Career Category

Job Description

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 Associate - Pivotal

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will work in 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 (large molecule, RNA, virus).

Additionally, the position works on ways to improve how data is analyzed and the use of statistical models to inform decisions throughout drug product development. The Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.

Responsibilities will include:

• Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management
• Work independently, taking ownership of projects and self-managing work packages with appropriate communication and partner concern.
• Plan, design, execute and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management.
• Apply basic science/engineering skills and first principle modeling to solve technical problems
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management
• 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
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs
• Ability to travel domestically and internationally up to 10% of the time

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The process development biotech/pharma 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 experience

Preferred Qualifications:

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related subject area or Statistics degree with experience in pharmaceutical development and manufacturing
• 2+ years of post-doctoral or experience in pharmaceuticals/biotechnology industry or related field
• 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 abilities
• Experience with coding/scripting for automated data analysis and modeling
• Experience with data visualization tools or packages, such as Tableau or Spotfire
• Experience that includes elements of new product development, formulation 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

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.