HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Sr Engineer - Drug Product Pilot PlantLive
What you will do
Lets do this. Lets change the world. In this role you will provide technical leadership to Amgens parenteral drug product process design and commercialization. The candidate will lead off-line process characterization activities and work with global technology transfer team to transfer the process to clinical/ commercial fill finish lines with the aim of reducing or eliminating the onsite characterization work required. The candidate will also play a meaningful role in developing business cases for using the pilot plant capabilities further to serve the network, support development of in silico models to enable rapid, robust, process development. Responsibilities include:
- Operate and trouble shoot filling equipment for characterization, special studies, and/or material generation to support the Amgen network
- Design, implement and document technical data packages related to drug product process design, development and characterization
- Meticulous review of protocols, and study design, to streamline execution and ensure successful implementation
- Support development of models and other data analytics tools for rapid process development and tech transfer
- Drive innovations in drug product process characterization and reduce pilot plant and clinical/ commercial GMP line time required for successful technology transfers and NPIs
- Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues, improve and develop new processes and evaluate effects of equipment changes, scale, and implementation of new raw materials
- Serve as an authority on manufacturing technologies (e.g. filling, automated visual inspection) and work with global multi-functional teams to develop and improve shared standard methodologies and technical advancements across Amgen clinical and commercial fill-finish plants
- Apply strong written and verbal communicational skills. Author technical protocols, reports and present findings and project status
- Contribute to and maintain a strong culture of safety and compliance in the plant
- Travel domestically and internationally may be required
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
- Master's degree and 3 years of Engineering experience OR
- Bachelor's degree and 5 years of Engineering experience OR
- Associate's degree and 10 years of Engineering experience OR
- High School Diploma/GED and 12 years of Engineering experience.
- Advanced degree in engineering, biotechnology, life sciences or related subject area
- 2+ years experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites
- Advanced knowledge of biopharmaceutical manufacturing and business processes, and experience supporting GMP manufacturing operations
- Knowledge of, and hands-on experience with various drug product technologies related to fill-finish process (freeze-thaw, filtration, filling, isolators, visual inspection operations etc.)
- Ability to lead innovation, collaborate in a multi-functional team, and act on dynamic information at a rapid pace
- Ability to independently design and complete characterization studies, author characterization protocols, process transfer documents, and technical reports
- Proficiency in technical problem solving, critical thinking, and the delivery of technical solutions with limited oversight
- Capable of organizing and communicating technical concepts to enable business decisions
- Demonstrated skills in leading diverse multi-functional projects
What you can expect of us
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.
The annual base salary range for this opportunity in the U.S. is $111,913.00 to $132,048.00.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.careers.amgen.com
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 cancers, 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.