27 days old

Sr. Engineer (Process Development)

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    134286460
  • Jobs Rated
    8th
Amgen

Job ID: R-116918
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.

PROCESS DEVELOPMENT SR ENGINEER - PIVOTAL DRUG PRODUCT TECHNOLOGIES

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 is responsible for late stage drug product formulation and fill/finish process development for various biological modalities (e.g. monoclonal antibodies, bispecific T-cell engagers (BiTEs) and fusion proteins). The Sr. Engineer 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, the position will have focus in the application of data science and statistics to inform decisions throughout drug product development.

Responsibilities will include:

  • Lead the design and planning of laboratory studies related to formulation and fill/finish process development by applying basic science/engineering skills, first principles modeling, and prior knowledge
  • Execute and detail laboratory studies with a high degree of technical rigor
  • Develop technical project plans to generate comprehensive data packages in support of commercial formulation/process development and process characterization
  • Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
  • Manage multiple activities in parallel to drive project plans to completion, meeting project timelines and achievements
  • Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
  • 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 non-conformance investigations and process changes/improvements.
  • Provide guidance on safe and standard utilization of complex lab equipment
  • Author and review technical protocols, reports, and regulatory sections in support of INDa and marketing application submissions.
  • Contribute to progress reports and presentations to management on technical challenges, proposed solutions and results.


Win

What we expect of you

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

Basic Qualifications

Doctorate degree

OR

Master's degree & 3 years of scientific experience

OR

Bachelor's degree & 5 years of scientific experience

OR

Associates degree & 10 years of scientific experience

Or

High school diploma / GED and 12 years of scientific experience

Preferred Qualifications:

  • 5 or more years of industry experience in pharmaceuticals/biotechnology including manufacturing experience
  • Experience with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up
  • Strong problem solving and effective cross-functional communication skills
  • Demonstrated ability to operate independently
  • Experience that includes elements of new product development, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments.
  • Ability to learn and act on dynamic information at a rapid pace.
  • Strong technical writing skills as it applies to authoring technical reports and regulatory submissions
  • Strong organizational skills with attention to detail
  • Effective cross-functional communication skills
  • Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
  • Demonstrated leadership skills with the ability to build teams and operate across functional boundaries


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.





PI134286460

Jobs Rated Reports for Software Engineer

Posted: 2021-04-17 Expires: 2021-05-19

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Sr. Engineer (Process Development)

Amgen
Thousand Oaks, CA 91360

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