Description

You will lead Quality Control activities within the PDM Analytical Development & QC department, managing outsourced QC for late-phase to commercial programs at CDMOs and contract testing labs. You will oversee method validation/transfer, stability programs, reference materials, and quality events such as OOS/OOT investigations and change controls, collaborating with cross-functional teams to support clinical and commercial programs.

Requirements

• BS or MS in Chemistry, Pharmaceutical Science or related discipline
• 6+ years of relevant industrial experience in analytical development/QC
• Solid understanding of cGMP, data integrity, QbD, and regulatory requirements
• Strong problem-solving and communication skills
• Ability to work independently and multi-task in a fast-paced environment

Responsibilities

• Manage QC activities for process validation to commercial manufacture of DS, DP, and FP
• Manage stability programs, reference materials, and raw materials at contract organizations
• Coordinate and manage outsourced QC activities at CDMOs and contract testing labs
• Manage quality events including lab investigations, deviations, change controls, and CAPAs
• Lead method validation and transfer activities at CDMOs and contract testing labs