Sr Engineer - Pivotal and Commercial Synthetics
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.
Senior EngineerPivotal and Commercial SyntheticsLive
What you will do
Lets do this. Lets change the world. In this dynamic role you will own the process optimization, characterization and technical transfer of Amgens synthetic drug substance processes across all phases of development and commercialization. Responsibilities include:
- Executions of bench/kilo laboratory experimentation and process modeling/simulation to craft and optimize robust synthetic processes.
- Critically evaluate new processes for identification of process improvements and requirements vital to prepare processes for scale up and tech transfer.
- Use, refine and develop models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations.
- Analyze and detail the economic value of existing, proposed process solutions and new process concepts.
- Assess and develop continuous processing technologies to prepare processes for scale up and tech transfer.
- Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents, process fit assessments, manufacturing support, risk analysis and process documentation.
- Represent organization within a multi-functional team to ensure work aligned with tech transfer timeline are established and achieved.
- Apply standard engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.
- Routinely supervise manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting mentorship.
- Apply engineering principles and statistical analysis, including design of experiments, in-order to critically evaluate chemical processes for identification of process improvements and requirements vital for scale up and tech transfer.
- Author, review and/or approve of process documentation needed for process validation and commercialization.
- Chip in to key regulatory and quality activities such as NDAs, non-conformances, process performance qualification and continued process verification.
- Provide on the floor support to ensure successful scale up and rapid problem solving and decision making.
- Lead or represent department as authority for process risk analysis.
- Work closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide improved understanding and guidance for synthesis and unit operations.
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.Basic Qualifications:
- Doctorate Degree OR Masters degree and 3 years of Engineering or Operations experience OR Bachelors degree and 5 years of Engineering or Operations experience
- 5+ years of engineering experience driving work you're doing for pharmaceutical processes development and manufacturing
- Experience in developing and executing experimental plans to evaluate and develop processes to achieve optimum cost, robustness and productivity.
- Experience related to technology transfer, scale-up and manufacturing of synthetic molecules in regulated environment. This includes technical support for nonconformance investigations and other commercial support activities.
- Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.
- Experience building and utilizing first principle models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
- Knowledge of analytical techniques and solid-state characterization with proficiency in a wide variety of methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
- Experience using data science and/or sophisticated statistical analysis in-order to tackle processing issues and evaluate opportunities for process improvements
- Possess strong understanding of regulatory and cGMP requirements
- Command of lab and plant operations and associated safety practices
- Strong communication and presentation skills
- Fluency in German and/or Italian a plus
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.
#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.Amgen requires all staff in the United States and Puerto Rico 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.