30 days old

Process Development Sr Associate

Amgen
Cambridge, MA 02138
  • Job Code
    116523036
Amgen

Job ID: R-90351
Location: Cambridge, MA, US 02139

Amgen is seeking a Process Development Sr. Associate to join our team and work from Amgen's beautiful Cambridge, MA, campus. To learn more:

This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative assays for the measurement of DNA, proteins and other biological analytes for manufacturing process development.

Responsibilities include:

Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: impurity release testing.

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.

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

Basic Qualifications:

Master's degree

OR

Bachelor's degree & 2 years of Scientific experience

Preferred Qualifications:

Experience and expertise with molecular biology, particularly qPCR and DNA isolation.

Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.

Experience with automation platforms, specifically large scale liquid handlers

Experience and expertise with the use of electronic notebooks, as well as Microsoft Office software, particularly Word, PowerPoint and Excel

Experience working in a GMP regulated environment, as well as with regulatory filings (IND, BLA, and NDA) and ICH Guidelines

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

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

Communication - establishes and maintains effective communication mechanisms to keep staff appropriately informed; bridges communication between individuals, units and other organizations as necessary

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

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.

A mgen 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.

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.

PI116523036

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90351<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is seeking a <b>Process Development Sr. Associate </b> to join our team and work from Amgen's beautiful Cambridge, MA, campus. To learn more: <br><br>This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative assays for the measurement of DNA, proteins and other biological analytes for manufacturing process development.<br><br>Responsibilities include:<br><br>Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: impurity release testing.<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>Providing critical evaluation of analytical data and results to support: product development (for Process Development, Quality, etc.), investigations and regulatory submissions<br><br><b>Basic Qualifications:</b><br><br>Master's degree<br><br>OR<br><br>Bachelor's degree & 2 years of Scientific experience<br><br><b>Preferred Qualifications:</b><br><br>Experience and expertise with molecular biology, particularly qPCR and DNA isolation.<br><br>Experience and expertise with protein assays, particularly ELISA as well as most common formats for measuring protein-protein interactions.<br><br>Experience with automation platforms, specifically large scale liquid handlers<br><br>Experience and expertise with the use of electronic notebooks, as well as Microsoft Office software, particularly Word, PowerPoint and Excel<br><br>Experience working in a GMP regulated environment, as well as with regulatory filings (IND, BLA, and NDA) and ICH Guidelines<br><br>Innovation - positive approach to challenges; champions new ideas and initiatives; brings out and utilizes others' creativity to improve unit 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 - establishes and maintains effective communication mechanisms to keep staff appropriately informed; bridges communication between individuals, units and other organizations as necessary<br><br>Interpersonal skills - communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood<br><br><b>Amgen </b>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><b>Amgen</b> 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>A<b> mgen </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>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/r7PxNwhD4OQzS2p4fz2pW"> <p>PI116523036</p>
Posted: 2019-12-21 Expires: 2020-01-21

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Process Development Sr Associate

Amgen
Cambridge, MA 02138

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