Principal Scientist, Process Development & Commercialization

MSD • Rahway, NJ

1d • $173,200 - $272,600 • Onsite

About The Position

Our Company is seeking a highly motivated and collaborative scientist/engineer to join our team. This is a unique opportunity to play a key role in advancing late-stage small molecule programs from development to commercialization while leading highly visible technical initiatives across our global network.

The Principal Scientist, Engineering position leverages scientific and engineering expertise to develop safe, robust, and scalable manufacturing processes through process characterization, technology transfer, process validation, regulatory filing support, and commercial supply activities. This role offers significant technical leadership, exposure to cross-functional decision-making, and opportunities to influence both internal and external development and manufacturing strategies.

The successful candidate will lead and mentor technical staff responsible for planning and executing process characterization studies, developing regulatory filing strategies, and implementing technology transfers to commercial manufacturing sites. In addition, you will apply Quality Risk Management principles, statistical design of experiments (DOE), and data-driven decision making to ensure successful process development and commercialization.

A strong commitment to safety, quality, and compliance is essential. The successful candidate will operate in accordance with current Good Manufacturing Practices (cGMPs), participate in risk assessments and deviation investigations, and champion Good Documentation Practices (GDPs) throughout development and manufacturing activities.

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 experience in process development; or 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, including developing and executing experimental programs to address process design, robustness, scalability, productivity, and process understanding.
• Leading process characterization activities and applying scientific principles to establish robust manufacturing processes.
• Leading regulatory filing support activities, including process characterization, control strategy development, and process validation planning and execution.
• Mentoring and developing technical staff through laboratory execution, data analysis, and scientific problem-solving.
• Working effectively within cross-functional teams to drive complex development programs.
• Strong communication, organizational, technical writing, interpersonal, and project management skills.
• Demonstrated ability to lead technical teams and influence decision-making across multiple stakeholders.
• 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
• Technology Transfer

Nice To Haves

• Hands-on experience in laboratory-based process development, including unit operations commonly used in small molecule drug substance development 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 the application of 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.
• Current Employees apply HERE
• Current Contingent Workers apply HERE
• US and Puerto Rico Residents Only
• San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
• Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Responsibilities

• Lead and mentor technical staff responsible for planning and executing process characterization studies, developing regulatory filing strategies, and implementing technology transfers to commercial manufacturing sites.
• Apply Quality Risk Management principles, statistical design of experiments (DOE), and data-driven decision making to ensure successful process development and commercialization.
• Operate in accordance with current Good Manufacturing Practices (cGMPs), participate in risk assessments and deviation investigations, and champion Good Documentation Practices (GDPs) throughout development and manufacturing activities.
• Advance late-stage small molecule programs from development to commercialization.
• Lead highly visible technical initiatives across our global network.
• Develop safe, robust, and scalable manufacturing processes through process characterization, technology transfer, process validation, regulatory filing support, and commercial supply activities.
• Provide significant technical leadership, exposure to cross-functional decision-making, and opportunities to influence both internal and external development and manufacturing strategies.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree