Senior Scientist, Engineering- Small Molecule Drug Substance Process Development
Merck, Rahway, NJ, United States
Job Overview
The Chemical Commercialization Technology (CCT) department, part of the Manufacturing Division, seeks a self‑motivated Senior Scientist, Engineering to leverage scientific/technical experience in developing safe and robust manufacturing processes for small‑molecule pipeline projects. The role includes process characterization, technology transfer, validation, filing, and supply support for late‑stage projects, with hands‑on experimentation at laboratory and kilo‑lab scales and transfer to commercial manufacturing facilities.
Key Responsibilities Develop and execute experimental programs to address process design, robustness, and productivity issues. Utilize Quality Risk Management methodologies and tools for statistical design of experiments. Conduct risk assessments, deviation investigations, and ensure compliance with cGMP, GDP, and other quality documentation practices. Collaborate within cross‑functional process development teams and guide internal/external technical discussions.
Qualifications
Education: BS/MS with a minimum of 5 years relevant experience or PhD in Chemical Engineering from an accredited institution.
Experience in chemical process development, including: experimental program design, process robustness, productivity, effective communication, collaboration, organization, interpersonal, writing, and time‑management skills; operating within a cross‑functional process development team.
Preferred: Lab‑based research/process development, regulatory file authoring, validation planning and execution, guiding technical discussions, familiarity with statistical design and analysis tools, experience with process scale‑up and technology transfer, GMP experience, mathematical modeling, theoretical scaling calculations, and Quality by Design principles.
Required Skills: Bioreactors, cGMP Regulations, Chemical Engineering, Chemical Technology, Chromatographic Techniques, Data Analysis, DOE, GMP, Manufacturing Processes, Process Development, Process Optimization, Process Scale Up, Small Molecules, Technology Transfer.
Preferred Skills: (Industry‑specific technical competencies, if applicable).
Compensation and Benefits Salary range: $117,000 – $184,200. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, 401(k), paid holidays, vacation, compassionate and sick days.
Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid model consisting of three onsite days (Monday–Thursday) and remote work on Friday, unless business‑critical tasks require an onsite presence. This model does not apply to field‑based, manufacturing‑based, research‑based positions or positions covered by collective‑bargaining agreements, nor to roles designated as "remote".
Location and Equal Opportunity Statement US and Puerto Rico residents only. San Francisco residents will be considered for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles residents will be considered for employment in compliance with the City of Los Angeles Fair Chance Initiative. Merck employs a nondiscriminatory policy and guarantees equal employment opportunity for all qualified applicants regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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. We comply with affirmative action requirements for protected veterans and individuals with disabilities.
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Key Responsibilities Develop and execute experimental programs to address process design, robustness, and productivity issues. Utilize Quality Risk Management methodologies and tools for statistical design of experiments. Conduct risk assessments, deviation investigations, and ensure compliance with cGMP, GDP, and other quality documentation practices. Collaborate within cross‑functional process development teams and guide internal/external technical discussions.
Qualifications
Education: BS/MS with a minimum of 5 years relevant experience or PhD in Chemical Engineering from an accredited institution.
Experience in chemical process development, including: experimental program design, process robustness, productivity, effective communication, collaboration, organization, interpersonal, writing, and time‑management skills; operating within a cross‑functional process development team.
Preferred: Lab‑based research/process development, regulatory file authoring, validation planning and execution, guiding technical discussions, familiarity with statistical design and analysis tools, experience with process scale‑up and technology transfer, GMP experience, mathematical modeling, theoretical scaling calculations, and Quality by Design principles.
Required Skills: Bioreactors, cGMP Regulations, Chemical Engineering, Chemical Technology, Chromatographic Techniques, Data Analysis, DOE, GMP, Manufacturing Processes, Process Development, Process Optimization, Process Scale Up, Small Molecules, Technology Transfer.
Preferred Skills: (Industry‑specific technical competencies, if applicable).
Compensation and Benefits Salary range: $117,000 – $184,200. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, 401(k), paid holidays, vacation, compassionate and sick days.
Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid model consisting of three onsite days (Monday–Thursday) and remote work on Friday, unless business‑critical tasks require an onsite presence. This model does not apply to field‑based, manufacturing‑based, research‑based positions or positions covered by collective‑bargaining agreements, nor to roles designated as "remote".
Location and Equal Opportunity Statement US and Puerto Rico residents only. San Francisco residents will be considered for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles residents will be considered for employment in compliance with the City of Los Angeles Fair Chance Initiative. Merck employs a nondiscriminatory policy and guarantees equal employment opportunity for all qualified applicants regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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. We comply with affirmative action requirements for protected veterans and individuals with disabilities.
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