11 days old

Senior Associate

Amgen
Thousand Oaks, CA 91360
  • Job Code
    119286557
Amgen

Job ID: R-96638
Location: Thousand Oaks, CA, US 91360

Amgen is committed and dedicated to unlocking the potential of biology for patients suffering from serious illness in areas of high unmet medical need by discovering, developing, manufacturing and delivering innovative human therapeutics.

Based at Amgen's headquarters in Thousand Oaks, CA, the role of Sr. Associate in Pivotal Drug Product Technologies will be to provide support for Amgen's biologics drug product and process design.

The Senior Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product commercialization and lifecycle management. Additionally, this individual will integrate and utilize platform capabilities and data analytics/visualization to advance Amgen's pipeline and ensure success of the commercialization process.

The Sr. Associate will operate in a fast-paced, matrixed environment and collaborate cross-functionally to progress product development in support of various modalities across the Amgen network.

Responsibilities will include:

  • Participating in the planning, design, implementation, and documentation of studies related to drug product formulation and process development, in support of commercialization and life cycle management of biologics.
  • Supporting and conducting related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).
  • Evaluating process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization (cake appearance, moisture, reconstitution time), and particle quantitation/characterization.

Providing support for clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
  • Conducting analysis of data generated from the above listed activities, including statistical analysis using JMP, SAS, etc.
  • Applying digital tools and techniques to automate data structuring, integration with electronic notebooks and analysis of large and diverse datasets.
  • Authoring/reviewing technical documents (technical protocols, technical reports, regulatory documents, etc.)
  • Clearly, consistently and effectively communicating progress reports and presentations to ensure management and functional awareness of/engagement in current status, plan forward, and forthcoming program needs.
  • Participating with cross-functional teams within a fast-paced environment to progress initiatives.
  • 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 subject area.
  • Aseptic processing experience and familiarity with cGMPs.
  • 2+ years experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, and formulation development.
  • Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with pertinent analytical techniques (i.e. SEC, CEX, CE, HIAC, MFI).
  • Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality.
  • Experience with regulatory filings and compliance issues
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, adhere to instructions, and follow company policies.
  • Self-motivation, adaptability and a positive attitude.
  • Critical thinking, problem solving and independent research skills.
  • Good organizational skills with strong attention to detail.
  • Excellent communication (oral and written).


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.

PI119286557

<b>Amgen</b><br/><br/><b>Job ID: </b>R-96638<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is committed and dedicated to unlocking the potential of biology for patients suffering from serious illness in areas of high unmet medical need by discovering, developing, manufacturing and delivering innovative human therapeutics.<br><br>Based at Amgen's headquarters in Thousand Oaks, CA, the role of Sr. Associate in Pivotal Drug Product Technologies will be to provide support for Amgen's biologics drug product and process design.<br><br>The Senior Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product commercialization and lifecycle management. Additionally, this individual will integrate and utilize platform capabilities and data analytics/visualization to advance Amgen's pipeline and ensure success of the commercialization process.<br><br>The Sr. Associate will operate in a fast-paced, matrixed environment and collaborate cross-functionally to progress product development in support of various modalities across the Amgen network.<br><br><b><b>Responsibilities will include:</b></b><br><br><ul><li>Participating in the planning, design, implementation, and documentation of studies related to drug product formulation and process development, in support of commercialization and life cycle management of biologics.</li><li>Supporting and conducting related studies, e.g. UF/DF, filtration, freeze/thaw and fill/finish, for products in various formulations and formats (liquid, lyophilized, etc.).</li><li>Evaluating process and product performance through analytical testing via measurement of pH, conductivity, osmolality, protein concentration, HPLC and CE methodologies, solid state characterization (cake appearance, moisture, reconstitution time), and particle quantitation/characterization.</li></ul><br>Providing support for clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements<br><ul><li>Conducting analysis of data generated from the above listed activities, including statistical analysis using JMP, SAS, etc.</li><li>Applying digital tools and techniques to automate data structuring, integration with electronic notebooks and analysis of large and diverse datasets.</li><li>Authoring/reviewing technical documents (technical protocols, technical reports, regulatory documents, etc.)</li><li>Clearly, consistently and effectively communicating progress reports and presentations to ensure management and functional awareness of/engagement in current status, plan forward, and forthcoming program needs.</li><li>Participating with cross-functional teams within a fast-paced environment to progress initiatives.</li><li><b>Basic Qualifications:</b></li><li>Master's Degree</li><li>OR</li><li>Bachelor's Degree and 2 years of Scientific, Engineering or Operations experience</li><li><b>Preferred Qualifications:</b></li><li>Degree in Engineering, Chemistry, Pharmaceutics, Materials Science, or related subject area.</li><li>Aseptic processing experience and familiarity with cGMPs.</li><li>2+ years experience in pharmaceuticals/biotechnology that includes elements of new product development, process characterization, and formulation development.</li><li>Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with pertinent analytical techniques (i.e. SEC, CEX, CE, HIAC, MFI).</li><li>Understanding of physical/chemical stability of proteins and how process-related stresses impact molecule attributes and product quality.</li><li>Experience with regulatory filings and compliance issues</li><li>Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, adhere to instructions, and follow company policies.</li><li>Self-motivation, adaptability and a positive attitude.</li><li>Critical thinking, problem solving and independent research skills.</li><li>Good organizational skills with strong attention to detail.</li><li>Excellent communication (oral and written).</li></ul><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/xWr64ATmLpZ5to6NuxWoB"> <p>PI119286557</p>

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Posted: 2020-03-24 Expires: 2020-04-24

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Senior Associate

Amgen
Thousand Oaks, CA 91360

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