Distinguished Scientist, Vaccines & Advanced Biotechnologies Process R&d

Merck Merck · Pharma · PA

Distinguished Scientist role in Vaccines & Advanced Biotechnologies Process R&D at Merck, focusing on the process development and clinical manufacturing of vaccine drug substances. The role involves crafting scientific strategy, fostering collaborations, mentoring talent, and advising on complex technical challenges, with a requirement for experience in CMC leadership and regulatory submissions. While AI/ML is mentioned as an area of understanding, it is not the core craft of the role.

What you'd actually do

  1. Crafting and implementing a visionary scientific strategy that encompasses the entire lifecycle of vaccine DS development and clinical manufacturing, including the creation of a forward-thinking technology roadmap.
  2. Fostering strategic partnerships across CMC areas and collaborating with Discovery, Clinical, Manufacturing, and Marketing teams to drive innovation and accelerate the commercialization of our vaccine pipeline.
  3. Building and expanding our external collaboration network with leading academic institutions, industry partners, and NGOs, while enhancing our scientific visibility through high-impact publications and keynote presentations at major conferences.
  4. Inspiring and nurturing the next generation of scientific talent through mentorship and coaching, cultivating a culture of excellence and creativity within our organization.
  5. Advising and supporting the DS development teams as they navigate critical milestones and tackle complex technical challenges, ensuring the successful advancement of our projects.

Skills

Required

  • PhD in Chemical Engineering, Biochemistry, pharmaceutical sciences, or a relevant field
  • 15+ years of experience in Drug Substance (DS) process development for vaccines/ biologics
  • Extensive DS experience in upstream, downstream, and analytical development for vaccines/biologics
  • Proficient with major cell substrates and modalities
  • Experience in CMC or program leadership leading to multiple successful regulatory submissions for vaccines/biologics
  • Excellent understanding of modeling, automation, AI/ML, and Systems Biology
  • Extensive knowledge of global regulatory requirements for vaccines
  • Demonstrated scientific and communication capability
  • Proven record of coaching talents and building high performance teams
  • Bioprocessing
  • Bioproducts
  • Cross-Functional Teamwork
  • Detail-Oriented
  • Evaluating New Technologies
  • Exercises Judgment
  • Good Laboratory Practices (GLPs)
  • Innovation
  • Mentoring Staff
  • Process Scale Up
  • Professional Networking
  • Protein Characterization
  • Protein Purifications
  • Scientific Analysis
  • Scientific Leadership
  • Strategizing

Nice to have

  • Recognized as a scientific leader nationally/internationally
  • Proven record of pushing the boundary of the vaccine/biologics field
  • Working knowledge on adjuvant development and innovation
  • Demonstrated expertise in addressing complex challenges
  • Consistently delivers breakthrough results
  • Demonstrated ability to apply and promote an innovation and growth mindset
  • Demonstrated capability and organizational intelligence to lead changes

What the JD emphasized

  • minimum of 15 years of experience in Drug Substance (DS) process development for vaccines/ biologics
  • Experience in CMC or program leadership leading to multiple successful regulatory submissions for vaccines/biologics
  • Extensive knowledge of global regulatory requirements for vaccines