Principal Scientist, Process Development & Commercialization

Merck•Rahway, NJ

11d•$173,200 - $272,600

About The Position

The Principal Scientist, Process Development & Commercialization will use scientific and engineering expertise to develop safe, robust, and scalable manufacturing processes for late-stage small molecule programs, advancing them from development to commercialization. The position provides technical leadership across global networks and influences internal and external development and manufacturing strategies. The role leads and mentors technical staff responsible for process characterization studies, regulatory filing strategies, and technology transfers to commercial manufacturing sites. It applies Quality Risk Management principles, statistical design of experiments (DOE), and data-driven decision-making to support process development and commercialization. The successful candidate works in accordance with current Good Manufacturing Practices (cGMPs), participates in risk assessments and deviation investigations, and champions Good Documentation Practices (GDPs). The position requires a bachelor's or master's degree in chemical engineering or a related scientific discipline and at least 11 years of relevant process development experience, or a Ph.D. in chemical engineering or a related scientific discipline and at least 7 years of relevant experience after the doctorate. The role is regular, has a first/day shift, requires 10% travel, and offers domestic relocation and visa sponsorship. The salary range is $173,200–$272,600, with eligibility for an annual bonus and long-term incentive, if applicable.

Requirements

Bachelor's or master's degree in chemical engineering or a related scientific discipline from an accredited institution, with a minimum of 11 years of relevant process development experience; or a Ph.D. in chemical engineering or a related scientific discipline, with a minimum of 7 years of relevant experience following completion of the doctorate.
Demonstrated experience in chemical process development.
Strong communication, organizational, technical writing, interpersonal, and project management skills.
Demonstrated ability to lead technical teams and influence decision-making across multiple stakeholders.
Required skills include API manufacturing, chemical engineering, chemical industry, chemical manufacturing, chemical processes, commercialization, downstream processing, driving continuous improvement, external manufacturing, manufacturing processes, manufacturing scale-up, mentorship, pharmaceutical process development, process characterization, small molecules, statistical data analysis, and technology transfer.

Nice To Haves

Hands-on laboratory-based process development experience, including small molecule drug substance unit operations such as chemical reactions, work-up operations, isolation, and crystallization.
Experience leading technical interactions with external partners, suppliers, and contract manufacturing organizations.
Expertise in statistical experimental design and data analysis.
Familiarity with applying cGMP principles in pharmaceutical drug substance and/or drug product development and manufacturing.
Experience applying Quality by Design (QbD) principles, mathematical modeling, and engineering scale-up methodologies.
Experience supporting commercial product launches and post-approval process improvements.

Responsibilities

Develop and execute experimental programs addressing process design, robustness, scalability, productivity, and process understanding.
Lead process characterization and apply scientific principles to establish robust manufacturing processes.
Lead regulatory filing support, including process characterization, control strategy development, and process validation planning and execution.
Mentor and develop technical staff through laboratory execution, data analysis, and scientific problem-solving.
Work effectively with cross-functional teams to advance complex development programs.
Lead technical teams and influence decisions among multiple stakeholders.
Support technology transfer to commercial manufacturing sites and commercial supply activities.
Apply Quality Risk Management principles, statistical DOE, and data-driven decision-making.
Operate in accordance with cGMPs and participate in risk assessments and deviation investigations.
Champion Good Documentation Practices throughout development and manufacturing activities.