Principal Scientist, Downstream Process Development

Merck Merck · Pharma · NJ

Principal Scientist role focused on downstream process development for biotherapeutics at Merck. The role involves designing purification processes, developing technical strategies, and innovating manufacturing technologies. It requires collaboration with cross-functional teams, publishing research, and mentoring staff. While AI/ML is mentioned as a preferred skill, it is not the core craft of the role.

What you'd actually do

  1. As an impactful contributor, shape and realize innovation across the Biologics’ pipeline, strategy, and science
  2. Advance the pipeline by collaborating with cross-functional teams, from Research & Manufacturing, in a fast-paced, multidisciplinary environment
  3. Participate in or lead 1) development of robust and scalable purification processes for biologics in different stages of clinical development, 2) process characterization and regulatory filings for successful commercialization
  4. Advance downstream processes by improving efficiency and cost effectiveness through research and innovation, while assessing technologies and industry best practices
  5. Collaborate with academia, industry, and vendors to drive development and early adoption of novel process technologies

Skills

Required

  • Adaptability
  • Artificial Intelligence (AI)
  • Biomanufacturing
  • Bioprocess Engineering
  • Career Development
  • Cell Culture Process Development
  • Cell Line Development
  • Combination Products
  • Data Analysis
  • Finite Element Analysis (FEA)
  • Innovation
  • Innovative Thinking
  • Leadership Mentoring
  • Manufacturing Operations
  • Pharmaceutical Process Development
  • Prioritization
  • Process Characterization
  • Professional Collaboration
  • Professional Networking
  • Protein Expression
  • Publishing
  • Quality by Design
  • Regulatory Filings
  • Strategic Initiative

Nice to have

  • Leadership of CMC development teams
  • Continuous biomanufacturing integrated with process-analytical technologies
  • High-throughput experimentation, automation, and process control
  • Knowledge of protein expression, analytics, conjugation chemistry and formulation
  • Biophysical, mechanistic and facility modeling
  • statistical analysis
  • data-science
  • machine learning
  • artificial intelligence

What the JD emphasized

  • Ph.D. with 6+ years, MS with 8+ years, or BS with 10+ years of industry experience and background in Chemical/Biochemical engineering, or a related field
  • Strong fundamental knowledge and subject matter expertise in downstream processing of biologics, recent advances, and challenges in the field
  • Expertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of purification process development
  • Track record of accomplishments in downstream bioprocessing with a history of peer-reviewed publications and presentations