09 Oct
|
Biotech Healthcare
|
Ahmedabad
09 Oct
Biotech Healthcare
Ahmedabad
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 safe, 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 recent 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 analytic
📌 Vice President of Manufacturing (Ahmedabad)
🏢 Biotech Healthcare
📍 Ahmedabad