Distinguished Scientist, Vaccines & Advanced Biotechnologies Process R&D
Merck
13 hours ago
On-site
West Point, PA
Operations
Responsibilities:
- Lead Drug Substance (DS) process development and clinical manufacturing strategy for the vaccine pipeline, including a technology roadmap across the DS lifecycle.
- Build cross-CMC partnerships and collaborate with Discovery, Clinical, Commercial Manufacturing, and Marketing to accelerate commercialization.
- Expand external collaborations with academia, industry partners, and NGOs; enhance scientific visibility via publications and keynote presentations.
- Mentor and coach scientific talent; cultivate a culture of excellence and creativity.
- Advise DS teams on critical milestones and complex technical challenges; represent the organization in due diligence, regulatory input, and program leadership.
Education:
- PhD in Chemical Engineering, Biochemistry, pharmaceutical sciences, or a relevant field.
Required Experience And Skills:
- 15+ years in vaccine/biologics DS process development across the product lifecycle.
- Extensive upstream, downstream, and analytical development experience for vaccines/biologics; working knowledge of drug product development and clinical manufacturing.
- Experience with major cell substrates (e.g., E. coli, yeasts, HEK293, Vero, CHO) and modalities (e.g., LVV, viral vectors, RNA, protein subunits, conjugates).
- CMC or program leadership leading to multiple successful regulatory submissions.
- Knowledge of modeling, automation, AI/ML, and Systems Biology.
- Deep knowledge of global vaccine regulatory requirements.
- Ability to influence senior leaders; coaching and team-building.
Preferred:
- National/international recognition for vaccine/biologics process development.
- Experience with adjuvant development and innovation.
Required Skills (listed): Bioprocessing, cross-functional teamwork, detail-oriented work, evaluating new technologies, GLPs, innovation, mentoring, process scale-up, professional networking, protein characterization/purification, scientific analysis/leadership, strategizing.
Benefits:
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Lead Drug Substance (DS) process development and clinical manufacturing strategy for the vaccine pipeline, including a technology roadmap across the DS lifecycle.
- Build cross-CMC partnerships and collaborate with Discovery, Clinical, Commercial Manufacturing, and Marketing to accelerate commercialization.
- Expand external collaborations with academia, industry partners, and NGOs; enhance scientific visibility via publications and keynote presentations.
- Mentor and coach scientific talent; cultivate a culture of excellence and creativity.
- Advise DS teams on critical milestones and complex technical challenges; represent the organization in due diligence, regulatory input, and program leadership.
Education:
- PhD in Chemical Engineering, Biochemistry, pharmaceutical sciences, or a relevant field.
Required Experience And Skills:
- 15+ years in vaccine/biologics DS process development across the product lifecycle.
- Extensive upstream, downstream, and analytical development experience for vaccines/biologics; working knowledge of drug product development and clinical manufacturing.
- Experience with major cell substrates (e.g., E. coli, yeasts, HEK293, Vero, CHO) and modalities (e.g., LVV, viral vectors, RNA, protein subunits, conjugates).
- CMC or program leadership leading to multiple successful regulatory submissions.
- Knowledge of modeling, automation, AI/ML, and Systems Biology.
- Deep knowledge of global vaccine regulatory requirements.
- Ability to influence senior leaders; coaching and team-building.
Preferred:
- National/international recognition for vaccine/biologics process development.
- Experience with adjuvant development and innovation.
Required Skills (listed): Bioprocessing, cross-functional teamwork, detail-oriented work, evaluating new technologies, GLPs, innovation, mentoring, process scale-up, professional networking, protein characterization/purification, scientific analysis/leadership, strategizing.
Benefits:
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.