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.