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Executive Director, Process Development

Amgen

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Location:
United States, Juncos

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Category:
-

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Contract Type:
Not provided

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Salary:

268622.00 - 321865.00 USD / Year
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Job Description:

In this vital role, you are responsible for scientific and technical leadership of Drug Substance (DS) manufacturing processes and Attribute Sciences functions at Amgen’s Puerto Rico site. Oversight responsibilities span commercialization through full scale process validation and life-cycle management of processes and methods for Amgen’s mammalian and microbial DS manufacturing facilities in Puerto Rico. This executive leader will work in close collaboration with Manufacturing, Engineering, Finance, Supply Chain and Quality functions to enable progressive improvements in commercial processes and analytical methods. You will have direct strategic responsibility for leading a team of 80+ scientists/engineers to support a growing portfolio with increased volumes.

Job Responsibility:

  • Drug substance technology and analytical method transfer to and from the site
  • Process validation at scale across the two DS manufacturing plants
  • Drug substance and Attribute science CMC authoring activities for products, the latter in partnership with Attribute Sciences
  • Process monitoring activities, including real time multi-variate statistical process monitoring
  • Life cycle improvements in commercial process, including improvements to increase yields and reduce cost of goods manufactured
  • Ensure manufacturing operations are aligned with the registered process
  • Provide oversight and support for technical investigations
  • Safety and compliance of process development activities
  • Developing strategy, setting goals and priorities, allocating resources, monitoring project progress, and managing the organization’s budget

Requirements:

  • Doctorate degree and 6 years of Scientific, Process Development and/or Technical Service experience
  • Master’s degree and 10 years of Scientific, Process Development and/or Technical Service experience
  • Bachelor's degree and 12 years of Scientific, Process Development and/or Technical Service experience
  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Nice to have:

  • PhD with 15+ years technical experience or a MS with 20+ years of technical experience in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline and 10+ years of managerial experience in a cGMP environment
  • Practical knowledge of the technologies related to analytical technologies, mammalian and microbial cell culture, protein purification, automation, validation and process engineering
  • Strong technical communication skills, both written and verbal, to interact effectively with all stakeholders
  • Experience in authoring marketing authorization applications
  • Well-recognized in the scientific community through a record of peer-reviewed publications and/or patents
  • Demonstrated success developing staff, including effective feedback and coaching
  • Demonstrated collaborative experience and ability to effectively work through others
  • Business acumen with track record of innovation and continuous improvement that provided strong financial benefits
What we offer:
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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