HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
What you will do
Lets do this. Lets change the world. In this dynamic role you will provide technical and project support while integrating information generated by multi-functional teams to ensure success through the commercialization and life-cycle of the products. Responsibilities include:
- Support Drug Product Commercialization Teams responsible for planning, designing, implementing, and documenting laboratory studies related to drug product design, formulation, and process development in support of commercialization and lifecycle management of both parenteral and oral solid dosage presentations management of parenteral products.
- 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.
- Drive continuous improvement in the drug product development process through technological innovation and application of first principles in process engineering.
- Participate on global multi-functional teams working effectively in a highly matrixed team environment to influence and inspire change, efficiency, and cultivate strong relationships.
- Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions.
- Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
- Actively use advanced IS systems to improve drug product design through faster data availability, using historical information, analyzing large data sets, and statistical analysis.
- Ability to travel domestically and internationally up to 10% of the time.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.
- Doctorate degree OR Masters degree and 3 years of Engineering experience OR Bachelors degree and 5 years of Engineering experience OR Associates degree and 10 years of Engineering experience OR High School diploma/GED and 12 years of Engineering experience.
- Advanced degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
- 5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
- Knowledge of/hands-on experience with end-to-end development for liquid and lyophilized drug products in various presentations
- Knowledge and awareness of the regulations governing combination product development
- Experience with unit operation for parenteral manufacturing (i.e. filling, filtration, mixing, etc.), specific scale-down model development, characterization, and scale-up
- Understanding of physical/chemical stability of proteins and how process related stress impacts product quality, specifically, the impact of freezing and drying to short- and long-term stability
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com