Principal Scientist

The Principal Scientist provides high-level technical expertise, leading and executing critical research and development efforts and shaping scientific strategy for the organization. 

Core Responsibilities 

• Serve as technical lead for complex projects, guiding formulation and process development strategy from concept through commercialization. 

• Define scientific direction for new programs and ensure alignment with business objectives and portfolio priorities. 

• Plan and perform experiments to develop drug formulations, processing methods, and analytical assays. 

• Generate and interpret data; adjust experimental plans based on findings and scientific rationale. 

• Write technical documents such as protocols, study reports, and CMC sections for regulatory submissions. 

• Evaluate and integrate cutting-edge technologies and external collaborations to advance scientific capabilities. 

• Represent the organization at scientific conferences, client meetings, and technical forums as a subject matter expert. 

• Review and critique scientific literature and competitor technologies to inform program direction and innovation. 

• Mentor scientists and support succession planning within the R&D team by developing future leaders. 

• Contribute to long-term strategic planning for the research and development portfolio. 

• Ensure compliance with quality and regulatory standards across research activities and promote a culture of scientific excellence. 

• Draft Master Batch Records. 

• Interface with clients prior to and during development batches. 

• Other duties as assigned. 

Technical Competencies 

• Deep expertise in pharmaceutical sciences with a focus on solid oral dosage forms containing small molecule drugs, coupled with awareness of current industry trends, emerging technologies, and regulatory expectations. 

• Expertise in formulation principles and process development specific to solid oral dosage manufacturing (e.g., blending, granulation, compression, encapsulation, coating). 

• Ability to design and troubleshoot experiments, execute the preparation of prototypes, and apply statistical tools for data analysis and interpretation, including evaluation of dissolution, disintegration, hardness, friability, and related performance metrics. 

• Ability to integrate external scientific and technical insights—such as novel excipients, advanced processing technologies, and predictive modeling—into development strategies to expand organizational capabilities and drive innovation in oral solid dosage forms. 

• Strong track record of innovation and successful product development for solid oral dosage forms across all stages, from preclinical to commercial launch, including lifecycle management. 

• Proficiency in scientific communication, including peer-reviewed publications, conference presentations, client interactions, and thought leadership within the solid oral dosage field. 

• Knowledge of global regulatory landscapes and ability to translate scientific understanding into strategic development and risk-mitigation plans for oral solid dosage research programs. 

Behavioral Competencies 

• Fosters a culture of scientific excellence and continuous learning across the organization. 

• Develops future leaders and mentors across departments and disciplines. 

• Demonstrates adaptability and open-mindedness to new ideas and changing landscapes. 

• Collaborates effectively across internal and external networks to build partnerships and drive projects. 

Education and Experience Requirements 

• PhD with 10 years of experience, or equivalent combination of education and experience, in pharmaceutical sciences. 

• Recognized authority in specialized areas of pharmaceutical research, evidenced by publications and industry contributions. 

• Experience leading cross-functional research initiatives and external collaborations.