Tech Stack

Description

You will act as the late-stage drug product subject matter expert, supporting process validation and commercialization. You'll work with CDMOs to ensure robust manufacturing strategies for consistent commercial supply of solid dosage forms.

Requirements

• PhD in pharmaceutics or related field with 3+ years experience, or MS with 6+ years, or BS with 10+ years
• Proven track record in drug product process validation and solid dosage form manufacturing
• Experience with QbD principles and DOE methodology preferred
• Understanding of cGMP/ICH guidelines
• Experience managing outsourcing at CDMOs to meet CMC goals

Responsibilities

• Support drug product Process Validation, scale up, and post-approval changes (SUPAC) at CDMOs
• Identify critical process parameters and implement process controls
• Draft, coordinate, execute validation protocols and author/review reports
• Provide technical review of deviations, change controls, and process monitoring
• Support regulatory filings and represent drug product group as SME in audits