Analyst, MS&T

Overview

Manage Contract Manufacturing Organization (CMO) in the following areas : commercial product  manufacturing (Drug Substance, Drug Product & Packaging), and testing laboratories (Quality Control for  stability, In-Process & Release testing).

Primarily responsible for the following, but not limited to; strategy establishment and implementation of New product(s) launch, tech transfer, method / process / packaging validation, etc.

Manage CPM project financial tracking.

Ensure an uninterrupted supply of commercial product(s) to the marketplace.

Responsibilities

Technical Management

• Manage and monitor production & testing activities in CMOs and handle associated issues.
• Perform technical review of CMOs’ protocols / reports, Master / Production batch records, testing methods, certificate of analysis, and change control.
• Provide technical insights and support during investigations of deviations as Subject Matter Expert (SME).
• Author / coordinate change controls and investigations accordingly.
• Author, review, monitor and maintain SOPs / Guidelines.
• Manage archiving of GMP documents related to commercial manufacturing / packaging and testing.
• Lead process improvement initiatives at CMOs to improve quality and contribute to Cost of Goods reduction.
• Lead trending / monitoring programs at CMOs : continued process verification, annual product report, and stability trending.
• Lead commercial readiness activities : validation (Analytical, Process & Packaging), risk assessment (critical process parameter), annual stability program template.
• Assist in writing and preparation of regulatory submission documents : drug product and drug substance sections in NDA, Annual reports, and other regulatory dossiers.
• Assist in inspection or audit from Board of Health or SK LSI (review of CMC documents, etc.), as subject matter expert.

Financial Management

Communications Management

Qualifications