Sr. Manager - Production API

Ipca; Munger; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

Ipca seeks a senior API manufacturing leader to drive regulatory compliance, production scale-up, and operational excellence at the Munger plant. You will mentor shift managers and engineers while leading Lean/Six Sigma initiatives, CAPA programs, and safety/EHS processes, including PSM, with a focus on regulatory liaison experience.

The role requires 15+ years in API manufacturing and a proven track record in tech transfers from R&D to commercial scale, delivering safe, compliant operations and

Qualifications

• Minimum 15+ years of core API manufacturing experience.
• Experience leading USFDA/regulatory audits.
• Experience with technology transfers from R&D to manufacturing.
• Strong leadership of shift teams, engineers and operators.

Responsibilities

• Regulatory Compliance: Lead the plant through USFDA audits and investigate deviations with robust CAPAs.
• Production & Scale-Up: Execute commercial production schedules, optimize yields, and lead tech transfers to scale.
• Operational Excellence: Drive Lean/Six Sigma initiatives to reduce cycle times and control budgets.
• Safety & EHS: Enforce Process Safety Management and safely handle hazardous reactions.
• Team Leadership: Mentor and manage a team of shift managers, engineers and plant operators.

Skills

Lean/Six Sigma

Process Safety Management

Regulatory compliance

CapA management

Team leadership

Technology transfer

Job description

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.