10 days old

Process Development Scientist

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117896394
Amgen

Job ID: R-93108
Location: Thousand Oaks, CA, US 91360

Amgen is currently seeking a Process Development Scientist in Pivotal Drug Product Technologies at its headquarters in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and process development for biologics modalities. The Scientist will provide technical and project leadership, integrating effective cross functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgen's pipeline.

Primary responsibilities for this role include:
  • Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management
  • Design, plan, execute, and document formulation and process development studies
  • Apply scientific/engineering principles and techniques, including modeling, to develop, characterize and implement processes and to solve technical challenges
  • Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions
  • Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
  • Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
  • Effectively and consistently communicate with management, cross-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs
  • Ability to travel domestically and internationally up to 10% of the time


Basic Qualifications:

  • Doctorate degree or Doctorate degree completed by April 2020


OR
  • Master's degree and 4 years of scientific experience


OR
  • Bachelor's degree and 6 years of scientific experience


Preferred Qualifications:
  • Advanced degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Pharmaceutics or related discipline
  • Experience in pharmaceutical development and manufacturing
  • Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments
  • Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
  • Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
  • Critical thinking, problem solving and independent research skills
  • Strong project management skills, including the ability to manage one's project resources (material, manpower, time, etc.)
  • Good organizational skills with strong attention to detail
  • Strong ability to operate well in a fast-paced, matrix environment and collaborate successfully cross-functionally


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.

PI117896394

<b>Amgen</b><br/><br/><b>Job ID: </b>R-93108<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is currently seeking a Process Development Scientist in Pivotal Drug Product Technologies at its headquarters in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and process development for biologics modalities. The Scientist will provide technical and project leadership, integrating effective cross functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgen's pipeline.<br><br>Primary responsibilities for this role include:<br><ul><li>Participate in Drug Product Commercialization Teams responsible for conducting process development of pipeline products and for supporting commercial products through lifecycle management</li><li>Design, plan, execute, and document formulation and process development studies</li><li>Apply scientific/engineering principles and techniques, including modeling, to develop, characterize and implement processes and to solve technical challenges</li><li>Apply advanced statistical/data analytics techniques to draw conclusions and inform decisions</li><li>Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations</li><li>Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions</li><li>Effectively and consistently communicate with management, cross-functional partners and relevant stakeholders on progress towards milestones and forthcoming program needs</li><li>Ability to travel domestically and internationally up to 10% of the time</li></ul><br><br>Basic Qualifications:<br><br><ul><li>Doctorate degree or Doctorate degree completed by April 2020</li></ul><br><br>OR<br><ul><li>Master's degree and 4 years of scientific experience</li></ul><br><br>OR<br><ul><li>Bachelor's degree and 6 years of scientific experience</li></ul><br><br>Preferred Qualifications:<br><ul><li>Advanced degree in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, Chemistry, Pharmaceutics or related discipline</li><li>Experience in pharmaceutical development and manufacturing</li><li>Experience in biologics process development, formulation development, fill-finish process engineering, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments</li><li>Experience with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)</li><li>Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)</li><li>Critical thinking, problem solving and independent research skills</li><li>Strong project management skills, including the ability to manage one's project resources (material, manpower, time, etc.)</li><li>Good organizational skills with strong attention to detail</li><li>Strong ability to operate well in a fast-paced, matrix environment and collaborate successfully cross-functionally</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/m6DY6NuM1EGVhKlqs4m2Z"> <p>PI117896394</p>

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Posted: 2020-02-08 Expires: 2020-03-10

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Process Development Scientist

Amgen
Thousand Oaks, CA 91360

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