Anil Nilkanth

Results-driven pharmaceutical manufacturing leader with 24+ years of progressive experience in API and intermediate production. Currently heading pharma operations at Excel Industries Ltd., managing a team of 100+ personnel across production, quality, maintenance, and EHS functions. Delivered measurable impact — improved production yield from 68% to 75%, achieved annual cost savings of Rs. 2 lakhs, and reduced equipment downtime from 36 to 24 hours.

Successfully cleared USFDA audit with zero observations. Seeking a Plant Head / GM Operations role in the Pharma / API manufacturing sector where deep regulatory expertise, operational discipline, and team leadership can drive plant-level excellence.

Sr. Production Manager — Pharma Head - Excel Industries Ltd. - Chiplun, Maharashtra

(2022-04)

API & Intermediate Manufacturing Plant

• Lead end-to-end production operations for an API and pharmaceutical intermediate manufacturing plant, managing a team of 100+ personnel including shift incharges, block incharges, and workers.
• Improved production yield from 68% to 75% through process optimization, tighter parameter controls, and operator training initiatives.
• Achieved annual cost savings of Rs. 2 lakhs by identifying and eliminating process inefficiencies and material wastage.
• Reduced equipment breakdown downtime from 36 hours to 24 hours through proactive maintenance scheduling and root cause analysis.
• Successfully introduced and scaled up 3 new API products at plant level in coordination with R&D and Regulatory Affairs teams.
• Drove preparation and successful execution of USFDA audit with zero observations / critical findings — a benchmark achievement.
• Direct cross-functional coordination with QC, Warehouse, Maintenance, QA, and Marketing to ensure on-time, on-quality production delivery.
• Oversee monthly production reports tracking manufacturing quantity vs. actuals, equipment utilization, CCFs, and deviations.
• Ensure process validation, calibration records, SOP/BMR documentation, and change control are fully compliant and audit-ready.

Production Manager - Deccan Nutraceuticals Pvt. Ltd. - Pune, Maharashtra

(2021-08 - 2022-03)

USFDA Approved API & Intermediate Plant

• Managed production operations at a USFDA-approved API and Intermediate manufacturing facility.
• Ensured compliance with USFDA standards and maintained GMP documentation across all production activities.
• Coordinated with QA and QC teams for batch record reviews, CAPA, and deviation resolution.

Deputy Manager — Production - Megafine Pharma (P) Ltd. - Nashik, Maharashtra

(1999-02 - 2021-07)

WHO & cGMP Approved API & Intermediate Plant

• Progressed from production operator through shift incharge to Deputy Manager over a 22-year tenure, demonstrating sustained performance and growth.
• Handled full lifecycle of chemical operations including reactions, distillation, hydrogenation, and column separation.
• Operated and maintained reactors (SS/GLR), centrifuges, tray dryers, VTD, RCVD, ANFD, filters, multimill, and blenders.
• Led production teams through multiple WHO, cGMP, and customer audits over the tenure, consistently achieving compliance.
• Proficiently developed and reviewed BMRs, SOPs, validation documents, change control, CAPA, and deviation records.
• Coordinated with QA for process validation, cleaning validation, and new equipment qualifications.
• Conducted in-house training programs for production personnel on GMP, safety, and process excellence.

Production Associate - Spectrum Ether Ltd. - Nashik, Maharashtra

(1998-08 - 1999-01)

• Gained foundational experience in chemical manufacturing and production floor operations.

M.Sc. Chemistry (Post Graduate) - Chemistry

B.Sc. Chemistry (Graduate) - Chemistry