Senior Scientist

Role Summary

Senior Scientist – Analytical Development, GPD. Location: Durham, NC. Lead analytical method development, validation, product characterization, and investigative testing for oral solid dosage forms, with potential work on inhaled products. Drive laboratory capability development, support regulatory submissions, and promote adoption of AI/ML tools to enhance data interpretation and workflow efficiency.

Responsibilities

• Lead and perform analytical method development, validation, product characterization, and routine investigational and clinical release testing, working on inhaled and oral products, as needed.
• Establish, equip, and optimize laboratory setups for oral solid dosage (OSD) testing capabilities.
• Provide technical and strategic input on analytical issues relevant to OSD and other modalities/dosage formats (e.g., inhaled, parenteral).
• Author and review analytical documentation to support regulatory submissions, ensuring GMP/GxP compliance and responding to regulatory inquiries.
• Champion laboratory automation technologies to improve efficiency and reliability in sample preparation, method execution, and data analysis.
• Demonstrate an active interest in using AI/ML and other data science tools to enhance analytical results interpretation and workflow performance.

Qualifications

• Required: Bachelor’s degree in Analytical Chemistry, Pharmaceutical Sciences, or a closely related field.
• Required: 8–10 years of experience with a Bachelor's degree, or 4–6 years with a master’s degree.
• Required: 8 years of experience working with oral solid dosage forms.
• Required: Strong background in analytical development for oral solid dosage forms; preferred experience with inhaled products.
• Required: Demonstrated experience in method development, validation, and application in the pharmaceutical industry.
• Required: Experience with regulatory submission processes and writing/reviewing analytical sections with responses to regulatory inquiries.
• Required: Hands-on proficiency with workflow optimization; automation experience is preferred.
• Required: Excellent organizational, problem-solving, and collaborative communication skills.
• Required: Experience working in a GMP/GxP environment.
• Required: Strong people, organizational, and communication skills (written and oral).
• Preferred: Exposure to analytical strategies across modalities/dosage formats (oral solid and inhaled).
• Preferred: Familiarity with applying data science tools, including AI/ML, to advance analytical interpretation and data flow.
• Preferred: Experience collaborating in cross-functional global teams.
• Preferred: Consistent track record in analytical method lifecycle management.
• Preferred: Experience with validation lifecycle management of laboratory automation to meet GxP requirements.

Skills

• Analytical method development and validation
• Product characterization and investigative testing
• GxP and GMP compliance
• Laboratory automation and workflow optimization
• AI/ML for data interpretation and workflow efficiency
• Regulatory writing and support for submissions
• Cross-functional collaboration in global teams
• Data analytics and problem-solving

Education

• Bachelor’s degree in Analytical Chemistry, Pharmaceutical Sciences, or closely related field
• Master’s degree (optional, if applicable for experience requirements)