Shaailesh Gokhale

Visionary and results-driven executive with 24+ years of leadership in pharmaceutical and biotech sectors, including API and formulation manufacturing. Proven track record in business transformation, regulatory compliance, global operations, and strategic partnerships. Spearheaded multimillion-dollar expansions, driven operational excellence, and fostered innovation across complex environments.

Adept at aligning technology, people, and processes to deliver sustainable growth and regulatory success.

President Strategic Operation, Portfolio Management & API - Akums Drugs and Pharmaceuticals Ltd - India

(2025-07)

AKUMS has been number 1 CDMO in Indian since last 8 Years. Every 1/7 Tablet/Capsule (OSD) from Indian Subcontinent is Manufactured in AKUMS. Responsible for Plant Operations, OTIF, New Product Development (R&D), Regulatory Compliance, New Client acquisition and Product Approval and also independent P&L responsible for API Plant. Operational Scale: 8+ manufacturing sites | 1,600+ employees | ₹1,650+ Cr revenue footprint | Export-driven operations

• Driving global API client acquisition and CEP-led EU market expansion
• Acting as CXO sponsor for regulated-market audits and strategic customer engagements
• Positioning Akums API business for innovator + global generic CDMO mandates
• Improve OTIF from 87% to Phase 1-93% and Phase II- 95-96%
• Driving capacity expansions aligned to global automation benchmarks, digital dashboards
• Improvise energy consumption for optimization of Per 1000 Cost
• Enhance Order book Visibility (N+2) by improving OTIF
• EU Successful Approval for Plant 1.2.3.4 & 8 and CEP for API unit
• Capacity enhancement by automation and improved OEE
• Work with IT for Successful migration to S4 HANA and Asset Management System
• Revenue impact by successfully clearing Regulatory and Client Audit - New Client Acquisition
• E-Log boo and subsequently Transformation towards eBMR
• Working on Dark and Semi Dark Warehouse concepts using robotics and high-speed automated equipment
• A Green Field Facility in Zambia with CAPEX @ 450+ Cr
• Improve delivery, Revive and improve profitability (EBITDA), Revenue of API Business
• Identify and Successful Commercialization of Products for Formulation and API Business
• Improve Compliance Level of all Plants to Seek and Seal Export Business Opportunities by acquiring CEP (EU) Certification

Chief Executive Officer - Universal Medicap Ltd - Vadodara, India

(2022-04 - 2025-05)

Universal Medicap Group of companies has various businesses like Gamma Irradiation Unit, Ready to use Media Plates and Flagship Vial Rubber Closures Manufacturing near Vadodara.

Full CEO responsibility: Strategy, P&L, operations, technology, and market expansion. Responsible for to manages the entire range of technical and commercial activities including Formulation development, manufacturing operations, technology sourcing, business alliance, Strategic alliance OR Partnership, change management, & P&L responsibility for the Organization.

• Revenue growth +58% in two fiscal years; capacity utilization 53% → 68%
• Import substitution of 175+ SKUs under Make in India / Atmanirbhar Bharat
• Launched new products: Dual-chamber bungs, ETFE laminated plungers, insulin closures
• Initiated eBMR, automation & digital QA systems
• Designing EU & US-compliant injectable & PFS greenfield facility (2027 launch)
• Drove energy optimization, waste reduction, and environmental compliance initiatives
• Strengthened export-oriented operations, regulatory readiness, and sustainable manufacturing practices

Chief Operating Officer - Windlas Biotech - Dehradun, India

(2020-01 - 2022-04)

Windlas is one of the top 5 CDMO organizations in India working with many MNC customers like Pfizer, Abbott, P&G, Sanofi, Merck, etc, and repute Indian Pharma- Torrent, Intas, Zydus, Lupin, Alkem Mankind etc. Responsible for to manages the entire range of technical and commercial activities including formulation development, manufacturing operations, technology sourcing, business alliance, Strategic alliance OR Partnership, transfer, process development, process validation, commercialization, troubleshooting, strategic change management and Customer. We are currently operating five manufacturing sites and are adding another injectable site to its network. Multi-site COO role with end-to-end P&L accountability.

Operational Scale: 6+ manufacturing sites | 1,100+ employees | @ ₹735+ Cr revenue footprint | Export-driven operations

• Revenue scaled ₹327 Cr → ₹595 Cr in 3 years
• EBITDA improved 11.5% → 16.2%
• Productivity improvement ~30%, yield 89% → 97%
• Added API vertical integration (12 APIs)
• Achieved EU-GMP & SAHPRA approvals post USFDA import alert
• Delivered ₹225+ Cr injectable greenfield facility
• Supported M&A, portfolio strategy & export expansion
• Built API business from inception to ₹350–370 Cr valuation impact (Including internal Consumption)
• Expanded customer base to 280+ global pharma clients, reducing concentration risk
• Personally, supported EU-GMP, SAHPRA approvals post regulatory crisis, restoring market confidence
• Built a robust process safety and EHS-led operating culture across multiple manufacturing locations
• Centralized best-practice frameworks for quality, productivity, cost control, and compliance

Global Operations Lead India - Pfizer - Chennai, India

(2016-05 - 2020-01)

Global Enterprise Role: Provided global technical and operational leadership across regulated manufacturing networks supporting sterile Formulation, injectables, biologics, and APIs & R&D Site Operations. Led complex site integrations, technology transfers, and remediation programs across USFDA and EU-regulated sites. Partnered with global Quality, Regulatory, and Supply organizations to ensure inspection readiness, continuity of supply, and lifecycle robustness.

