Project Management Specialist - Operations (DS & DP)

Overview

This role focuses on managing end-to-end project execution within biologics operations, with emphasis on Drug Substance (DS) and Drug Product (DP) workflows. The position supports coordination across manufacturing and quality functions to help ensure timelines, compliance, and smooth batch progression.

Key Responsibilities

• Own the execution of DS and DP projects across upstream, downstream, fill-finish, and packaging activities.
• Monitor the full batch journey from raw material release through to DP release.
• Build and maintain project schedules, manage dependencies, flag risks, and escalate issues when needed.
• Coordinate closely with Manufacturing, QA, QC, MSAT, Regulatory, and Supply Chain teams.
• Track core operational metrics such as cycle time, yield, and rejection rates.
• Support initiatives aimed at improving processes and lowering operating costs.
• Help ensure all work is aligned with cGMP and applicable regulatory standards.
• Prepare dashboards, summaries, and management-level reports for review.

Education

A bachelor’s or master’s degree in Biotechnology, Life Sciences, Pharmacy, or a closely related discipline is required.

Skills and Experience

• Practical knowledge of DS and DP operations, including upstream, downstream, aseptic processing, and fill-finish.
• Ability to manage projects and handle multiple stakeholders effectively.
• Working understanding of cGMP and regulatory expectations.
• Strong analytical thinking and structured problem-solving ability.
• Good command of Excel and PowerPoint for tracking and reporting.
• Capability to deliver work on schedule and maintain governance discipline.
• Experience in improving operational efficiency and ensuring compliance.

Experience

Applicants should bring 5 to 10 years of experience in biologics, along with hands-on exposure to Drug Substance and Drug Product processes.