Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and a steadfast focus on safety, quality, and compliance.
Join a highly technical and focused organization built to provide process development expertise to the transfer, support, and commercialization of sterile parenteral drug products delivering high quality products to the patients that we serve.
The Principal Engineer provides drug product process development technical support for oncolytic virus manufacturing. As a technical leader, you will deliver process development expertise for commercial DP processing in specific areas such as sterile processing, process characterization, technology transfer and validation.
- Develop process optimization strategies and solve problems for such unit operations as freezing/thawing, formulation, filtration, sterile filling, inspection, and transportation, for parenteral products.
- Support commercial DP manufacturing operations with technical assessment of change controls, deviations, corrective and preventative actions, scale up, and execute process trending and monitoring. Conduct FMEA for DP operations and propose / implement appropriate actions. Develop and characterize drug product processes.
- Support regulatory submissions.
- Responsibilities may also include leading multi-functional/site teams to support the above activities, providing recommendations for implementation.
- Provide hands on support for DP manufacturing processes and equipment.
- This includes solving problems and improving existing DP filling, inspection and labelling equipment.
- Provide product requirement specifications and design review for new DP processing equipment.
- Support the commissioning and validation of DP processing equipment.
- Limited travel to other domestic and international manufacturing sites.
Doctorate degree and 2 years of Engineering or Operations experience
Master's degree and 6 years of Engineering or Operations experience
Bachelor's degree and 8 years of Engineering or Operations experience
Associate's degree and 10 years of Engineering or Operations experience
High school diploma / GED and 12 years of Engineering or Operations experience
- 10 + years' experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
- M.S. in Life Sciences or Engineering.
- 8 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
- Multi-functional project management, extensive knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to multi-functional teams to advance sophisticated projects to completion.
- Strong skills in applying fundamental engineering and scientific principles to the design and implementation of freeze-thawing, filtration, mixing, and filling.
- Knowledge of protein biochemistry with regard to chemical and physical stability.
- Excellent written and verbal communication skills.
- Project management skills including the ability to lead multiple projects and evaluate project resource requirements.
- Strong mechanical background working within a GMP environment.
- Established Leadership capabilities
- Passion for Operational Excellence
- Financial acumen
- Communications skills, both oral and written, including executive presentation skills
- Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
- Ability to tactfully negotiate and positively influence peers and executive leadership
- Analytical skills to identify potential improvement opportunities
- Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
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 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.