Senior Scientist, Small Molecule Chemical Engineering Full-time

Senior Scientist Chemical Commercialization Technology

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.

The Senior Scientist will apply chemical engineering and process development expertise to support the commercialization of late-stage and commercial small molecule drug substance processes. This role provides significant technical leadership and offers opportunities to influence process design, control strategies, technology transfers, validation programs, regulatory submissions, and lifecycle process improvements.

The successful candidate will work across laboratory, pilot plant, and manufacturing environments to develop scientific understanding, assess process risks, and implement robust manufacturing solutions. The individual will collaborate with internal stakeholders and external partners to drive successful commercialization and continuous improvement initiatives.

The candidate must demonstrate a strong commitment to safety, quality, and compliance, including adherence to current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), data integrity principles, and participation in risk assessments, deviation investigations, change control activities and continuous improvement initiatives.

Key Responsibilities

• Lead process understanding, characterization, and commercialization activities for small molecule drug substance manufacturing processes.
• Design and execute scientifically sound experimental programs using Quality Risk Management (QRM) and Quality by Design (QbD) principles.
• Apply statistical methods, Design of Experiments (DoE), and data-driven decision making to establish process robustness and control strategies.
• Develop, defend, and communicate technical recommendations to cross-functional teams, manufacturing sites, and senior leadership.
• Support technology transfer activities from development laboratories to pilot plants and commercial manufacturing facilities.
• Author and review technical reports, validation documents, regulatory filing content, control strategies, and lifecycle management documentation.
• Provide technical leadership during process performance qualification (PPQ), process validation, and commercial manufacturing campaigns.
• Lead or support investigations, risk assessments, change controls, deviations, and corrective and preventive actions (CAPAs).
• Collaborate with internal and external manufacturing partners to resolve technical challenges and implement process improvements.
• Utilize first-principles engineering, process modeling, and scale-up methodologies to support manufacturing and process optimization.
• Champion a culture of safety, compliance, operational excellence, and continuous improvement.

Position Qualifications

Education

• Ph.D. in Chemical Engineering or a related scientific discipline.
• OR B.S. or M.S. in Chemical Engineering or a related scientific discipline with a minimum of 5 years of relevant industrial experience.

Required Experience and Skills

• Demonstrated experience in chemical process development, commercialization, or manufacturing support of small molecule pharmaceutical processes.
• Experience designing and executing experimental programs to solve complex chemical engineering and manufacturing challenges.
• Effective communication skills with the ability to present technical information to multiple audiences.
• Ability to work independently while collaborating effectively in multidisciplinary teams.
• Strong organizational, project management, and technical writing skills.
• Demonstrated commitment to safety, quality, and compliance.

Preferred Experience and Skills

• Experience authoring or reviewing regulatory submissions (e.g., NDA, MAA, post-approval changes).
• Experience leading technology transfers between development, pilot plant, and commercial manufacturing environments.
• Hands-on expertise with unit operations commonly used in small molecule drug substance manufacturing, including; Chemical reactions, Work-up operations, Distillation, Crystallization, Filtration, Drying.
• Knowledge of statistical software and advanced data analysis tools (e.g., JMP, Minitab, Python).
• Experience applying Design of Experiments (DoE), Process Capability Analysis, and Multivariate Data Analysis.
• Familiarity with process analytical technologies (PAT), digital manufacturing tools, and advanced process monitoring approaches.
• Experience leading internal / external technical discussions.
• Knowledge of current Good Manufacturing Practices (cGMP), validation requirements, and pharmaceutical quality systems.
• Experience with mathematical modeling, process simulation, scale-up principles, and engineering calculations.
• Familiarity with ICH guidelines, Quality by Design (QbD), Quality Risk Management (QRM), and lifecycle process verification concepts.

Required Skills:

API Manufacturing, Chemical Engineering, Chemical Manufacturing, Commercialization, Design of Experiments (DOE), Manufacturing Processes, Manufacturing Technologies, Pharmaceutical Process Development, Process Control, Process Improvements, Process Scale Up, Product Commercialization, Small Molecule Synthesis, Technology Development, Technology Transfer

Preferred Skills: