Process Development Sr Associate Scientist

Job Summary

Process Development Associate Scientist (compendial focusing) Key Responsibilities:

Laboratory/Office-based position where focus will be on driving cutting-edge analytical support (compendial methods focusing) and technology development impacting process and product development teams across Amgens portfolio

Work cross-functionally by partnering with quality control, manufacture, regulatory affair as well as other process development functions while using analytical science to help drive efficient development and scalable understanding of processes and products in Amgens pipeline as well as ensure the general compliance practice within Amgen

Basic Qualifications

Masters degree and 3 years of Scientific experience

OR

Bachelors degree and 5 years of Scientific experience

Preferred Qualifications

• Masters degree in Analytical Chemistry, Physical, Pharmaceutical, Life Sciences or Engineering
• Training and expertise in bio-pharmaceutical products analytical methods or formulation development
• 3+ years in the pharmaceutical or biotech industry
• Strong understanding, research in, and hands-on experience with basic bio-tech products tests, such as Solo VPE, Osmolality, pH, Turbidity et al, as applied to pharmaceutical development
• Strong experience on pharmaceutical compliance requirement, including pharmacopoeias basic structure/revision for different jurisdiction
• Strong understanding of bio-tech products process development principle as well as GMP manufacture/QC environment
• Demonstrated ability to analyze and interpret analytical data
• Excellent written and oral communication skills for the timely documentation, presentation, and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment and demonstrate leading ability to drive decision-making
• Strong technical aptitude for willing to learn and deep dive for novel technologies and continuous improvement for existing process/method applied to process development
• Strong experience on managing projects in a distant manner with key partners at different locations / communicating with different vendors/instrument manufactures for support
• Familiarity with automation and implementing data management systems; ability to compile and communicate complex datasets in a manner in which facilitates informed decision-making
• Strong abilities in troubleshooting, problem solving, and multi-tasking in support of process development and formulation efforts at the pivotal phase

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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.

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.