Role Objective: The key objective of this role is to provide global strategic and operational leadership for Biotech's manufacturing network of six sites, producing sterile implantable ophthalmic devices, sterile hyaluronic-acid–based products and ophthalmic surgical consumables. The role is responsible for secure, compliant, right-first-time and cost-competitive manufacturing; delivering the production plan agreed through S&OP; driving sustained COGS and per-unit cost reduction; commissioning new capacity on time, on budget and on specification; and keeping all manufacturing sites inspection-ready at all times for US FDA, EU MDR Notified Bodies, HPRA, ANVISA, CDSCO and MDSAP. The position is the senior-most manufacturing leader in the organisation, partnering with the CEO, the senior leadership team and cross-functional teams on network strategy, investment and long-term capability building. Desired Candidate Profile: Education
• Master’s in Engineering or Pharmacy with MBA/PGDM preferred Experience & Role

Requirements:
• 20+ years of manufacturing experience in medical devices/sterile pharmaceuticals, including 8–10 years in multi-site leadership and management of large-scale, international operations.
• Strong hands-on expertise in sterile/aseptic manufacturing, terminal sterilization, sterile filling, cleanrooms, environmental monitoring, sterile filtration, bioburden control, packaging validation, and sterility assurance.
• Proven experience in greenfield/brownfield plant commissioning, manufacturing transformation, automation, site transfers, capacity planning, and business continuity.
• Strong track record in regulatory inspections, remediation, global QMS/GMP compliance, and applicable medical device, ophthalmic, implantable, sterilization, and sterile packaging standards.
• Demonstrated manufacturing excellence through Lean, Six Sigma, TPM, Kaizen, cost reduction, digital manufacturing systems, shop-floor automation, traceability, inspection,



and analytics.
• Experience in global MedTech/sterile manufacturing environments, preferably with exposure to precision manufacturing, IOLs/OVDs, sterile filling, BFS, and management of in-house and contract sterilization operations. Role &

Responsibilities:
• Own the global manufacturing strategy, network footprint and 3–5-year capacity roadmap for all sites.
• Lead, direct and hold accountable the Site Heads and central manufacturing functions — Engineering & Projects, Manufacturing Excellence, MSAT / Technology Transfer and EHS.
• Build a high-performing manufacturing leadership team, with succession plans for every Site Head and critical role.
• Keep every site permanently inspection-ready, working hand-in-hand with the independent Corporate Quality Assurance function; own site-level deviations, CAPA and root-cause analysis to closure.
• Maintain sterile / aseptic manufacturing to the highest standard — cleanroom classification and monitoring, water and HVAC systems, media fills and a contamination control strategy per EU GMP Annex 1.
• Ensure effective validation, control, and periodic revalidation of sterilization and sterile barrier packaging processes in line with applicable standards, including oversight of contract sterilization providers.
• Deliver the monthly S&OP; production plan with ≥95% schedule attainment, ensuring OTIF delivery of finished goods in partnership with Supply Chain.
• Ensure site gross margin as per approved budget and drive a per-unit cost-reduction roadmap through conversion-cost discipline,



daily production cost and yield reviews, BOM control, waste elimination, automation and capacity utilisation.
• Build a Lean / Operational Excellence culture through tiered Kaizen, TPM and Six Sigma projects with measured, audited savings, and lead the manufacturing digitalization roadmap.
• Deliver capex and expansion projects from conception to commissioning, qualification and regulatory approval — on time, on budget and on specification.
• Lead technology transfer and new product introduction from R&D; to commercial manufacturing, including scale-up, process validation and design-transfer readiness.
• Own EHS and business continuity for all sites — zero lost-time injuries, environmental compliance and tested contingency plans for critical utilities, equipment, sterilization capacity and single-site products.
• Govern manufacturing Opex and Capex budgets, support strategic investment and make-vs-buy decisions, and establish and report manufacturing KPIs for management review. Functional Skills Required
• Strong experience in multi-site sterile manufacturing network management, including capacity planning, Capex evaluation, and make-vs-buy decisions; working knowledge of SAP manufacturing and costing modules, with S/4HANA exposure preferred.
• Quality-first leadership with strong strategic thinking and financial acumen.
• Proven ability to execute transformation, develop leaders across sites, and influence senior cross-functional stakeholders. Team Size to be Handled
• Direct reports: Site Heads and Central function heads. Important Links Website: https://biotechhealthcare.com/ LinkedIn: https://www.linkedin.com/company/biotechhealthcare/ Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

📌 Vice President of Manufacturing (Ahmedabad)
🏢 Biotech Healthcare
📍 Ahmedabad