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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Reporting to the Director of Process Development, this role will be based in Amgens Cambridge- Massachusetts, or alternatively in Amgens, Thousand Oaks-California offices. The successful candidate will lead a team of 3-5 subject matter experts (SMEs) supporting the technology transfer and production of Amgens biologic drug products at external manufacturers. The team supports new product introductions, lifecycle changes, ongoing commercial production and development programs. US or international travel may be required to support Amgens drug product network.
- Provide technical and management leadership to a cross functional team of engineers and scientists.
- Act as a drug product technical expert, to provide leadership and solutions when troubleshooting biologic drug product manufacturing, for all processing stages such as component preparation, filling, freeze drying, visual inspection etc.
- Act as the accountable point of contact from the process development organization for product/process support for technology transfers and ongoing clinical and commercial drug product manufacturing at assigned contract manufacturing sites.
- Build excellent business relationships with contract manufacturing partners, Global Operations, External Supply Quality, and drug product process teams.
- Lead functional and cross functional teams by setting the agenda, identifying issues and driving to goal completions and target dates.
- Troubleshoot issues with drug product processing technologies and equipment.
- Escalate issues, recommendations, and/or unresolved decisions in a professional and timely manner to the appropriate governance.
- Holds others responsible or answerable for their actions, for exemplary job performance, and achieving business results.
- Visit manufacturing sites to support key production milestones and build relationships
Doctorate degree and 2 years of Engineering or Operations experience
Masters degree and 6 years of Engineering or Operations experience
Bachelors degree and 8 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
- 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.
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.