Process Development Downstream Bioprocess Engineer
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.
Process Development Downstream Bioprocess EngineerLive
What you will do
Lets do this. Lets change the world. In this vital role you will function as a member of a team passionate about bioprocess purification process optimization, drug substance manufacturing support and new product introductions. The site operates two multiproduct facilities that manufacture a range of innovative biologic and biosimilar medicines. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility.Responsibilities include:
- Apply a fundamental understanding of protein purification unit operations to support commercial manufacturing processes:
- large-scale column chromatography
- tangential flow filtration
- normal flow filtration
- virus inactivation and virus filtration
- Use comprehensive understanding of chemical engineering principles for the scale up of unit operations from bench to commercial scale.
- Provide technical leadership in solving clinical and commercial drug substance process issues involving equipment, scale, and raw materials. Evaluate process capabilities to develop and implement process and yield improvement opportunities.
- Partner with the Process Development laboratories to design experimentation to support process scale up. Perform technical review of data, and author and review GMP documentation.
- Implement technology transfer projects to support Amgen Network initiatives. Provide floor support during clinical and validation runs.
The Engineer will be encouraged to keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings. This role provides a great opportunity for career development in areas of leadership, teamwork, collaboration, communication and to develop network influence by partnering with colleagues in Process Development, Manufacturing, and Quality and Information Systems.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
- Masters degree OR
- Bachelors and 2 years of Process Development or Operations experience Or
- Associates degree and 6 years of Process Development or Operations experience Or
- High school diploma/GED and 8 years of Process Development or Operations experience
- 1-2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
- Possess basic understanding of regulatory and cGMP requirements
- Able to apply engineering principles and statistical analysis -- including design of experiments -- to solve processing issues and evaluate opportunities for process improvements
- Excellent written and verbal communication
- Ability to work under moderate direction.
- Able to analyze and interpret data
- Be a self-starter with the ability to tackle several projects at one time
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also 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
Join UsIf 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.
We will ensure that individuals with disabilities are provided 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 accommodation.Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.