Merck & Co.-posted 9 months ago
$114,700 - $180,500/Yr
Full-time • Mid Level
Onsite • Rahway, NJ
Chemical Manufacturing

The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking a highly motivated and technically focused individual to serve as crystallization subject matter expert. The incumbent will develop isolation processes that deliver desired solid-state properties, purity, and yield for clinical programs across our diverse pipeline. This role involves the development of new technologies focused on improving the efficiency of laboratory crystallization development and aims to provide greater process understanding. The application of state-of-the art tools, including process analytical technology (PAT) and process modeling, will be integral to the position. Developing subject matter expertise in drying, milling operations, and particle size control, including execution of wet and dry milling experiments, is expected. The position involves hands-on process development and scale-up work performed at scales spanning benchtop and commercial manufacturing sites. Under scientific direction, the incumbent will perform independent research which involves conceiving, designing, planning, and implementing advanced studies aimed at achieving mechanistic understanding that informs rational process design for the isolation of Active Pharmaceutical Ingredients (APIs) and drug substance intermediates. The candidate may also have the opportunity to manage crystallization development and/or manufacturing activities at external suppliers. The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), participating in risk assessments, deviation investigations, and Good Documentation Practices (GDocP). Highly effective communication and collaboration skills are critical to success because the role has broad impact across the organization. Specifically, the role includes considerable cross-functional collaboration as part of integrated drug substance and drug product teams that collectively drive decisions regarding API form and physical attributes. Mentoring of chemistry and engineering colleagues to share best practices and guide development toward successful outcomes is a central expectation of the role.

  • Develop isolation processes that deliver desired solid-state properties, purity, and yield for clinical programs.
  • Develop new technologies to improve laboratory crystallization development efficiency.
  • Apply process analytical technology (PAT) and process modeling.
  • Develop expertise in drying, milling operations, and particle size control.
  • Perform hands-on process development and scale-up work.
  • Conduct independent research to achieve mechanistic understanding for rational process design.
  • Manage crystallization development and/or manufacturing activities at external suppliers.
  • Exhibit a mindset of safety and quality compliance.
  • Participate in risk assessments, deviation investigations, and Good Documentation Practices (GDocP).
  • Collaborate cross-functionally within integrated drug substance and drug product teams.
  • Mentor chemistry and engineering colleagues.
  • BS and/or MS in Chemical/Biochemical Engineering (or comparable) plus at least 5 years of relevant work experience in crystallization process development, or a PhD in Chemical/Biochemical Engineering (or comparable).
  • Hands-on laboratory experience (> 2 years) performing chemical process development, including crystallization process development and/or solid state analysis.
  • Experience with crystallization specific Process Analytical Technology (i.e. FTIR, FBRM, Raman, Easyviewer).
  • Ability to balance cross-functional work across multiple projects.
  • Highly effective communication and collaboration skills.
  • Experience with process scale-up and/or technology transfer.
  • Background with chemical engineering-related technology development.
  • Familiarity with kilo-scale laboratory equipment.
  • Experience with process modeling (e.g., population balance modeling, distillation modeling).
  • Knowledge with milling equipment (spiral jet mills, pin mills, co-mills, rotor-stator wet mills).
  • Experience with organic chemical synthesis and wet chemistry.
  • Understanding of pharmaceutical drug substance processing.
  • Familiarity with drug product processing.
  • Familiarity with concepts and application of cGMP during pharmaceutical development and production.
  • A high level of innovation, creativity, and self-initiative.
  • Bonus eligibility
  • Long term incentive if applicable
  • Health care and other insurance benefits (for employee and family)
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Sick days
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