Associate Principal Scientist, Small Molecule Chemical Engineering

MSD Malaysia; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Job summary

Merck & Co., Inc. in Rahway, NJ seeks an Associate Principal Scientist, Engineering, Chemical Commercialization Technology (CCT) to lead development, scale-up and commercialization of small molecule drug substances.

The role blends lab work with pilot-scale activities at manufacturing facilities. Responsibilities include process characterization, QRM/QbD application, regulatory support, and tech transfer to ensure robust, compliant manufacturing.

Qualifications

• PhD in Chemical Engineering or related field with 4+ years industrial experience or BS/MS with 8+ years industrial experience.
• Experience in chemical process development and scale-up for pharma or specialty chemicals.

Responsibilities

• Lead development, scale-up and commercialization of small molecule drug substance processes.
• Design and execute process characterization studies to establish understanding and operating ranges.
• Apply QRM, QbD and statistics to develop robust control strategies.
• Provide technology transfer for pilot plant and commercial sites.
• Support process validation, continued process verification and regulatory submissions.
• Mentor junior scientists and drive cross-functional collaboration.

Skills

API Manufacturing

Bioprocessing

Chemical Engineering

Process Development

Technology Transfer

Manufacturing Scale-Up

Pharmaceutical Process Development

Process Design

Education

PhD in Chemical Engineering

BS/MS in Chemical Engineering

Tools

JMP

Minitab

Job description

Associate Principal Scientist, Engineering Chemical Commercialization Technology (CCT)

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 Associate Principal Scientist, Engineering, will leverage deep scientific and engineering knowledge to develop safe, robust, scalable and commercially viable manufacturing processes. The role encompasses process characterization, technology transfer, process validation, regulatory filing support, commercial launch readiness and global supply support for late-stage pipeline and commercial products.

The successful candidate will lead teams in the application of scientific and risk-based approaches to process understanding and control strategy development. This includes the use of Quality Risk Management (QRM), statistical design of experiments (DOE), process modeling, and data analytics to enhance process robustness and ensure reliable product supply. This position combines laboratory and pilot-scale experimental work with direct engagement at commercial manufacturing facilities. The scientist will be expected to provide strategic technical leadership during scale-up, process validation, technology transfer and manufacturing investigations while mentoring junior scientists and engineers. 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.

Key Responsibilities

• Lead technical development, scale-up and commercialization of small molecule drug substance manufacturing processes.
• Design and execute process characterization studies to establish process understanding and define commercial operating ranges.
• Apply Quality Risk Management (QRM), Quality by Design (QbD) and statistical methodologies to develop robust control strategies.
• Provide technical leadership for technology transfer activities to pilot plant and commercial manufacturing sites.
• Support process validation, continued process verification, regulatory submissions and post-approval change implementation.
• Collaborate effectively with Manufacturing, Process Research, Quality, Regulatory, Supply Chain and external partners to resolve complex technical issues.
• Lead investigations associated with process deviations, yield improvements, impurity control and process robustness.
• Mentor and develop junior scientists and engineers through technical coaching and project leadership.
• Drive innovation through the application of advanced process technologies, digital tools, modeling and data analytics where appropriate.

Position Qualifications

Education
Ph.D. in Chemical Engineering or a related scientific discipline with a minimum of 4 years of relevant industrial experience following completion of the Ph.D. OR B.S. or M.S. in Chemical Engineering or a related scientific discipline with a minimum of 8 years of relevant industrial experience.

Required Experience and Skills
• Demonstrated expertise in chemical process development and scale-up for pharmaceutical or specialty chemical manufacturing.
• Proven ability to independently design, execute, interpret and communicate experimental studies aimed at improving process understanding, robustness, productivity and control strategy development.
• Experience supporting technology transfer from laboratory development through pilot plant and commercial manufacturing.
• Strong technical leadership and project management capabilities in cross-functional environments.
• Ability to mentor and develop scientists and engineers through technical guidance and coaching.
• Excellent written, verbal and presentation communication skills.
• Strong organizational and time-management skills with the ability to manage multiple priorities.
• Demonstrated problem‑solving capabilities using scientific and engineering principles.
• Ability to collaborate effectively across technical, quality, regulatory and manufacturing functions.

Preferred Experience and Skills

Hands-on experience with unit operations commonly employed in small molecule drug substance API development and manufacturing, including chemical reactions, workup operations, filtration, drying, crystallization and particle engineering.
Experience leading process characterization, validation strategy development, and process performance qualification (PPQ) activities.
Experience authoring or contributing to regulatory submissions and responding to health authority questions.
Expertise in statistical experimental design and data analysis tools (e.g., JMP, Minitab or equivalent).
Experience supporting commercial manufacturing, lifecycle management and post-approval process changes.
Familiarity with mathematical modeling, process simulation, mechanistic understanding and scale-up principles.
Experience working with external manufacturing partners and contract development/manufacturing organizations (CDMOs).
Knowledge of cGMP requirements and pharmaceutical manufacturing operations.
Experience applying digital, data science or advanced manufacturing technologies to accelerate process development and commercialization.

Required Skills

API Manufacturing, Bioprocessing, Chemical Engineering, Chemical Processes, Commercialization, Manufacturing, Manufacturing Processes, Manufacturing Scale-Up, Manufacturing Technologies, Pharmaceutical Process Development, Process Design, Process Development (PD), Small Molecule Drugs, Technology Transfer

Preferred Skills

API Manufacturing, Bioprocessing, Chemical Engineering, Chemical Processes, Commercialization, Manufacturing, Manufacturing Processes, Manufacturing Scale-Up, Manufacturing Technologies, Pharmaceutical Process Development, Process Design, Process Development (PD), Small Molecule Drugs, 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.

Equal Employment Opportunity

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.

Right to Work and Visa

Employee Status: Regular
VISA Sponsorship: Yes

Benefits

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.

Salary

The salary range for this role is $142,400.00 - $224,100.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Job Posting End Date

09/10/2026

Company

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.

Legal and Compliance

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.