Process Development Senior Scientist (Drug Product)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. 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. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Process Development Senior Scientist (Drug Product)

Live

What you will do

Let's do this. Let's change the world. In this vital role you will be part of our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage biologics drug product formulation and fill/finish process development. The Senior Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.

Responsibilities include:

• Lead cross-functional Drug Product Commercialization Teams responsible for formulation development, fill/finish process development/characterization, technology transfer, and regulatory authoring for pipeline and lifecycle management projects.
• Coordinate and participate in the planning, design, execution, and documentation of formulation and fill/finish process development studies.
• Lead a team of engineers and scientists to advance program and functional objectives
• Expand the utilization of sophisticated IS systems to improve drug product design through faster data availability, utilizing historical information, analyzing large data sets, and statistical analysis.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
• Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
• Serve as subject matter authority in drug product technologies and help drive best practices and technical advancements
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
• Participate and lead global cross-functional teams working optimally in a highly matrixed team environment to drive change, efficiency, and positive relationships
• 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 biotech scientific professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications

Doctorate degree & 2 years of scientific experience

OR

Master's degree & 6 years of scientific experience

OR

Bachelor's degree & 8years of scientific experience
Or

Associate's degree and 10 years of scientific experience
Or

High school diploma / GED and 12 years of scientific experience

Preferred Qualifications

• Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related discipline
• 5 or more years of demonstrated ability that includes elements of formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments, and regulatory authoring.
• Leadership of highly technical specialists with demonstrated results driving forward pipeline and lifecycle management programs
• Knowledge of, and hands-on experience with, bringing new biotech products to market, across various dosage forms and device delivery systems.
• Experience with sophisticated drug delivery for biologics including sustained release, nasal, pulmonary, or dermal delivery
• Experience participating and leading global cross-functional teams
• Outstanding knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling, and the associated GMP/Device documentation and regulatory filings.
• Strong problem solving and effective cross-functional communication skills.
• Ability to learn and act on dynamic information at a rapid pace.

Thrive

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization
• 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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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.