Principal Scientist – Formulation-Dissolution

Principal Scientist – Formulation-Dissolution

Requirements

• Proven ability to learn quickly, communicate effectively, and deliver results in a fast-paced environment
• Understanding of drug product processing, drug substance physical form, dissolution testing, and biopharmaceutical modeling
• Vast knowledge of guidelines and associated recommendations (ICH, USP, etc.)
• Strong analytical technical capabilities
• Excellent communication skills
• Experience developing and authoring method justification reports, establishing specifications, and authoring justification of specifications
• Attention to detail and ability to track key information across programs
• A thorough understanding of developing and defending clinically relevant dissolution specifications
• Knowledge of various dissolution systems and apparatus types
• The ability to work successfully in both a team/matrix environment as well as independently
• The ability to work in a fast pace environment, manage priorities, communicate outcomes and maintain timelines for multiple projects
• Leadership experience, but not necessarily management experience
• Typically requires a PhD in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 4-7 years experience in life sciences, engineering or academia, or typically requires a Master’s Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 7 years experience in life sciences, engineering or academia, or typically requires a Bachelor’s Degree in pharmaceutical sciences, chemistry, chemical engineering, materials sciences or related field and 10 years experience in life sciences, engineering or academia.

Responsibilities

• Justification of clinically relevant dissolution method parameters and specifications
• Understanding of biorelevant media testing and its applications
• Understanding how drug substance physical form, solubility, and drug product processing can impact analytical methods and specifications
• Understanding of key analytical deliverables for late stage programs including method development, validation, specification setting, stability, release testing and analytical strategies to bring these individual items together collectively for a fast-paced program
• Authoring dissolution sections for regulatory submissions
• Designing validation protocols that are in compliance with ICH and FDA guidelines
• Identifying critical factors/parameters that may not be mandated by guidelines but are essential for developing a robust method and validating it for its intended use
• Communicating risk and mitigation plans
• Mentoring, training, and developing junior colleagues while working in a matrix team environment
• Authoring methods, protocols and reports as assigned
• Reviewing results to support multiple projects in parallel
• Independently designing and performing elaborate, technically challenging experiments in a resourceful manner with a high degree of reliability and attention to details
• Performing basic statistical analysis of experimental data, where appropriate
• Demonstrating knowledge of scientific principles and basic understanding of applicable drug development regulations
• Generating effective hypotheses to pursue project goals and set new experimental directions
• Identifying broad implications of results and their impact on overall study
• Developing novel and creative solutions to overcome project goal obstacles
• Helping to oversee dissolution system maintenance and troubleshooting.

Preferred Qualifications

No preferred qualifications provided.