11 days old

Process Development Scientist -Bioprocess Development

Amgen
Thousand Oaks, CA 91360
  • Job Code
    126097051
Amgen

Job ID: R-107946
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 Scientist - Bioprocess Development

This organization develops, characterizes and supports the production of the drug substance manufacturing processes for all early-stage programs across the Amgen portfolio, enabling advancement of programs from pre-clinical through Ph I/II clinical trials.

Live

What you will do

Let's do this. Let's change the world. In this vital role you will lead laboratory-focused projects, collaborating with cell culture and purification scientists who develop robust clinical processes to advance Amgen's biologics pipeline.

The scope of work and responsibility include but not limited to protein construct selection, clinical process development, support of technology transfer, authoring regulatory CMC documents, and interacting with regulatory agencies. In addition, you will lead and support efforts to develop and implement new technologies and new business strategies to drive organizational efficiency.
  • Independently authors technical reports, regulatory filings, patents, peer reviewed publications and actively participates in scientific conferences
  • Convey information and makes recommendations on scientific issues to senior management
  • Develop technology to deliver multi-kilogram quantities of drug substance in a safe, practical and efficient manner
  • Provide significant contributions to drug substance development teams (e.g., product, process development and product quality teams) by providing drug substance updates, documentation, data interpretation, technical recommendations, etc.
  • Serve as a technical authority and keeps current in relevant literature and related technology with a record of successful application of said technology complying to current and emerging regulatory requirements (FDA, EMA, ICH, etc)
  • Work cross-functionally to author CMC regulatory documents and documentation in support of Amgen's regulatory filings
  • Develop processes amenable to cGMP operation and leads deliveries of drug substance in a cGMP Manufacturing environment in both internal and external capacity for batch and continuous processes
  • Ensures that safe laboratory practices are followed
  • Provides mentoring and expertise to less-experienced staff


Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master's degree and 4 years of experience contributing to and/or participating in scientific project teams

OR

Bachelor's degree and 6 years of experience contributing to and/or participating in scientific project teams

Preferred Qualifications:

  • Doctorate in a biological science field or chemical engineering with 2 plus years of experience
  • Expertise and experience in mammalian cell culture and/or purification process development
  • Extensive experience in development and/or support of bio-manufacturing processes, including process scale-up and GMP production
  • Experience in CMC clinical and commercialization process
  • Track record of innovation and implementation of new technologies
  • Experience in authoring IND sections and interaction with regulatory agencies


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

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.



PI126097051
Posted: 2020-11-17 Expires: 2020-12-18

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Process Development Scientist -Bioprocess Development

Amgen
Thousand Oaks, CA 91360

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