Project Management Specialist - Operations (DS & DP)

Key Responsibilities -

• Lead DS & DP project execution (upstream, downstream, fill-finish, packaging)
• Track batch lifecycle from RM release to DP release
• Manage project plans, timelines, risks, and escalation
• Drive cross-functional coordination (MFG, QA, QC, MSAT, Regulatory, SCM)
• Monitor KPIs: cycle time, yield, rejection rates
• Drive process improvements and cost optimization initiatives
• Ensure compliance with cGMP and regulatory requirements
• Prepare dashboards and management reports

Education -

Bachelor’s / Master’s in Biotechnology, Life Sciences, Pharmacy, or related field

Skills -

• Strong knowledge of DS (upstream/downstream) and DP (aseptic, fill-finish)
• Project management and stakeholder handling
• cGMP and regulatory understanding
• Analytical and problem-solving skills
• Proficiency in Excel, PowerPoint
• On-time project execution
• Improved operational efficiency
• Strong governance and reporting
• Compliance adherence

Experience -

5–10 years of experience in Biologics, with hands-on knowledge of Drug Substance (DS) and Drug Product (DP) processes.