Principal Scientist, Process Development & Commercialization

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.

• 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

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

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.

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The salary range for this role is

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.