Director, Manufacturing
Core
Director of Manufacturing responsible for aseptic and non-aseptic pharmaceutical production, ensuring cGMP compliance, and leading continuous improvement initiatives at a global biopharma services site.
Role type
Senior IC manufacturing director (pharmaceuticals)
Builds
Pharmaceutical products (aseptic and non-aseptic) for biopharma clients
Domain
Biopharmaceutical manufacturing / CDMO
Required skills
cGMP compliance, aseptic manufacturing, lean/continuous improvement, regulatory inspection management, root cause analysis, strategic planning, team leadership, safety management
Preferred skills
CDMO experience, lyophilized product experience, FDA/ICH/EU regulations knowledge, fill/finish experience
Technologies
cGMP systems, Lean methodologies, regulatory compliance frameworks
Responsibilities
Oversee daily manufacturing operations and ensure cGMP compliance; Act as technical expert for complex manufacturing issues; Lead projects and develop long-term manufacturing plans; Manage production teams and direct reports; Participate in regulatory inspections and client audits; Identify gaps and implement action plans for operational goals.
Seniority
Director, strategic leadership & hands-on management
