Process Development Associate Director

Role Summary

Process Development Associate Director. Lead a group of cell culture and purification scientists to advance upstream and downstream drug substance processes for commercial advancement, located in Cambridge, MA.

Responsibilities

• Lead a group to apply platform approaches and solve development challenges, building robust processes with efficient experimentation across biologics modalities.
• Develop and recruit strong, diverse teams and support staff in their career development.
• Lead matrix cross-functional teams delivering robust drug substance commercialization data packages, including authoring CMC sections of regulatory documents, interacting with regulatory agencies, supporting technology transfers, and working with contract development and manufacturing organizations.
• Ideate, develop, and deploy differentiating technologies and foster a culture of innovation.
• Represent Amgen in the external scientific community and expand external eminence.

Qualifications

• Basic Qualifications:
  • Bachelor’s degree and 9 years of scientific experience OR
  • Master’s degree and 7 years of scientific experience OR
  • Doctorate degree (PhD, PharmD, or MD) with 4 years of scientific experience
• Preferred Qualifications:
  • Doctorate in Chemical Engineering, Biochemical Engineering, or related sciences with 4+ years of experience; Bachelor’s or Master’s with 10+ years considered.
  • Proven problem-solving in a process development environment and ability to independently identify and implement scientific solutions.
  • Experience with drug substance commercialization activities, regulatory interactions, design of experiments, and statistical analysis.
  • Strong bioprocess development expertise including cell culture, harvest, and purification.
  • Innovative track record with peer-reviewed publications and conference presentations.
  • Excellent interpersonal, organizational, verbal, and scientific writing skills; leadership experience and ability to inspire a group of scientists; collaboration across diverse teams.
  • Proven mentoring ability to help staff reach their potential.

Skills

• Bioprocess development (cell culture, harvest, purification)
• Leadership and people development
• Regulatory interactions and CMC documentation
• Experiment design and statistical data analysis
• Cross-functional collaboration
• Scientific communication and writing

Education

• Doctorate preferred (PhD, PharmD, or MD) in Chemical Engineering, Biochemical Engineering, or related field; other degrees with equivalent experience considered.

Additional Requirements

• Travel none specified as essential in description.