Distinguished Scientist, Vaccines & Advanced Biotechnologies Process R&D

The Opportunity

Serve as the scientific architect for vaccine drug substance process development and clinical manufacturing; establish and drive forward-looking scientific strategy.

• Develop and execute a long-term scientific vision and technology roadmap for vaccine drug substance development and manufacturing.
• Anticipate emerging trends and integrate approaches to enhance process performance, speed, and scalability (including modeling, automation, AI/ML, systems biology, advanced manufacturing).
• Partner cross-functionally (Discovery, Development, Commercial Manufacturing, Regulatory, Marketing) to accelerate development and commercialization.
• Provide scientific leadership on CMC strategies, program decisions, regulatory interactions, and business initiatives.
• Expand external collaborations with academics, industry partners, consortia, and global health organizations; support visibility via publications and presentations.
• Guide teams through complex technical challenges across development lifecycle; consult on upstream, downstream, analytical, and manufacturing strategies.
• Mentor scientists and leaders; foster a culture of rigor, innovation, collaboration, and continuous learning.

• Ph.D. in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline.
• 15+ years industry experience in vaccine/biologics drug substance process development.
• Deep end-to-end lifecycle expertise (upstream/downstream) through commercialization.
• Experience leading CMC strategies/development programs with successful regulatory submissions/approvals.
• Strong understanding of modeling, automation, AI/ML, and systems biology; extensive knowledge of global regulatory frameworks.
• Experience with expression systems/cell substrates:
  
  E. coli, yeast, HEK
  293, Vero, CHO.

• Recognized authority with evidence of scientific impact and external recognition (publications, patents/awards, collaborations).
• Knowledge of adjuvant development and associated drug product strategies.

• Bioprocessing, bioproducts, cross-functional teamwork, innovation, mentoring, process scale-up, scientific analysis/leadership/strategizing, evaluating new technologies, GLPs.