Principal Scientist, Process Development & Commercialization

MSD•Rahway, NJ

2d•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

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
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.
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: EEOC Know Your Rights EEOC GINA Supplement
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
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
Search Firm Representatives Please Read Carefully 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 place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

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.
Apply Quality Risk Management principles, statistical design of experiments (DOE), and data-driven decision making to ensure successful process development and commercialization.
Operate in accordance with current Good Manufacturing Practices (cGMPs).
Participate in risk assessments and deviation investigations.
Champion Good Documentation Practices (GDPs) throughout development and manufacturing activities.
Develop safe, robust, and scalable manufacturing processes through process characterization, technology transfer, process validation, regulatory filing support, and commercial supply activities.