1+ months

Sr. Associate- Biological Relevance and Characterization

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116491668
Amgen

Job ID: R-90379
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Sr. Associate- Biological Relevance and Characterization to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more:

The Sr. Associate - Biological Relevance and Characterization 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 include:

Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations

Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions

Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions

May participate or 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

Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities

Supporting analytical projects involving method development, qualification, and transfer

Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions

Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates and documentation.

Basic Qualifications:

Master's degree

Or

Bachelor's degree and 2 years of Scientific experience

Preferred Qualifications:

Experience in cell and tissue 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 SPR (Surface Plasma Resonance) techniques to run binding assays

Experience with flow cytometry

Awareness of regulatory filings (IND, BLA, and NDA) and ICH Guidelines

Innovation - positive approach to challenges; supports new ideas and initiatives; brings out and utilizes others' creativity to improve group performance

Client orientation- establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered

Communication and Interpersonal skills - communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs 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.

PI116491668

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90379<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a <b>Sr. Associate- Biological Relevance and Characterization</b> to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. To learn more: <br><br>The Sr. Associate - Biological Relevance and Characterization 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>Responsibilities include:<br><br>Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations<br><br>Preparing technical reports for investigations, product and impurity characterization, and regulatory submissions<br><br>Generating, analyzing, and interpreting analytical data to support: product development investigations, and regulatory submissions<br><br>May participate or 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<br><br>Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities<br><br>Supporting analytical projects involving method development, qualification, and transfer<br><br>Provides critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions<br><br>Participates in and contributes to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates and documentation.<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 and tissue 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 SPR (Surface Plasma Resonance) techniques to run binding assays<br><br>Experience with flow cytometry<br><br>Awareness of regulatory filings (IND, BLA, and NDA) and ICH Guidelines<br><br>Innovation - positive approach to challenges; supports new ideas and initiatives; brings out and utilizes others' creativity to improve group performance<br><br>Client orientation- establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered<br><br>Communication and Interpersonal skills - communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood<br><br><b> Amgen </b> provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow. <br><br><b> Amgen </b> focuses on areas of high unmet medical needs 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/Z4nEdRi124DbhxqmIbXn4"> <p>PI116491668</p>

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Posted: 2019-12-20 Expires: 2020-01-20

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Sr. Associate- Biological Relevance and Characterization

Amgen
Thousand Oaks, CA 91360

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