Senior Downstream NPI & Tech Transfer Lead

MSD Malaysia; Dunboyne; On-site; EUR 150,000 - 230,000; Full time

Job summary

MSD Malaysia's Dunboyne site seeks a senior technical leader to guide DS/NPI programs, oversee technology transfer, PPQ, regulatory filings, and launch readiness. The role spans cross-site support, troubleshooting, and lifecycle management.

You will lead investigations, drive CAPA, and ensure robust control strategies while mentoring staff and maintaining GMP compliance across all suites. Strong leadership and strategic vision are essential.

Qualifications

• B.S., M.S., or Ph.D. in a relevant Engineering or Scientific discipline.
• A minimum of 6 years’ experience within biopharmaceutical manufacturing and/or development.
• Demonstrated technical excellence with deep expertise in biologics molecules, Downstream manufacturing processes, process equipment, and automation.
• Proven experience in biologics drug substance development, technical operations, and new product introduction.
• Strong communication, presentation, and stakeholder–management capabilities, with the ability to influence at all levels of the organization.
• A track record of effective cross–divisional collaboration and matrix leadership.
• Experience operating within a GMP manufacturing environment, including regulatory filings, investigations, quality notifications, and CAPA management.
• Solid business acumen, including an understanding of product lifecycle management, financial stewardship, and the ability to manage multiple complex programs simultaneously.
• A strong sense of urgency, resilience, and change agility, combined with an engaging and motivational leadership style.

Responsibilities

• Provide strategic technical leadership and coaching to DS subteam leads and staff at the Dunboyne site across clinical manufacturing and commercial operations.
• Own full technical accountability across all phases of technology transfer from gap analysis to launch readiness.
• Develop robust control strategies ensuring manufacturability of biologics products.
• Provide hands–on SME support during PPQ, early production, and transitions to new manufacturing nodes.
• Lead investigations including deviations, OOS/OOT events, and contamination incidents with data–led root cause analysis and CAPA.
• Oversee cross–programme trend detection, process monitoring, risk reviews, and knowledge management with regulatory support.
• Act as Sending Unit for post–Transition–to–Supply technology transfers to ensure continuity of knowledge across the network.
• Manage downstream technical lifecycle for in–line commercial products, driving continuous improvement and robustness.

Skills

Biopharmaceutical

Downstream manufacturing

Technical leadership

Regulatory filings

GMP experience

Cross-functional collaboration

Process automation

Stakeholder management

Education

Bachelor/Master/PhD in engineering or science

PhD preferred

Job description

MSD Malaysia's Dunboyne site seeks a senior technical leader to guide DS/NPI programs, oversee technology transfer, PPQ, regulatory filings, and launch readiness. The role spans cross-site support, troubleshooting, and lifecycle management.

You will lead investigations, drive CAPA, and ensure robust control strategies while mentoring staff and maintaining GMP compliance across all suites. Strong leadership and strategic vision are essential.