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 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.
- Solid 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:

1. Own the global manufacturing strategy, network footprint and 3–5-year capacity roadmap for all sites.
2. Lead, direct and hold accountable the Site Heads and central manufacturing functions — Engineering & Projects, Manufacturing Excellence, MSAT / Technology Transfer and EHS.
3. Build a high-performing manufacturing leadership team, with succession plans for every Site Head and critical role.
4. 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.
5. 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.
6. 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.
7. Deliver the monthly S&OP; production plan with ≥95% schedule attainment, ensuring OTIF delivery of finished goods in partnership with Supply Chain.
8. 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.
9. Build a Lean / Operational Excellence culture through tiered Kaizen, TPM and Six Sigma projects with measured, audited savings, and lead the manufacturing digitalization roadmap.
10. Deliver capex and expansion projects from conception to commissioning, qualification and regulatory approval — on time, on budget and on specification.
11. Lead technology transfer and new product introduction from R&D; to commercial manufacturing, including scale-up, process validation and design-transfer readiness.
12. 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.
13. 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