Associate Principal Scientist, Molecule Chemical Engineering

Position: Associate Principal Scientist, Small Molecule Chemical Engineering
** Job Description*
* ** Associate Principal Scientist, Engineering*
* ** Chemical Commercialization Technology (CCT)*
* 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 Associate Principal Scientist, Engineering, will leverage deep scientific and engineering knowledge to develop safe, robust, scalable, and commercially viable manufacturing processes. The role encompasses process characterization, technology transfer, process validation, regulatory filing support, commercial launch readiness and global supply support for late-stage pipeline and commercial products.

The successful candidate will lead teams in the application of scientific and risk-based approaches to process understanding and control strategy development. This includes the use of Quality Risk Management (QRM), statistical design of experiments (DOE), process modeling, and data analytics to enhance process robustness and ensure reliable product supply.

This position combines laboratory and pilot-scale experimental work with direct engagement at commercial manufacturing facilities. The scientist will be expected to provide strategic technical leadership during scale-up, process validation, technology transfer and manufacturing investigations while mentoring junior scientists and engineers.

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 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.

** Position 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.

+ Ability 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.

+ Ability 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…