Principal Scientist, Technical Director - Process Engineering - Oral Solid Dosage, Clinical Man[...]

Role Overview Position: Principal Scientist / Sr. Principal Scientist / Technical Director – Process Engineering for the Oral Solids Dosage (Non‑Sterile) team at the FLEx Center, Rahway, NJ. The FLEx Center is a pilot GMP facility for development of small molecule, biologics, and vaccine drug products. Responsibilities Own FLEx interactions across CMC project teams, overseeing the manufacturability assessment of first‑in‑human formulations to final market formulation, defining scaling and control strategies in partnership with Oral Formulation Sciences and Pharmaceutical Commercialization Technologies. Lead development of new, innovative approaches for product and process development, including design of experiments and data analysis to impact pipeline development and strategic direction. Mentor a team of process engineers, fostering scientific growth and supporting execution of pipeline programs. Provide technical oversight and direction to immediate and indirect teams to support continuous improvement and operational excellence. Coordinate development and manufacturing activities with Oral Formulation Sciences, chemistry, analytical, and physical characterization groups. Enhance the company’s professional image through patents, presentations, publications, and professional activities, advancing science, technology and business process innovation. Required Experience and Skills Extensive knowledge and proven expertise in GMP drug product processing, particularly for solid oral dosage forms, with experience on‑the‑floor activities, process robustness & validation, root‑cause analysis, change control, and deviation management. Recognized subject‑matter expert and scientific contributor in multiple drug deliveries and/or manufacturing technologies. Demonstrated high‑impact contributions, including publications, advisory seats, or industry‑university consortia participation. Track record of operating in a fast‑paced manufacturing environment, resolving technical issues while meeting customer needs in a compliant manner. Strong coordination, communication, and supervision skills, with the ability to lead and coach others on all technical issues. Deep knowledge of cGMP, FDA, EMA, and other international regulatory requirements. Experience supporting GMP audits, responding to observations, and owning CAPAs that address opportunity areas. Ability to apply principles of physical/organic chemistry, physical pharmacy, engineering, and materials science to solve practical pharmaceutical problems. Breadth and depth of experience in related functional areas, including formulation, analytical sciences, and commercialization. Experience leading process development activities in matrix team environments to define robust manufacturing processes for traditional and/or unconventional formulations. Demonstrated ability to independently design, execute, and lead complex experiments and data analysis. Strong verbal and written communication skills. Education Bachelor of Science in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences, or related field with a minimum of 14 years of relevant experience. Master’s degree with 10 years of relevant experience. PhD with 8 years of relevant experience. Preferred Experience and Skills Extensive hands‑on experience with conventional and novel drug product technologies for pipeline development, with deep understanding of scientific principles. Knowledge of formulation science and excipient attributes, and formulation‑process interplay. Understanding of connectivity between clinical development, chemistry, manufacturing and control (CMC) and commercial marketing. Experience leading enterprise‑level development projects. Strong mentoring capabilities to build individuals and teams. Benefits Salary range: $173,200.00 – $272,600.00. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive package including medical, dental, vision, retirement 401(k), paid holidays, vacation and compassionate/sick days. Additional benefits are available at the company benefits website. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination. We comply with affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr MSD Malaysia