Process Development Associate Director

Role Summary

Process Development Associate Director. Located at the Cambridge, MA site. Responsible for development, characterization, scale-up and support of upstream and downstream drug substance processes to enable commercial advancement of programs. Leads integrated group of cell culture and purification scientists and contributes to commercialization data packages and regulatory interactions.

Responsibilities

• Lead a group to apply platform approaches and rapidly solve development challenges to build robust processes with efficient experimentation.
• Develop and recruit strong and 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 coordinating with contract development and manufacturing organizations.
• Ideation, development, and deployment of differentiating technologies and fostering a culture of innovation.
• Represent Amgen in external scientific communities to expand external eminence.

Qualifications

• Basic Qualifications:
  • Bachelor‚Äôs degree and 9 years of scientific experience, or
  • Master‚Äôs degree and 7 years of scientific experience, or
  • Doctorate degree (PhD/PharmD/MD) and 4 years of scientific experience
• Preferred Qualifications:
  • Doctorate in Chemical Engineering, Biochemical Engineering, or related sciences with 4+ years of experience; Bachelor‚Äôs or Master‚Äôs with 10+ years also considered.
  • Proven problem-solving and troubleshooting in a process development environment; ability to identify, develop and implement scientific solutions.
  • Experience with drug substance commercialization activities, regulatory interactions, DOE design of experiments and statistical data analysis.
  • Strong bioprocess development expertise including cell culture, harvest, and purification.
  • Track record of innovation and scientific eminence through publications and presentations.
  • Strong interpersonal, organizational, verbal, and scientific writing skills.
  • Leadership experience with ability to inspire and lead scientists to deliver on objectives in timelines.
  • Ability to work with diverse teams in a dynamic, cross-functional environment.
  • Proven mentoring ability to help staff reach potential.

Skills

• Bioprocess development
• Cell culture, harvest, purification
• Regulatory interactions and CMC documentation
• Experiment design and statistical analysis
• Leadership and cross-functional collaboration
• Innovation and problem-solving

Education

• As specified in Basic/Preferred Qualifications above.

Additional Requirements

• Sponsorship not guaranteed.
• Physical demands not listed as essential; no explicit travel requirements stated.