Senior Principal Scientist, Analytical Chemistry

Position Summary

The Senior Principal Scientist will serve as a CMC Analytical Lead (CMC-AL) for drug candidates across all stages of development, as well as within the commercial product portfolio as needed. This role is a key member of cross-functional CMC teams responsible for analytical strategy development.

Role and Responsibilities

• Lead analytical strategy development as a core member of cross-functional CMC teams.
• Define product critical quality attributes and establish methods, specifications, and analytical control strategies.
• Collaborate across Analytical, Drug Substance, Drug Product, Quality, and Regulatory functions.
• Review, interpret, and communicate analytical results and conclusions.
• Author, review, and approve technical reports to support regulatory submissions.
• Respond to regulatory authority questions related to analytical strategy and data.
• Provide leadership, coaching, and mentoring to scientific staff within matrix teams.

Required Qualifications

• BS with 12–15 years, MS with 9–12 years, or PhD with 6–8 years of pharmaceutical experience in chemistry or related discipline.
• Demonstrated scientific accomplishments including publications and presentations.
• Experience with GMP and GLP requirements and risk assessment processes.
• Strong expertise in synthetic chemistry, drug substance and drug product development.
• Extensive experience in analytical method development, validation, and technical transfer.
• Experience with analytical testing across diverse dosage forms.
• Knowledge of dissolution methods and biopharmaceutical assessment.
• Familiarity with ICH and global regulatory requirements.
• Experience supporting regulatory submissions and building CMC dossiers.
• Experience with commercialization of small molecule drug products.
• Experience managing external manufacturing and testing labs.

Preferred Qualifications

• Strong communication and interpersonal skills.
• Experience working in matrixed team environments.
• Familiarity with modern laboratory equipment and automation.
• Knowledge and application of Quality by Design (QbD) principles.