As General Manager & Head of Manufacturing, you will be responsible for the end-to-end leadership of the manufacturing site, ensuring consistent delivery of GMP-compliant biologics. You will lead cross-functional teams, oversee facility operations, and ensure audit readiness for global regulatory inspections (FDA, EMA, MHRA, etc.).

Key Responsibilities

Provide strategic leadership and operational oversight of all manufacturing activities.
Ensure full compliance with GMP regulations and internal quality standards.
Lead site readiness for regulatory audits and inspections, including mock audits and CAPA implementation.
Drive continuous improvement initiatives across manufacturing, quality, and supply chain functions.
Collaborate with Quality Assurance, Regulatory Affairs, and Process Development to ensure seamless tech transfer and scale-up.
Manage site budgets, staffing, and performance metrics.
Represent the site in executive leadership meetings and with external stakeholders.

Requirements

Proven leadership experience in biologics manufacturing, ideally with mammalian cell platforms.
Deep understanding of GMP regulations and audit processes (FDA, EMA, MHRA).
Track record of successful regulatory inspections and site readiness programs.
Strong operational and strategic mindset with excellent communication skills.
Bachelor’s degree in life sciences, engineering, or related field (advanced degree preferred).
Experience in CDMO or biotech environments is a plus.

BioTalent

Latest Jobs

General Manager and Site Head Manufacturing