The Scientist 1 designs and executes experiments, analyzes data, and contributes to the development and optimization of pharmaceutical formulations and processes. 

Core Responsibilities 

• 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. 

• Contribute to scale-up and technology transfer activities by supporting engineering studies and data analysis. 

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

• Ensure proper calibration and maintenance of laboratory equipment and instruments. 

• Collaborate with cross-functional teams including analytical, manufacturing, and quality to advance projects. 

• Present results at project meetings and provide scientific input to guide project direction. 

• Ensure adherence to GLP/GMP and safety requirements in all experimental activities. 

• Draft Master Batch Records and development methods. 

• Interface with clients prior to and during development batches. 

• Other duties as assigned. 

Technical Competencies 

• Competence in pharmaceutical sciences, including formulation development and analytical methods, with emphasis on solid oral dosage forms containing small molecule drugs. 

• Ability to design 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. 

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

• Understanding of material science attributes—such as particle size, morphology, hygroscopicity, and polymorphism—and their impact on solid oral dosage form quality and performance. 

• Proficient in technical writing and documentation for scientific and regulatory purposes, including protocols, reports, and development summaries. 

• Knowledge of regulatory guidelines for early-phase development and CMC documentation, particularly as they relate to solid oral dosage forms. 

Behavior Competencies 

• Analytical thinker who works independently and collaboratively as part of a team. 

• Communicates scientific information clearly to colleagues and stakeholders. 

• Adaptable and responsive to project changes and evolving priorities. 

• Demonstrates initiative and curiosity in exploring new ideas and approaches. 

• Manages multiple tasks and meets project deadlines effectively. 

Education and Experience Requirements 

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutics, or related field. 

• 2–5 years of experience in pharmaceutical research or development. 

• Experience in formulation and process development is advantageous.