Multi-step chemistry, process safety, export manufacturing, and operational governance.

• Executed $100M+ CAPEX across 3 fiscal years
• Commercialized 3 monoclonal antibodies globally
• Managed hydrogenation facilities up to 200 bar
• Strengthened global compliance, FLS & automation frameworks
• Supported global M&A and alliance management
• Regulatory Compliance for Small Molecule and API Site
• New Institute Business
• P&L across all sites – 7
• Oversight of complex chemistry and high-risk operations, strengthening process safety, FLS, and EHS governance across managed global sites
• Institutionalized standardized operational and safety best practices across multi-location manufacturing networks

Head Technical Services - Fresenius Kabi Oncology - Kalyani, Gurgaon, India

(2014-11 - 2016-05)

Worked with Site Head (Sr. Vice President) for plant operations, like production scheduling/ planning, prioritization for product allocation & equipment utilization plan, incremental & continuous efforts for yield improvement, equipment allocation/occupancy plan and meeting value & volume-based target for month / quarter and ultimately for year and plant operational concern in IR/ HR. Played a key role in enabling monthly dispatches for the month at 70Cr. managed site operation in absence of site head including EH&S and supply-chain management and IR and HR functions.

Held end-to-end leadership responsibility for oncology API manufacturing, including strategy, operations, compliance, and capacity expansion. Led API operations supporting high-potency oncology products for US, EU, and ROW markets, with direct exposure to USFDA and EU-GMP regulatory frameworks.

• Cleared USFDA, MHRA, TGA audits without major observations
• Led Ops, Compliance & engineering governance, digital workflows, and energy optimization
• Drove process robustness, yield improvement, and supply reliability in complex oncology APIs
• Acted as senior interface for global regulatory audits, quality governance, and remediation programs
• Strengthened customer and internal stakeholder confidence through consistent regulatory performance and delivery reliability

Dy. General Manager - ACG Associated Capsules - Brazil, Thailand, Mumbai, India

(2011-12 - 2014-11)

Worked on various green & brownfield projects for capacity enhancement to cater domestic & international market requirement. Designed & Successfully Commercialized Manufacturing Capacity for the project 22Bn; Hard Shell Capsules per annum at LATAM and Thailand Region. The Project Cost of Brazil was @ 430+, Thailand @ 400 Cr and Pithampur @ 465 Cr. Worked with various cross-functional teams; Supply Chain, Finance, HR during setting up Green Project in LATAM and South East area

• Delivered 22 billion capsules/year capacity across LATAM & SEA
• Led ₹400–465 Cr greenfield projects
• Implemented AGVs, robotics, vision inspection & lean manufacturing
• Strengthening engineering governance, accelerating project timelines, and elevating operational resilience through intelligent automation

Sr. Manager - Project & Engineering - Biocon - Bengaluru, India

(2007-05 - 2011-12)

Senior Operations & Technology Leadership. Led scale-up and commercialization support for biologics and API programs in regulated markets. Supported global regulatory filings, audits, and lifecycle optimization initiatives. Contributed to capacity expansion, operational excellence, and cost optimization programs.

• Led biologics, injectables, fermentation & R&D greenfield projects
• Managed $100M JV biologics facility
• Successfully Led & supported FDA audits for injectable biologics

Sr. Manager - Paras Pharma (Reckitt Benckiser) - India

(2005-10 - 2007-05)

Progressive Operations, Engineering & Manufacturing Leadership.

• Hands-on exposure across OSD manufacturing, sterile operations support, utilities, validation, maintenance, and EHS systems
• Built deep operational grounding in regulated manufacturing environments and shop-floor execution

Manager - Cadila Pharma - Ahmedabad, Ethiopia, Jammu, India

(2003-09 - 2005-10)

Project Leader - Tata Honeywell - Pune, India

(2001-09 - 2003-10)

Engineer - CIPLA Limited - Mumbai, Goa, India

(1997-09 - 2001-08)

M. Tech - Chemical Engineering - IIT Delhi (1995-07 - 1997-06)

Master's in Business Administration (MBA) - Operations and Supply Chain Management - IMT Ghaziabad (2020-08 - 2022-05)

Master's in Business Administration (MBA) - Business Analytics - Liverpool John Moore University (2022-08 - 2024-02)