Process Development Manager - External Process Development (XPD)
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.
Process Development Manager - External Process Development (XPD)Live
What you will do
Lets do this. Lets change the world. In this vital role you will join the Synthetic Drug Substance External Process Development (XPD) outsourcing team. This group was built to develop Process Developments sourcing strategy and drive the implementation of this strategy across the development portfolio.
You will work with CRO/CMOs to support development, clinical manufacture, and business management. Lead the implementation of sourcing initiatives and manage a variety of external projects engaging domestic, international, and emerging market suppliers.
Project leadership 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
Opportunity to lead external projects in areas beyond synthetic Drug Substance including Drug Product and Attribute Sciences and potentially biologics Drug Substance
Work under minimal guidance to manage of multiple assignments and/or business processes
Build and maintain positive relationships with all Process Development functions to increase overall efficiency and success of programs
Supplier evaluation and outsourcing management including site selection activities
Develop scopes of work in close partnership with technical and functional leads
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
Establish and maintain relationships with 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 process development professional we seek is a self-starter with these qualifications.
Masters degree and 4 years of life sciences industry experience
Bachelors degree and 6 years of life sciences industry experience
Associate's degree and 10 years of life sciences industry experience
High school diploma/GED and 12 years of life sciences industry experiencePreferred Qualifications:
Advanced degree in chemistry, biochemistry, or chemical engineering is preferred
Demonstrated 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 import/export policies
Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results
Experienced team member of cross-functional and matrixed teams including effective writing, presentation, and interpersonal skills to address a broad scope of audiences
An eye for business, high-level critical thinking, and strong problem-solving skills with the ability to structure, pragmatically scope, and solve 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.