data to support technical reports for investigations, product and impurity characterization, and regulatory submissions</li><li>Generating and analyzing analytical data to support: product development investigations, and regulatory submissions</li><li>May contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation</li><li>Develops and enhances scientific and technical skills</li><li>Supporting analytical projects involving method development, qualification, and transfer</li></ul><br><br><b>Basic Qualifications </b><br><br>Master's degree<br><br>OR<br><br>Bachelor's degree and 2 years of scientific experience<br><br><b>Preferred Qualifications </b><br><br>Experience in cell culture and cell biology techniques for quantitative determination of biological activity of proteins<br><br>Experience in cell-based bioassay development (method characterization, qualification, validation, technical transfer)<br><br>Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies<br><br>Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines<br><br>Detail oriented and excellent documentation skills<br><br>Experience with automated liquid handling<br><br>Innovation -supports new ideas and initiatives<br><br>Client orientation- establishes effective and responsive relationships with all clients<br><br>Communication and Interpersonal skills - communicate effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood; works well in teams<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/7edWWMtnnM8VfZ1NF7Y5y"> <p>PI118833243</p>

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Posted: 2020-03-07 Expires: 2020-04-07

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Process Development Sr Associate: Biological Relevance and Characterization

Amgen
Cambridge, MA 02138

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