Analytical Development - Manager / Sr. Manager

Role Overview:

• The Senior Manager will join the Analytical Development Team within CMC, reporting to a Director.
• This role executes late-stage development activities for Phase III trials through commercial activities.
• Candidates must work independently and manage outsourced analytical activities at contract sites.

Responsibilities:

• Manage CDMOs for analytical development and QC for drug substance and product.
• Oversee analytical documentation in Quality Management System.
• Author CMC regulatory content for US and rest of world submissions.
• Manage GMP stability studies and reference standard programs.

Qualifications:

• At least 7 years of experience in analytical development in pharma.
• Proven leadership managing analytical chemists externally.
• Proficiency in HPLC, LC/MS, GC, USP dissolution, and method validation.
• Knowledge of CMC regulatory requirements and IND/IMPD filings.