30 days old

Senior Scientist- Process Development

Amgen
Cambridge, MA 02138
  • Job Code
    116522568
Amgen

Job ID: R-90202
Location: Cambridge, MA, US 02139

Amgen is currently seeking a Process Development Senior Scientist for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage biologics drug product formulation and fill/finish process development. The Senior Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.

Responsibilities:
  • Lead cross-functional Drug Product Commercialization Teams responsible for formulation development, fill/finish process development/characterization, technology transfer, and regulatory authoring for pipeline and lifecycle management projects.
  • Oversee and participate in the planning, design, execution, and documentation of formulation and fill/finish process development studies.
  • Manage a team of engineers and scientists to advance program and functional objectives.
  • Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships.
  • Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of INDa and marketing application submissions.
  • Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
  • Serve as subject matter expert in drug product technologies and help drive best practices and technical advancements.
  • Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, strategy and future program and functional needs.
  • Expand the utilization of advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
  • Ability to travel domestically and internationally up to 10% of the time.


Basic Qualifications:

Doctorate degree and 2 years of scientific experience

OR

Master's degree and 5 years of scientific experience

OR

Bachelor's degree and 7 years of scientific experience

Preferred Qualifications:
  • Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related discipline
  • 5+ years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring
  • Leadership of highly technical experts with demonstrated results driving forward pipeline and lifecycle management programs
  • Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems
  • Experience participating and leading global cross-functional teams
  • Superior knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings
  • Strong problem solving and effective cross-functional communication skills
  • Proven ability to learn and act on dynamic information at a rapid pace


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.

PI116522568

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90202<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is currently seeking a Process Development Senior Scientist for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage biologics drug product formulation and fill/finish process development. The Senior Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.<br><br>Responsibilities:<br><ul><li>Lead cross-functional Drug Product Commercialization Teams responsible for formulation development, fill/finish process development/characterization, technology transfer, and regulatory authoring for pipeline and lifecycle management projects.</li><li>Oversee and participate in the planning, design, execution, and documentation of formulation and fill/finish process development studies.</li><li>Manage a team of engineers and scientists to advance program and functional objectives.</li><li>Participate and lead global cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships.</li><li>Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of INDa and marketing application submissions.</li><li>Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.</li><li>Serve as subject matter expert in drug product technologies and help drive best practices and technical advancements.</li><li>Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, strategy and future program and functional needs.</li><li>Expand the utilization of advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.</li><li>Ability to travel domestically and internationally up to 10% of the time.</li></ul><br><br>Basic Qualifications: <br><br>Doctorate degree and 2 years of scientific experience<br><br>OR<br><br>Master's degree and 5 years of scientific experience<br><br>OR<br><br>Bachelor's degree and 7 years of scientific experience<br><br>Preferred Qualifications: <br><ul><li>Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related discipline</li><li>5+ years of experience that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring</li><li>Leadership of highly technical experts with demonstrated results driving forward pipeline and lifecycle management programs</li><li>Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems</li><li>Experience participating and leading global cross-functional teams</li><li>Superior knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings</li><li>Strong problem solving and effective cross-functional communication skills</li><li>Proven ability to learn and act on dynamic information at a rapid pace</li></ul><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/ADJ8Z2Tndb2DiEmjho6np"> <p>PI116522568</p>
Posted: 2019-12-21 Expires: 2020-01-21

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior Scientist- Process Development

Amgen
Cambridge, MA 02138

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast