25 days old

Senior Associate, Process Development - Pivotal Drug Product

Amgen
Thousand Oaks, CA 91360
  • Job Code
    133778667
Amgen

Job ID: R-116128
Location: Thousand Oaks, CA, US

HOW MIGHT YOU DEFY IMAGINATION?

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Associate, Process Development - Pivotal Drug Product

Live

What you will do

Let's do this. Let's change the world. In this vital role you will join our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group leads our 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 Sr. 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.

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.

Responsibilities include:

  • Participate 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)
  • Build a wide range of data and analytics solutions, from available commercial dashboarding tools such as TIBCO Spotfire, MS Smartsheet
  • 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


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

Master's degree

Or

Bachelor's degree and 2 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 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
  • 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, and align with 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)


Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor


Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.





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Posted: 2021-04-10 Expires: 2021-05-11

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Senior Associate, Process Development - Pivotal Drug Product

Amgen
Thousand Oaks, CA 91360

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