Tech Stack

Description

You will provide analytical support to API process research and development, formulation development, and assist in regulatory filings for pipeline compounds. You'll oversee analytical development activities at contract partners, collaborate with cross-functional teams, and contribute to control strategies and regulatory submissions.

Requirements

• Ph.D. with 5+ years industry experience or MS with 8+ years in analytical development
• Technical knowledge of HPLC/UPLC, XRPD, LCMS, DSC, DVS, Dissolution
• Experience managing projects at CROs/CDMOs
• Experience with analytical method development, validation, and method transfer
• Knowledge of regulatory submissions (IND, IMPD, NDA) and ICH/GMP guidelines

Responsibilities

• Oversee analytical development activities at contract partners
• Provide analytical support for API process R&D and formulation development
• Establish control strategy and set specifications for drug substances and products
• Prepare and review study protocols, reports, and CMC regulatory submission documents
• Communicate technical findings in cross-functional project team meetings