Amgen

Manager External Process Development

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jun 25, 2019
Ref
R-73827
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. The 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. External Process Development is part of the Business Analysis External Process Development organization (BAX) which is responsible for business analysis, development sourcing strategy and execution, resource and budget planning, and performance management for Amgen's PD organization.

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

Job Responsibilities include:
  • 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
  • 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
  • This position will require occasional domestic and international travel


Preferred Qualifications

Advanced degree in chemical, biological, or bio-molecular engineering, biochemistry or molecular biology.

Experience in Biologics process development (cell culture and/or purification).

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 matrixed 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