Principal Scientist, Process Development & Commercialization

MSD Malaysia; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist, Engineering to lead late-stage small molecule manufacturing development, technology transfer, validation, and regulatory filing support across global sites.

You will mentor staff, apply QbD and DOE, drive process characterization, risk assessments, GDP, and work with cross-functional teams to deliver robust, scalable processes for commercial supply.

Qualifications

• Bachelor’s or master’s degree in chemical engineering with at least 11 years experience.
• Experience leading process development and characterization activities.
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• Experience supporting regulatory filings and process validation.
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• Mentoring and developing technical staff in a cross-functional setting.

Responsibilities

• Lead process characterization studies and DOE to establish robust manufacturing processes.
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• Drive technology transfer to commercial manufacturing sites.
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• Develop and execute regulatory filing strategies and process validation planning.
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• Mentor and develop technical staff within laboratory and cross-functional teams.

Skills

Process development

Regulatory filing

Mentoring

DOE

cGMP

Cross-functional leadership

Education

Bachelor's or master's in chemical engineering

PhD in Chemical Engineering

Tools

QbD principles

Job description

Job Description Job Summary: 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.

Position Qualifications: Education 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

• 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

• 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

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about you'' rights, including under California, Colorado and other US State Acts

The salary range for this role is $173,200.00 - $272,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

The application deadline for this position is stated on this posting.

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

Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 10/22/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.