1+ months

Pivotal Drug Product Technologies-Process Development, Senior Associate

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117414510
Amgen

Job ID: R-91573
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Senior (Sr.) Associate, Pivotal Drug Product Technologies which will be based out of Amgen's Thousand Oaks, California facility. The role of the Sr. Associate in Pivotal Drug Product Technologies will be to provide support for Amgen's biologics drug product and process design. The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product commercialization and life-cycle management. The Sr. Associate will integrate and utilize platform capabilities, prior product knowledge, and data analytics/visualization to advance Amgen's pipeline and ensure success of the commercialization process.

In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world.

Primary responsibilities for this position will include the following:

  • Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development in support of commercialization and life cycle management of biologics
  • As needed, support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, vials, etc.)
  • Evaluate process and product performance through analytical testing, e.g. measurement of pH, conductivity, osmolality, protein concentration, SEC, CEX, particle concentration.
  • Conduct analysis of data generated from the above listed activities, including statistical analysis using JMP, SAS, etc.
  • Apply digital tools and techniques to automate data structuring, integration with electronic notebooks and analysis of large and diverse data-sets
  • Build clear, intuitive visualization tools (e.g. dashboards, charts, reports, apps) to streamline data analysis and enable actionable decision-making
  • C urate data and apply advanced data analytics (e.g. machine learning) to leverage automated capabilities and historical data in deriving novel insights
  • Support studies to characterize and enable implementation of new technologies that advance state-of-the art automation, high throughput screening and analytical capabilities
  • Author/review technical documents: technical protocols, technical reports and regulatory documents
  • Clearly and consistently communicate progress reports and presentations to ensure management and functional awareness of and engagement in the current status, plan forward, and forthcoming program needs
  • Operate in a fast-paced, matrixed environment
  • Collaborate successfully cross-functionally to progress product development in support of various modalities across the Amgen network


Basic Qualifications:

Master's Degree

OR

Bachelor's Degree and 2 years of Scientific, Engineering or Operations experience

Preferred Qualifications:

  • Degree in Engineering, Chemistry, Pharmaceutics, Materials Science, or related discipline
  • Familiarity with pharmaceutical/biotechnology process development
  • Aseptic processing experience and familiarity with cGMPs
  • 2+ years of experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, formulation development, equipment design and implementation, technology transfers
  • Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)
  • Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality
  • Knowledge of at least one statistical software package (e.g. SAS, JMP or Minitab)
  • Familiarity with programming (e.g. Python, R, MATLAB) and database languages (e.g. SQL), as well as data visualization tools (e.g. Tableau, Spotfire, D3js)
  • Interest in learning new techniques
  • Ability to perform multiple tasks simultaneously
  • Ability to shift priorities quickly while maintaining accurate records
  • Strong organizational skills with strong attention to detail
  • Strong critical thinking, analytical and problem solving skills
  • Excellent communication (oral and written)


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.

PI117414510

<b>Amgen</b><br/><br/><b>Job ID: </b>R-91573<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is seeking a Senior (Sr.) Associate, Pivotal Drug Product Technologies which will be based out of Amgen's Thousand Oaks, California facility. The role of the Sr. Associate in Pivotal Drug Product Technologies will be to provide support for Amgen's biologics drug product and process design. The Sr. Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product commercialization and life-cycle management. The Sr. Associate will integrate and utilize platform capabilities, prior product knowledge, and data analytics/visualization to advance Amgen's pipeline and ensure success of the commercialization process.<br><br>In our mission to serve patients, speed is absolutely critical. We're rapidly expanding our hiring initiatives and are excited to unite with the most passionate and brilliant scientific minds who want to join our team - working toward our mission of advancing high potential programs for cancer patients around the world.<br><br><b>Primary responsibilities for this position will include the following:</b><br><br><ul><li>Participate in the planning, design, execution, and documentation of studies related to drug product formulation and process development in support of commercialization and life cycle management of biologics</li><li>As needed, support and conduct related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, vials, etc.)</li><li>Evaluate process and product performance through analytical testing, e.g. measurement of pH, conductivity, osmolality, protein concentration, SEC, CEX, particle concentration.</li><li>Conduct analysis of data generated from the above listed activities, including statistical analysis using JMP, SAS, etc.<br></li><li>Apply digital tools and techniques to automate data structuring, integration with electronic notebooks and analysis of large and diverse data-sets<br></li><li> Build clear, intuitive visualization tools (e.g. dashboards, charts, reports, apps) to streamline data analysis and enable actionable decision-making <br></li><li> C urate data and apply advanced data analytics (e.g. machine learning) to leverage automated capabilities and historical data in deriving novel insights<br></li><li>Support studies to characterize and enable implementation of new technologies that advance state-of-the art automation, high throughput screening and analytical capabilities<br></li><li>Author/review technical documents: technical protocols, technical reports and regulatory documents<br></li><li>Clearly and consistently communicate progress reports and presentations to ensure management and functional awareness of and engagement in the current status, plan forward, and forthcoming program needs<br></li><li>Operate in a fast-paced, matrixed environment<br></li><li>Collaborate successfully cross-functionally to progress product development in support of various modalities across the Amgen network<br></li></ul><br><br><b>Basic Qualifications:</b><br><br>Master's Degree<br><br>OR<br><br>Bachelor's Degree and 2 years of Scientific, Engineering or Operations experience<br><br><b>Preferred Qualifications:</b><br><br><ul><li>Degree in Engineering, Chemistry, Pharmaceutics, Materials Science, or related discipline</li><li>Familiarity with pharmaceutical/biotechnology process development</li><li>Aseptic processing experience and familiarity with cGMPs</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</li><li>Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with relevant analytical techniques (i.e. SEC, CEX, HIAC, MFI)</li><li>Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality</li><li>Knowledge of at least one statistical software package (e.g. SAS, JMP or Minitab)</li><li>Familiarity 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>Interest in learning new techniques</li><li>Ability to perform multiple tasks simultaneously</li><li>Ability to shift priorities quickly while maintaining accurate records</li><li>Strong organizational skills with strong attention to detail</li><li>Strong critical thinking, analytical and problem solving skills</li><li>Excellent communication (oral and written)</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/Ma1YVMUDOpRwUoMyuQ5Jl"> <p>PI117414510</p>

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Posted: 2020-01-24 Expires: 2020-02-24

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Pivotal Drug Product Technologies-Process Development, Senior Associate

Amgen
Thousand Oaks, CA 91360

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