External Process Development, Manager

Thousand Oaks, CA, US
Oct 06, 2020
Required Education
High School or equivalent
Position Type
Full time
Job Summary

Amgen is seeking a Manager to join the External Process Development Organization, at either the Thousand Oaks, CA campus or Cambridge, MA office.

The External Process Development (XPD) Manager will work with CRO's/CMO's to deliver on Amgen's pipeline molecules. The XPD group develops the external sourcing strategy for Amgen's process development (PD) organization and drives implementation of the strategy across the development portfolio.

XPD is part of the Business Analysis External Process Development organization (BAX) which is responsible for business analysis, development sourcing strategy/implementation, resource and budget planning, and performance management for Amgen's PD organization.

Job Responsibilities include:
  • Technical project leadership for a portfolio of cross-disciplinary external projects traversing the areas of Drug Product, Drug Substance, and Attribute Sciences. Primary focus will be to lead delivery of large molecule analytical work packages (method qualification, method transfer, release testing, stability testing, characterization) with external contract development and manufacturing organizations.
  • Ensuring programs meet compliance, speed, quality, and cost targets through strong scientific and technical understanding of the programs and drug product development.
  • Being a self-starter who can orchestrate multiple assignments.
  • Identification of project optimization opportunities (timeline, budget, technical implementation), prioritization of a rolling portfolio of projects
  • Building and maintaining positive relationships with all Process Development functions to increase overall efficiency and effectiveness, and success of programs.
  • Ability to lead highly matrixed teams.
  • Spearheading supplier evaluation and selection
  • Supplier relationship management, including development and reporting of metrics and monitoring 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
  • This position will require occasional global travel

Basic Qualifications:
  • Doctorate Degree
  • Master's Degree & 3 years of Scientific experience
  • Bachelor's Degree & 5 years of Scientific experience
  • Associates degree & 10 years of Scientific experience
  • High school diploma/GED & 12 years of Scientific experience

Preferred Qualifications:
  • Advanced degree in engineering or the sciences.
  • Experience in large molecule analytical development including method development, method qualifications/transfers/validations, release, stability and characterization testing.
  • Self-starter with a high-level of comfort with ambiguity and complexity and the ability to successfully multi-task while consistently delivering quality results
  • Experience collaborating with domestic and international CMO/CRO organizations
  • Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
  • Demonstrated and proficient 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
  • Keen business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and resolve complex problems
  • Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management

Amgen is committed and dedicated 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.

Come join us!

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.

Join Us

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.