Principal Scientist, Oral Formulation Sciences

Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling‑up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our scientists use cutting‑edge science to transform drug delivery and manufacturing technology to positively impact patients. We are looking for a passionate scientist with strong academic fundamentals who will lead CMC project teams and oversee formulation development of new chemical entities from first‑in‑human formulations through final market definition and manufacturing process robustness assessment. The role also involves driving new technology strategy, scientific understanding, and capability building within the organization. Primary Responsibilities Lead development of new, innovative approaches for product development, generate experimental designs, execute plans, and analyze data to impact pipeline development and set strategic direction. Mentor technical staff and support execution of pipeline programs. Lead due diligence of potential pipeline assets and drug delivery technologies, representing PSCS on cross‑functional teams. Set direction and coordinate technology development efforts in emerging drug‑delivery areas. Drive evaluation of new technologies and lead capability build to deploy them to pipeline assets. Collaborate within and across functional areas to develop novel drug‑delivery technologies. Act as a recognized subject‑matter expert in at least one area of drug delivery and/or drug product manufacturing technology. Maintain creative and disciplined approach to drive results. Execute formulation and process development using Design‑of‑Experiments for new chemical entities or life‑cycle management opportunities while coaching others. Coordinate development activities with chemistry, analytical, and physical characterization groups. Lead project activities at external manufacturing sites. Facilitate manufacturing, packaging and release of clinical supplies for clinical studies, assist in scale‑up at pilot and commercial scale, and summarize results in technical reports and presentations. Enhance company’s professional image through patents, presentations, publications and professional activities, advancing areas such as science and technology development, business strategic improvements, and process innovations. Build and maintain awareness of relevant and emerging technologies and capabilities to develop institutional understanding and staff across the organization. Education & Qualifications Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years relevant industry experience. M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum 10 years relevant industrial experience. B.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum 14 years relevant industrial experience. Required Experience and Skills Capable of leading formulation development activities in matrix team environments to define robust formulation and manufacturing process. Lead complex teams in development of new molecules and technologies that shape drug delivery strategy. Extensive experience with conventional and novel drug product technologies, including hands‑on experience in a pilot plant and deep scientific knowledge to train others. Recognized as a technical expert and scientific contributor with proven innovative ideas. Broad knowledge of formulation science and in-depth knowledge in multiple areas, including core understanding of the drug development process, excipient attributes, and formulation‑process interplay. Demonstrated ability to independently design, execute and lead complex experiments and data analysis. Track record of working effectively with team members of diverse skill sets and backgrounds. Strong verbal and written communication skills. Preferred Experience and Skills Prior experience leading development projects at an enterprise level. Strong mentoring capabilities to build individuals and teams. Recognized as a subject‑matter expert in multiple drug delivery and/or manufacturing technologies. Demonstrated ability to fundamentally characterize and address manufacturing challenges through development and optimization of novel production technologies. Desire to build new capabilities through evaluation of new technologies and hands‑on optimization of existing technologies. Ability to engage others to build a strong scientific community and address drug delivery challenges. Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy, and materials science to solve practical pharmaceutical development problems. Required Skills Accountability, Adaptability, Animal Vaccination, Cell Culture Process Development, Cell Line Development, Chemical Biology, Chemical Physics, Combination Products, Data Analysis, Drug Development, Finite Element Analysis, Innovative Thinking, Leadership Mentoring, Manufacturing Processes, Materials Science, Mentorship, Organic Chemistry, Pharmaceutical Development, Pharmaceutical Process Development, Process Manufacturing, Professional Collaboration, Professional Networking, Project Development, Quality by Design. Benefits Comprehensive benefits package includes medical, dental, vision, healthcare and other insurance benefits for employees and families, retirement benefits including 401(k), paid holidays, vacation, compassionate and sick days. Equal Employment Opportunity Merck is an Equal Employment Opportunity Employer and provides equal opportunities to all employees and applicants for employment. Discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics is prohibited. As a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr