Process Development Scientist

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Process Development Scientist: Drug Product Technologies (Synthetics)

What you will do

Lets do this. Lets change the world. In this vital role you will be part of our Pivotal Synthetics Drug Product Technologies in the Thousand Oaks, CA headquarters. This group is responsible for late stage synthetics drug product formulation and process development, focusing on, but not limited to solid dosage form development. The Scientist will provide technical and project leadership, integrating effective cross functional collaboration, to ensure success through the Drug Product commercialization process and lifecycle management. Platform capabilities, prior product knowledge, modeling, and data analytics/visualization will be applied to advance Amgens pipeline.

The responsibilities of this candidate will include:

• Participate in cross-functional Synthetics Drug Product Commercialization Teams responsible for conducting tablet/capsule/parenteral formulation and process development/characterization of pipeline products and for supporting commercial products through lifecycle management
• Design, plan, execute, and document formulation and process development studies
• Apply scientific/engineering principles and techniques to develop, characterize and implement processes and next generation technologies and to tackle technical challenges
• Apply sophisticated statistical/data analytics techniques to draw conclusions and inform decisions
• Participate in GMP manufacturing of clinical trial materials to support clinical studies as needed.
• Provide support to manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for process changes/improvements and non-conformance investigations
• Author/review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
• Stay current on the latest developments in the industry and scientific community to continue innovating and to meet future business needs
• Optimally and consistently connect with management, cross-functional partners and relevant stakeholders on progress towards breakthroughs and forthcoming program needs.

Win

What we expect of you

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

Basic Qualifications:

Doctorate degree

OR

Masters degree and 4 years of scientific experience

OR

Bachelors degree and 6 years of scientific experience

Preferred Qualifications:

• Advanced degree in Pharmaceutics, Chemistry, Chemical Engineering, Mechanical Engineering, Materials Science, Biotechnology or related subject area
• Experience in small molecule pharmaceutical development and manufacturing
• Experience in small molecule formulation and process development, process characterization, technical transfers to manufacturing sites, and statistical design and analysis of experiments (DOE), and regulatory authoring.
• Experience in typical unit operations for the manufacture of oral solid dosage forms (i.e. granulation, drying, milling, blending, compression, etc.), and the associated GMP documentation and regulatory filings.
• Experience with unique technologies (e.g., spray drying, hot melt extrusion, Wurster coating, etc.).
• 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)
• Proficiency in at least one statistical software package (e.g. SAS, JMP or Minitab)
• Critical thinking, problem solving and independent research skills
• Strong project management skills, including the ability to manage ones project resources (material, manpower, time, etc.)
• Good organizational skills with strong attention to detail
• Strong ability to operate well in a fast-paced, matrixed environment and collaborate optimally cross-functionally

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.