26 days old

Associate, Process Development - Pivotal Drug Product

Amgen
Cambridge, MA 02138
  • Job Code
    118800279
Amgen

Job ID: R-95343
Location: Cambridge, MA, US 02139

The Pivotal Drug Product Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug product manufacturing processes for all late-stage programs across the Amgen portfolio.

Amgen is currently seeking a Process Development 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). The 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.

Responsibilities:
  • Take part in the planning and design of formulation and process development studies by applying basic science/engineering skills and prior knowledge
  • Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g. UF/DF, filtration, freeze-thaw, stability)
  • Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content)
  • Perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)
  • Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.
  • Author/review technical protocols and reports
  • Participate in team meetings by sharing study designs, results and technical challenges


Basic Qualifications:

Bachelor's degree or bachelor's degree completed by June 2020

OR

Associate degree and 4 years of Scientific, Engineering or Operations experience

Preferred Qualifications:
  • Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area
  • 1+ years of experience in pharmaceuticals/biotechnology that includes process characterization, formulation development, equipment design and implementation, technology transfers
  • Familiarity with pharmaceutical/biotechnology process development
  • Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with meaningful 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
  • Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
  • 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)
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies
  • Self-motivation, flexibility and a positive attitude
  • Critical thinking, problem solving and independent research skills
  • Good interpersonal skills with strong attention to detail
  • Excellent communication (oral and written)


We understand that to optimally sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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 demonstrates 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.

PI118800279

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95343<br/><b>Location: </b>Cambridge, MA, US 02139<br/><br/>The Pivotal Drug Product Technologies organization at Amgen develops, characterizes and supports the commercialization of the drug product manufacturing processes for all late-stage programs across the Amgen portfolio.<br><br>Amgen is currently seeking a Process Development 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). The 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.<br><br><b>Responsibilities:</b><br><ul><li>Take part in the planning and design of formulation and process development studies by applying basic science/engineering skills and prior knowledge</li><li>Participate in the execution and documentation of laboratory studies with a high degree of accuracy (e.g. UF/DF, filtration, freeze-thaw, stability)</li><li>Evaluate product and process performance through analytical testing (e.g. U/HPLC, particle analysis, moisture content)</li><li>Perform data analysis using statistical analysis software (e.g. JMP, SAS, etc.)</li><li>Apply advanced digital tools to automate data structuring, analyze large and diverse datasets and build intuitive visualizations.</li><li>Author/review technical protocols and reports</li><li>Participate in team meetings by sharing study designs, results and technical challenges</li></ul><br><br><b>Basic Qualifications:</b><br><br>Bachelor's degree or bachelor's degree completed by June 2020<br><br>OR<br><br>Associate degree and 4 years of Scientific, Engineering or Operations experience<br><br><b>Preferred Qualifications:</b><br><ul><li>Degree in Chemical Engineering, Biomedical Engineering, Biochemistry, Biotechnology, Pharmaceutics or related subject area</li><li>1+ years of experience in pharmaceuticals/biotechnology that includes process characterization, formulation development, equipment design and implementation, technology transfers</li><li>Familiarity with pharmaceutical/biotechnology process development</li><li>Knowledge of Drug Product unit operations (i.e. ultrafiltration/diafiltration, filling, filtration, mixing, etc.) and experience with meaningful 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>Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)</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>Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and align with company policies</li><li>Self-motivation, flexibility and a positive attitude</li><li>Critical thinking, problem solving and independent research skills</li><li>Good interpersonal skills with strong attention to detail</li><li>Excellent communication (oral and written)</li></ul><br><br>We understand that to optimally sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.<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 demonstrates 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/k54LNySNPlOxf7A8i4BJg"> <p>PI118800279</p>

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Posted: 2020-03-06 Expires: 2020-04-06

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Associate, Process Development - Pivotal Drug Product

Amgen
Cambridge, MA 02138

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