Distinguished Scientist, Vaccines & Advanced Biotechnologies Process R&D
Merck
The Opportunity
- Serve as the scientific architect for vaccine drug substance process development and clinical manufacturing; establish and drive forward-looking scientific strategy.
Key Responsibilities
- 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.
Required Qualifications
- 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, HEK293, Vero, CHO.
Preferred Qualifications
- Recognized authority with evidence of scientific impact and external recognition (publications, patents/awards, collaborations).
- Knowledge of adjuvant development and associated drug product strategies.
Required Skills
Bioprocessing, bioproducts, cross-functional teamwork, innovation, mentoring, process scale-up, scientific analysis/leadership/strategizing, evaluating new technologies, GLPs.
Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline shown on posting).