27 days old

Process Development Associate Scientist

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117523817
Amgen

Job ID: R-92431
Location: Thousand Oaks, CA, US 91360

Based in Thousand Oaks, CA, the role of Associate Scientist in Pivotal Drug Product Technologies will be to provide support for Amgen's biologics drug product and process design. The Associate Scientist will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. The candidate will integrate and utilize platform capabilities, prior product knowledge, and data analytics to advance Amgen practices and ensure success through the commercialization process.

Responsibilities include :
  • 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 Investigational New Drug (IND) and marketing application submissions
  • Actively utilize advanced Information Systems (IS) to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis
  • Explore and evaluate new digital tools and techniques to improve the team's developmental and operational capabilities
  • 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
  • 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 and 2 years of scientific or engineering experience

OR

Bachelor's degree and 4 years of scientific or engineering experience

Preferred Qualifications
  • Master's degree in Pharmaceutics, Biotechnology, Engineering or Chemistry
  • 4+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, analytical methods, technology transfers, and statistical design and analysis of experiments
  • Experience with characterization of drug product formulation and fill/finish unit operations (i.e. freeze/thaw, formulation, mixing, filtration, filling, and inspection)
  • Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality
  • Proficiency with statistical analyses (using software such as SIMCA or JMP)
  • Aseptic processing experience and familiarity with current Good Manufacturing Practices (cGMPs)
  • Regulatory filings and compliance issues for sterile injectable products
  • 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.

PI117523817

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92431<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Based in Thousand Oaks, CA, the role of Associate Scientist in Pivotal Drug Product Technologies will be to provide support for Amgen's biologics drug product and process design. The Associate Scientist will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. The candidate will integrate and utilize platform capabilities, prior product knowledge, and data analytics to advance Amgen practices and ensure success through the commercialization process.<br><br>Responsibilities include :<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 Investigational New Drug (IND) and marketing application submissions</li><li>Actively utilize advanced Information Systems (IS) to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis</li><li>Explore and evaluate new digital tools and techniques to improve the team's developmental and operational capabilities</li><li>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>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><li>Ability to travel domestically and internationally up to 10% of the time</li></ul><br><br><b>Basic Qualifications </b><br><br>Master's degree and 2 years of scientific or engineering experience<br><br>OR<br><br>Bachelor's degree and 4 years of scientific or engineering experience<br><br><b>Preferred Qualifications </b><br><ul><li>Master's degree in Pharmaceutics, Biotechnology, Engineering or Chemistry</li><li>4+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, analytical methods, technology transfers, and statistical design and analysis of experiments</li><li>Experience with characterization of drug product formulation and fill/finish unit operations (i.e. freeze/thaw, formulation, mixing, filtration, filling, and inspection)</li><li>Understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality</li><li>Proficiency with statistical analyses (using software such as SIMCA or JMP)</li><li>Aseptic processing experience and familiarity with current Good Manufacturing Practices (cGMPs)</li><li>Regulatory filings and compliance issues for sterile injectable products</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/ADz7w6CnpZXefEmjho6np"> <p>PI117523817</p>

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Posted: 2020-01-28 Expires: 2020-02-28

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Process Development Associate Scientist

Amgen
Thousand Oaks, CA 91360

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