VP Manufacturing Site Leader, Thousand Oaks

Thousand Oaks, CA, US
Sep 06, 2019
Required Education
Bachelors Degree
Position Type
Full time
The Vice President of Manufacturing Site Leader is responsible for providing leadership and strategic direction for the Amgen, Thousand Oaks, Manufacturing organization. Responsibilities include leading two biologics manufacturing plants ensuring reliable supply of Amgen's products to patients across the globe. The VP Manufacturing Site Leader is a member of the global Manufacturing Leadership Team and the Process Development Leadership Team and leads an organization of >600 staff. This position is in Thousand oaks, CA, and reports to the Senior Vice President, Process Development.

Key Responsibilities:
  • Senior executive accountable for operations, quality, supply, and safety of staff across manufacturing in Thousand Oaks, CA
  • Provides that clinical and licensed products are produced according to current Good Manufacturing Practices (cGMP) and other applicable regulations
  • Maintains that manufacturing facilities, equipment, policies, processes, and procedures are compliant with cGMP requirements and/or other applicable regulations
  • Plans, directs, and leads manufacturing operations and manufacturing support functions
  • Leads clinical supply chain to plan for all clinical trial materials
  • Pilot Plant management for data and team supply delivery
  • Ensures that there is an adequate number of personnel who possess the necessary combination of education, experience and training in accordance with cGMP requirements to supervise the manufacture of Amgen products and perform assigned manufacturing functions
  • Assures that written procedures describing the manufacturing process are applicable, developed, approved, implemented, controlled and followed
  • Manages that non-conformances are reported promptly to the Quality unit and ensures that proper procedures, corrective and preventive actions are in place
  • Responsible for risks being identified, assessed and corrected
  • Alerts senior management of significant quality, compliance, supply and safety risks
  • Responsible for planning, developing, and maintaining the Thousand Oaks manufacturing department budget
  • Accountable for meeting production demands across multiple plants
  • Assesses site manufacturing capacity against the long-range plan for products or potential products manufactured in the plant
  • Establishes medium and long-term strategies to meet operational goals and objectives
  • Directs, implements and supports Continual Improvement initiatives, programs and projects
  • Serves as key liaison to high profile external organizations/associations
  • Ensures that all plants, including the facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations and specifications
  • Upholds that product quality standards are met and in compliance with applicable regulatory requirements and specifications
  • Coaches and works with staff to establish career development plans and partners with HR to recruit, develop, retain and motivate staff
  • Leads broad team structure and strategy capable of adapting to changing business needs while championing Amgen values
  • Supports the implementation of strategic initiatives and advances innovative ways to manufacture biologics
  • Sponsor or lead network wide initiatives that progress achievement of manufacturing objectives that are aligned with the Global Operations Strategy

Basic Qualifications:
  • Doctorate degree & 8 years of Manufacturing and Operations experience OR
  • Master's degree & 10 years of Manufacturing and Operations experience OR
  • Bachelor's degree & 12 years of Manufacturing and Operations experience AND
  • 8 years of direct managerial experience. Previous experience leading other managers

Preferred Qualifications:
  • 18+ years pharmaceutical/biotech industry experience in biologics manufacturing across various functions to include quality, process development, operations and/or engineering
  • Experience leading a global capability within a large biopharmaceutical company
  • Strategically focused, and inter-personally savvy demonstrating executive presence with an effort towards building effective relationships across functions
  • Broad understanding of industry trends and cutting-edge methodologies in these areas
  • Presentation skills and experience leading large, global initiatives
  • Knowledge of cGMP's and CFR's EC GMPs
  • Verbal and written communication skills
  • Analytical/critical thinking skills utilizing global perspective
  • Experience influencing and interacting successfully with senior management within and outside of Operations
  • Team development and leadership skills
  • Available and interested in mobility with Amgen globally

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.