The responsibilities of this role include:
- Project leadership management and support for synthetics and/or process chemistry-focused (small molecule, synthetic peptides, and oligonucleotides) external projects spanning development and clinical manufacture in close coordination with internal technical leads sometimes in coordination with the Program Externalization Lead/Manager
- Opportunity to support external projects in areas beyond synthetic Drug Substance including Drug Product and Attribute Sciences and potentially biologics Drug Substance
- Work under some guidance to manage of multiple assignments and/or business processes
- Build and support positive relationships with all Process Development functions to increase overall efficiency and success of projects
- Outsourcing support and/or management including site selection activities
- Develop scopes of work in close partnership with technical leads and/or Externalization Lead/Manager
- Ensure projects and/or programs meet results, compliance, speed, quality, and cost
- Manage purchase orders, financial forecasting, and associated budget for externalization to adhere to financial targets and systems
- Coordination of requests for shipment of materials/samples between sites
- Maintain external collaborations and monitor supplier performance to continuously improve efficiency and effectiveness of suppliers
- Identify project optimization opportunities (e.g., timeline, budget, technical completion)
- Present analyses and recommendations to Senior Management
- Occasional domestic and international travel to support project results
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The strategic professional we seek is a program advisor with these qualifications.
- Doctorate degree OR
- Masters degree and 3 years of Scientific experience OR
- Bachelors degree and 5 years of Scientific experience OR
- Associate's degree and 10 years of Scientific experience OR
- High school diploma/GED and 12 years of Scientific experience
- Advanced degree in engineering or science
- Understanding of drug development and commercialization for synthetic therapeutics, including route scouting, raw material and starting material procurement, API/drug substance manufacture, process development, process engineering, and process characterization
- Experience working with domestic and international CMOs/CROs
- Understanding of cGMP, Regulatory/CMC, legal, quality requirements, and/or import/export policies
- Enthusiastic team member with a moderate-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results
- Team member of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiences
- Understanding of legal obligations to protect intellectual property
- Understanding of international import/export policies
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.