25 days old

Process Development Senior Associate - Pivotal Drug Product Technology

Amgen
Cambridge, MA 02138
  • Job Code
    117462964
Amgen

Job ID: R-92260
Location: Cambridge, MA, US 02139

Amgen is currently seeking a Process Development Senior Associate for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen's drug product and process development.

Responsibilities:
  • Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics.
  • Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
  • Actively utilize advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
  • Create visualizations to enable business application of data analysis.
  • Explore and evaluate new digital tools and techniques to improve the team's developmental and operational capabilities.
  • As needed, provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
  • Support standardization and optimization of departmental practices by contributing to guideline documents.
  • Participate in global cross-functional teams working effectively in a highly matrixed team environment to progress product development.
  • Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.


Ability to travel domestically and internationally up to 10% of the time.

Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of scientific experience

OR

Associate degree and 6 years of scientific experience

OR

High school diploma / GED and 8 years of scientific experience

Preferred Qualifications:
  • Master's degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline.
  • 2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments.
  • Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down models, characterization, and scale up.
  • Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality.
  • Proficiency in at least one statistical software package (such as SIMCA or JMP).
  • Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function.
  • Strong problem solving and effective multi-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.

PI117462964

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92260<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>Amgen is currently seeking a Process Development Senior Associate for our Pivotal Drug Product Technologies Group in Cambridge, MA. This group is responsible for late stage drug product formulation and fill/finish process development for large molecule modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs), and fusion proteins). Working closely with a team of scientists and engineers, the successful candidate will apply scientific and engineering principles to advance the technical aspects of Amgen's drug product and process development.<br><br>Responsibilities:<br><ul><li>Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics.</li><li>Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.</li><li>Actively utilize advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.</li><li>Create visualizations to enable business application of data analysis.</li><li>Explore and evaluate new digital tools and techniques to improve the team's developmental and operational capabilities.</li><li>As needed, provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.</li><li>Support standardization and optimization of departmental practices by contributing to guideline documents.</li><li>Participate in global cross-functional teams working effectively in a highly matrixed team environment to progress product development.</li><li>Deliver progress reports and presentations to ensure management awareness and engagement of the current status, progress, and future program and functional needs.</li></ul><br><br>Ability to travel domestically and internationally up to 10% of the time.<br><br>Basic Qualifications:<br><br>Master's degree<br><br>OR<br><br>Bachelor's degree and 2 years of scientific experience<br><br>OR<br><br>Associate degree and 6 years of scientific experience<br><br>OR<br><br>High school diploma / GED and 8 years of scientific experience<br><br>Preferred Qualifications:<br><ul><li>Master's degree in Pharmaceutics, Biotechnology, Engineering, Material Science or related discipline.</li><li>2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers, statistical process control (SPC), and statistical design and analysis of experiments.</li><li>Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down models, characterization, and scale up.</li><li>Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality.</li><li>Proficiency in at least one statistical software package (such as SIMCA or JMP).</li><li>Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function.</li><li>Strong problem solving and effective multi-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/NaY4GAh6DgRnfRBOuqRMb"> <p>PI117462964</p>

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Posted: 2020-01-25 Expires: 2020-02-25

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Process Development Senior Associate - Pivotal Drug Product Technology

Amgen
Cambridge, MA 02138

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