Senior Scientist, Small Molecule Chemical Engineering
Merck
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Benefits offered by this job
Job summary
Merck in Rahway, NJ is seeking a Senior Scientist to lead cross-functional efforts in small molecule drug substance development and commercialization. You will drive process understanding, risk-based design, and robust transfer from development to manufacturing across lab, pilot plant, and production environments.
The role emphasizes cGMP, data integrity, and lifecycle optimization, with collaboration across research, manufacturing, quality, regulatory, and external partners."
Qualifications
- Demonstrated experience in chemical process development, commercialization, or manufacturing support of small molecule pharmaceutical processes.
- Experience designing and executing experimental programs to solve complex chemical engineering and manufacturing challenges.
- Strong communication and ability to work in multidisciplinary teams; commitment to safety and compliance.
Responsibilities
- Lead process understanding, characterization, and commercialization activities for small molecule drug substance manufacturing processes.
- Design and execute scientifically sound experimental programs using Quality Risk Management (QRM) and Quality by Design (QbD) principles.
- Apply statistical methods, Design of Experiments (DoE), and data-driven decision making to establish process robustness and control strategies.
- Develop, defend, and communicate technical recommendations to cross-functional teams, manufacturing sites, and senior leadership.
- Support technology transfer activities from development laboratories to pilot plants and commercial manufacturing facilities.
- Author and review technical reports, validation documents, regulatory filing content, control strategies, and lifecycle management documentation.
- Provide technical leadership during process performance qualification (PPQ), process validation, and commercial manufacturing campaigns.
- Lead or support investigations, risk assessments, change controls, deviations, and corrective and preventive actions (CAPAs).
- Collaborate with internal and external manufacturing partners to resolve technical challenges and implement process improvements.
- Utilize first-principles engineering, process modeling, and scale-up methodologies to support manufacturing and process optimization.
- Champion a culture of safety, compliance, operational excellence, and continuous improvement.
Skills
Education
Tools
Job description
The Chemical Commercialization Technology (CCT) department, part of our Manufacturing Division, is seeking a highly motivated and collaborative scientist to join our team. This position offers the opportunity to provide technical leadership across a varied portfolio of late-stage small molecule development programs while working in a highly integrated environment with research, manufacturing, quality, regulatory and external partners. The Senior Scientist will apply chemical engineering and process development expertise to support the commercialization of late-stage and commercial small molecule drug substance processes. This role provides significant technical leadership and offers opportunities to influence process design, control strategies, technology transfers, validation programs, regulatory submissions, and lifecycle process improvements. The successful candidate will work across laboratory, pilot plant, and manufacturing environments to develop scientific understanding, assess process risks, and implement robust manufacturing solutions. The individual will collaborate with internal stakeholders and external partners to drive successful commercialization and continuous improvement initiatives. The candidate must demonstrate a strong commitment to safety, quality, and compliance, including adherence to current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), data integrity principles, and participation in risk assessments, deviation investigations, change control activities and continuous improvement initiatives.
- Lead process understanding, characterization, and commercialization activities for small molecule drug substance manufacturing processes.
- Design and execute scientifically sound experimental programs using Quality Risk Management (QRM) and Quality by Design (QbD) principles.
- Apply statistical methods, Design of Experiments (DoE), and data-driven decision making to establish process robustness and control strategies.
- Develop, defend, and communicate technical recommendations to cross-functional teams, manufacturing sites, and senior leadership.
- Support technology transfer activities from development laboratories to pilot plants and commercial manufacturing facilities.
- Author and review technical reports, validation documents, regulatory filing content, control strategies, and lifecycle management documentation.
- Provide technical leadership during process performance qualification (PPQ), process validation, and commercial manufacturing campaigns.
- Lead or support investigations, risk assessments, change controls, deviations, and corrective and preventive actions (CAPAs).
- Collaborate with internal and external manufacturing partners to resolve technical challenges and implement process improvements.
- Utilize first-principles engineering, process modeling, and scale-up methodologies to support manufacturing and process optimization.
- Champion a culture of safety, compliance, operational excellence, and continuous improvement.
- Ph.D. in Chemical Engineering or a related scientific discipline.
- B.S. or M.S. in Chemical Engineering or a related scientific discipline with a minimum of 5 years of relevant industrial experience.
- Demonstrated experience in chemical process development, commercialization, or manufacturing support of small molecule pharmaceutical processes.
- Experience designing and executing experimental programs to solve complex chemical engineering and manufacturing challenges.
- Effective communication skills with the ability to present technical information to multiple audiences.
- Ability to work independently while collaborating effectively in multidisciplinary teams.
- Strong organizational, project management, and technical writing skills.
- Demonstrated commitment to safety, quality, and compliance.
- Experience authoring or reviewing regulatory submissions (e.g., NDA, MAA, post-approval changes).
- Experience leading technology transfers between development, pilot plant, and commercial manufacturing environments.
- Hands-on expertise with unit operations commonly used in small molecule drug substance manufacturing, including; Chemical reactions, Work-up operations, Distillation, Crystallization, Filtration, Drying.
- Knowledge of statistical software and advanced data analysis tools (e.g., JMP, Minitab, Python).
- Experience applying Design of Experiments (DoE), Process Capability Analysis, and Multivariate Data Analysis.
- Familiarity with process analytical technologies (PAT), digital manufacturing tools, and advanced process monitoring approaches.
- Experience leading internal / external technical discussions.
- Knowledge of current Good Manufacturing Practices (cGMP), validation requirements, and pharmaceutical quality systems.
- Experience with mathematical modeling, process simulation, scale-up principles, and engineering calculations.
- Familiarity with ICH guidelines, Quality by Design (QbD), Quality Risk Management (QRM), and lifecycle process verification concepts.
API Manufacturing, Chemical Engineering, Chemical Manufacturing, Commercialization, Design of Experiments (DOE), Manufacturing Processes, Manufacturing Technologies, Pharmaceutical Process Development, Process Control, Process Improvements, Process Scale Up, Product Commercialization, Small Molecule Synthesis, Technology Development, Technology Transfer
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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We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
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
Regular
Domestic
Yes
10%
Not Applicable
1st - Day
No
n/a
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R414642
The salary range for this role is $117,000.00 - $184,200.00. 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.
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