Associate Principal Scientist, Small Molecule Chemical Engineering

About the role

The Chemical Commercialization Technology (CCT) department, part of our Manufacturing Division, is seeking a highly motivated and collaborative scientist to join our team. This position offers the opportunity to provide technical leadership across a varied portfolio of late-stage small molecule development programs while working in a highly integrated environment with research, manufacturing, quality, regulatory and external partners.

Responsibilities

• Lead technical development, scale-up, and commercialization of small molecule drug substance manufacturing processes.
• Design and execute process characterization studies to establish process understanding and define commercial operating ranges.
• Apply Quality Risk Management (QRM), Quality by Design (QbD) and statistical methodologies to develop robust control strategies.
• Provide technical leadership for technology transfer activities to pilot plant and commercial manufacturing sites.
• Support process validation, continued process verification, regulatory submissions and post-approval change implementation.
• Collaborate effectively with Manufacturing, Process Research, Quality, Regulatory, Supply Chain and external partners to resolve complex technical issues.
• Lead investigations associated with process deviations, yield improvements, impurity control and process robustness.
• Mentor and develop junior scientists and engineers through technical coaching and project leadership.
• Drive innovation through the application of advanced process technologies, digital tools, modeling and data analytics where appropriate.

Qualifications

• Education: Ph.D. in Chemical Engineering or a related scientific discipline with a minimum of 4 years of relevant industrial experience following completion of the Ph.D. OR B.S. or M.S. in Chemical Engineering or a related scientific discipline with a minimum of 8 years of relevant industrial experience.
• Required Experience and Skills:
  • Demonstrated expertise in chemical process development and scale-up for pharmaceutical or specialty chemical manufacturing.
  • Proven ability to independently design, execute, interpret, and communicate experimental studies aimed at improving process understanding, robustness, productivity and control strategy development.
  • Experience supporting technology transfer from laboratory development through pilot plant and commercial manufacturing.
  • Strong technical leadership and project management capabilities in cross-functional environments.
  • Able to mentor and develop scientists and engineers through technical guidance and coaching.
  • Excellent written, verbal, and presentation communication skills.
  • Strong organizational and time-management skills with the ability to manage multiple priorities.
  • Demonstrated problem-solving capabilities using scientific and engineering principles.
  • Able to collaborate effectively across technical, quality, regulatory and manufacturing functions.
• Preferred Experience and Skills:
  • Hands-on experience with unit operations commonly employed in small molecule drug substance API development and manufacturing, including chemical reactions, workup operations, filtration, drying, crystallization and particle engineering.
  • Experience leading process characterization, validation strategy development, and process performance qualification (PPQ) activities.
  • Experience authoring or contributing to regulatory submissions and responding to health authority questions.
  • Expertise in statistical experimental design and data analysis tools (e.g., JMP, Minitab, or equivalent).
  • Experience supporting commercial manufacturing, lifecycle management, and post-approval process changes.
  • Expertise in mathematical modeling, process simulation, mechanistic understanding and scale-up principles.
  • Experience working with external manufacturing partners and contract development/manufacturing organizations (CDMOs).
  • Knowledge of cGMP requirements and pharmaceutical manufacturing operations.
  • Experience applying digital, data science, or advanced manufacturing technologies to accelerate process development and commercialization.