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.Live
What you will do
Lets do this! Lets change the world!
Amgen is seeking a Senior (Sr.) Engineer to join the Drug Substance Process Engineering team responsible for supporting Amgen Drug Substance Manufacturing facilities.
The Sr. Engineer will play a key role in process engineering, process validation and technology transfer support for human therapeutic products (biological drug substance) across the clinical and commercial manufacturing space.
The position can be at either the Amgen Thousand Oaks (CA) or Amgen Cambridge (MA) locations.Responsibilities for the Senior Engineer will include the following:
- Transfer processes and process improvements from the laboratory into cGMP manufacturing facilities and between manufacturing sites
- Provide on-the-floor and remote technical support to ensure the success of production runs
- Perform process modeling/simulation and introduce new process technology for clinical and commercial production; perform process monitoring, data trending and advanced statistical process analysis activities; assess product impact, and provide technical troubleshooting using sophisticated digital tools
- Provide technical support for process related deviations (NCs), CAPAs and change controls
- Develop Process Validation strategies to support the commercialization of late-phase clinical programs and modifications to commercial processes
- Present on process performance to management and technical forums
- Identify and advance operational excellence opportunities to continually improve efficiency
- Technical project management
- Support of regulatory filings and inspections
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.Basic Qualifications:
Masters degree and 3 years of experience in Engineering or Operations
Bachelors degree and 5 years of experience in Engineering or Operations
Associates degree and 10 years of experience in Engineering or Operations
High school diploma / GED and 12 years of experience in Engineering or OperationsPreferred Qualifications:
- MS in Chemical/Biochemical Engineer or other biological engineering field and 5+ years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP)
- Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance.
- In-depth understanding of chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations
- Solid understanding of cell culture process scale up, mass oxygen transfer, metabolism profiling, process deviation impact to growth and quality attributes, harvest/clarification processes, raw material including media component impact to cell culture. Good knowledge of aseptic processing/techniques.
- Process validation, process characterization and process monitoring experience
- Experience in supporting regulatory inspections
- Process development experience supporting and transferring technology for cGMP manufacturing at large scale
- Good written and verbal communication skills
- Experience in preparing regulatory filings and participation in regulatory inspections
- Process development and optimization experience with late stage or commercial products
- Process equipment design and evaluation expertise
- Experience with risk analysis methodologies
- Independently motivated with ability to multi-task and work in teams
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
Objects in your future are closer than they appear. Join us.
#Operations21Equal 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 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.