Process Development Bioprocess Senior Engineer
Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients lives? Would you like to be part of an organization that is embarking on transforming manufacturing using data analytics?
We have a position available for a Senior Engineer to join our Process engineering team at our Rhode Island Site. The Sr. Engineer will be part of a team focused on bioprocess 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. Ideal candidates should possess either upstream (cell culture) or downstream (purification, chromatography) expertise.Responsibilities include:
- Apply a fundamental understanding of mammalian cell culture operations to support technology transfer and commercial manufacturing processes:
- Scale up of cell culture
- Single Use Bioreactors
- Perfusion and Harvest technologies
- Or experience in Purification operations, specifically:
- Large Scale 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.
- Execute technology transfer projects to support Amgen Network initiatives. Provide floor support during clinical and validation runs.
The Sr. 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 significant career development in areas of leadership, teamwork, collaboration, communication and to develop network influence by partnering with colleagues in Process Development, Manufacturing, as well as Quality and Information Systems.
Masters degree and 3 years of Engineering or Operations experience
Bachelors degree and 5 years of Engineering or Operations experience
Associates degree and 10 years of Engineering or Operations experience
High School diploma/GED and 12 years of Engineering or Operations experience
- 6+ years of experience in drug substance process development, characterization and/or commercial process support
- Possess advanced understanding of regulatory and cGMP requirements
- Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
- Able to manage project resources and elevate relevant issues to project lead and line management
- Excellent written and verbal communication
- Able to build and maintain high-performing, multi-functional partnerships and to lead matrix teams to advance complex projects to completion
- Demonstrated ability to work under minimal direction
- Be able to multi-task and function in a dynamic environment
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.About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new sciences promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve peoples lives.
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.