Sr. Manager - Production API

Role & responsibilities

• Regulatory Compliance: Lead the plant through USFDA/regulatory audits; investigate deviations and implement robust CAPAs.
• Production & Scale-Up: Execute the commercial production schedule, optimize product yields, and lead technology transfers from R&D to commercial scale.
• Operational Excellence: Drive Lean/Six Sigma initiatives to reduce cycle times, control budgets, and minimize equipment downtime.
• Safety & EHS: Enforce strict Process Safety Management (PSM) and safely manage hazardous chemical reactions.
• Team Leadership: Mentors and manages a team of shift managers, engineers, and plant operators.

Preferred candidate profile

Minimum 15+ years of core API manufacturing experience.