Manager External Process Development
What you will do
Lets do this. Lets change the world. In this exciting role you will work with CROs/CMOs to deliver on Amgens pipeline molecules. The External Process Development group (XPD) develops the external sourcing strategy for Amgens process development (PD) organization and drives implementation of the strategy across the development portfolio.
- Technical project leadership for a portfolio of cross-disciplinary external projects traversing the areas of Drug Substance, Drug Product, and Attribute Sciences. With an initial focus on the Biologics pipeline, there will be opportunities to also support synthetic and other modalities.
- Ensure programs meet compliance, speed, quality, and cost targets
- Identification of project optimization opportunities (timeline, budget, technical application), prioritization of a rolling portfolio of projects
- Building and maintaining positive relationships with all Process Development functions to increase overall efficiency and success of programs
- Supplier relationship management, including development and reporting of metrics and supervising performance to continuously improve efficiency and effectiveness of suppliers
- Creation of holistic business cases considering strategic, financial, and risk tradeoffs
- Presentation of analyses and recommendations to Senior Management
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a self-starter with these qualifications.
- Doctorate Degree OR Master's Degree & 3 years of Scientific experience OR Bachelor's Degree & 5 years of Scientific experience OR Associate's degree & 10 years of Scientific experience OR High school diploma/GED & 12 years of Scientific experience
- Advanced degree in chemical, biological, or bio-molecular engineering, biochemistry or molecular biology is preferred.
- Experience in Biologics process development (cell culture and/or purification).
- Experience collaborating with domestic and international CMO/CRO organizations
- Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
- Solid understanding of drug development and commercialization for synthetic and/or biologic therapeutics
- Experience as team member/leader of cross-functional and matrixed teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences
- Demonstrated discernment, high level critical thinking, and strong analytical skills with the ability to structure, pragmatically scope, and tackle sophisticated problems
- Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management
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.