Principal Scientist, Process Development & Commercialization

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

Job summary

Merck seeks a highly motivated scientist/engineer to advance late-stage small molecule programs from development to commercialization. The Principal Scientist, Engineering leads process characterization, technology transfer to manufacturing sites, and regulatory filing support while mentoring staff across Merck's global network.

You will apply DOE, QbD, and risk management within cGMPs to ensure safe, scalable manufacturing processes and collaborate across functions to influence development

Qualifications

• Bachelor's or master's degree in chemical engineering or a related scientific discipline with 11+ years of relevant experience, or a PhD with 7+ years
• Experience leading process development, characterization, and scale-up activities in pharma manufacturing
• Experience supporting regulatory filing strategies and technology transfers to commercial sites

Responsibilities

• Lead and oversee process characterization activities to develop robust manufacturing processes
• Drive regulatory filing support, including control strategy development and process validation planning/execution
• Mentor and develop technical staff through lab execution, data analysis, and problem solving
• Collaborate with cross-functional teams to drive complex development programs and decision making
• Apply QbD, DOE, and risk management principles to ensure compliant manufacturing
• Lead technology transfer activities to commercial manufacturing sites

Skills

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

Education

Bachelor's or Master's in Chemical Engineering

PhD in Chemical Engineering or related

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.

Job Description

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.

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.

Required Experience And Skills

• 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

Preferred Experience And Skills

• 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

Required Skills

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

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

Requirements

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:

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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 your rights, including under California, Colorado and other US State Acts

Salary

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.

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

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.

Requisition ID

R421339