Amgen

Manager External Process Development

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Nov 12, 2020
Ref
R-105890
Required Education
High School or equivalent
Position Type
Full time
Amgen is seeking a Manager to join the External Process Development Organization, the location can be at either Thousand Oaks, CA or Cambridge, MA office. Our External Process Development Manager will work with CRO's/CMO's to deliver on Amgen's pipeline molecules. The External Process Development group (XPD) develops the external sourcing strategy for Amgen's process development (PD) organization and drives implementation of the strategy across the development portfolio.

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 manage delivery of synthetic drug product development projects, including formulation, enabling technologies, process development, clinical manufacturing and packaging with external contract development and manufacturing organizations.
  • Ensuring programs meet compliance, speed, quality, and cost targets
  • Self-starter who can manage multiple assignments.
  • Identification of project optimization opportunities (timeline, budget, technical execution), prioritization of a rolling portfolio of projects
  • Building and maintaining strong partnerships with all Process Development functions to increase overall effectiveness and success of programs.
  • 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
  • Ability to travel approximately 10% domestic and internationally

Basic 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

Preferred Qualifications
  • Experience in synthetic drug product development, including tablets, capsules, oral solutions and/or enabling technologies, including manufacturing and associated analytical testing is highly desirable. Familiarity with manufacturing process equipment is also desirable.
  • Self-starter with a high-level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results
  • Experience interfacing with domestic and international CMO/CRO organizations
  • Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements and import/export policies
  • Demonstrated understanding of drug development and commercialization for synthetic and/or biologic therapeutics
  • Experience as team member/leader of cross-functional and matrix teams including effective writing, presentation, organizational and interpersonal skills to address a broad scope of audiences
  • Proven business acumen, high level strategic thinking, and strong analytical skills with the ability to structure, pragmatically scope, and solve complex problems
  • Demonstrated quantitative skills including experience in business process development, continuous improvement, operational excellence and performance management


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 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.

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.

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.