Biologics Development & Commercialization Director

MSD; Pennsylvania; Híbrido; USD 173.000 - 273.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Bonus & long-term incentives

Descripción de la vacante

Merck & Co. in the United States seeks a Director for Biologics Development and Commercialization to lead the DCT and advance a robust CMC strategy for the portfolio.

You will influence governance, lead cross-functional teams, and ensure on-time tech transfers, regulatory filings, and uninterrupted supply for commercial products. The ideal candidate has deep biologics CMC experience, strong leadership, strategic thinking, and a proven track record in commercialization and regulatory compliance

Formación

• Advanced degree requirements as listed: BS with 15+ years, MS with 12, or PhD with 10 years.
• Strong cross-divisional leadership and strategic planning for biologics.
• Experience with cGMP and regulatory submissions.

Responsabilidades

• Lead Development and Commercialization Team (DCT) to deliver end-to-end CMC programs.
• Coordinate with DS, DP, Regulatory, QA, and Supply Chain.
• Mitigate risks and drive governance decisions.
• Ensure robust tech transfers and filing/approvals.

Conocimientos

Biologics Development

CMC Leadership

Regulatory Strategy

Tech Transfer

Cross-Functional Leadership

Risk Management

Project Management

Strategic Thinking

Team Leadership

Commercialization

Quality Systems

Supply Chain

Educación

PhD in Biological Sciences

MS in related field

BS in engineering or science

Descripción del empleo

Merck & Co. in the United States seeks a Director for Biologics Development and Commercialization to lead the DCT and advance a robust CMC strategy for the portfolio.

You will influence governance, lead cross-functional teams, and ensure on-time tech transfers, regulatory filings, and uninterrupted supply for commercial products. The ideal candidate has deep biologics CMC experience, strong leadership, strategic thinking, and a proven track record in commercialization and regulatory compliance