Production Head- Injectable Production

Role & responsibilities

The AVP Technical Operations (Production – Injectables) will lead end-to-end sterile manufacturing operations for injectable dosage forms (SVP/LVP, Vials, Ampoules, PFS, Cartridges, Lyophilized products). The role is responsible for ensuring compliant, efficient, and cost-effective production aligned with global regulatory standards (USFDA, EU-GMP, MHRA, WHO, etc.), while driving operational excellence, quality culture, and continuous improvement across the site.

This position plays a critical leadership role in scaling capacity, managing regulatory inspections, technology transfers, and ensuring consistent delivery of high-quality sterile products to global markets.

Key Responsibilities

1. Production & Manufacturing Oversight

• Lead sterile manufacturing operations including compounding, filtration, aseptic filling, lyophilization, terminal sterilization, and visual inspection.
  
• Ensure adherence to cGMP, data integrity, and aseptic practices.
  
• Oversee production planning execution to meet OTIF (On-Time In-Full) delivery targets.
  
• Monitor batch cycle times, yield, OEE, and capacity utilization.
  
• Drive zero critical deviations and contamination control excellence.
  

2. Regulatory Compliance & Quality Assurance

• Ensure compliance with USFDA, EMA, MHRA, WHO, and other applicable regulatory authorities.
  
• Lead regulatory inspections, internal audits, and customer audits.
  
• Review and approve SOPs, batch manufacturing records (BMR), protocols, and validation documentation.
  
• Oversee deviation management, CAPA implementation, change control, and risk assessment processes.
  
• Ensure robust Environmental Monitoring (EM) and sterility assurance systems.
  

3. Technical Operations & Engineering

• Oversee equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, and revalidation.
  
• Lead technology transfers for new products from R&D or external sites.
  
• Support commissioning and scale-up of new sterile lines or facility expansions.
  
• Drive automation, digital manufacturing initiatives, and MES implementation (if applicable).
  

4. Operational Excellence & Continuous Improvement

• Implement Lean, Six Sigma, and operational excellence frameworks.
  
• Optimize manpower productivity and reduce operational costs.
  
• Improve Right First Time (RFT), reduce batch failures and deviations.
  
• Implement contamination control strategy (CCS) and lifecycle validation programs.
  

5. People Leadership & Development

• Lead, mentor, and develop production, engineering, and validation teams.
  
• Build strong GMP and quality-driven culture across departments.
  
• Establish succession planning and competency development programs.
  
• Ensure adherence to EHS standards and promote safe working practices.
  

6. Financial & Strategic Responsibilities

• Manage production budgets, CAPEX, and OPEX.
  
• Drive cost optimization initiatives without compromising compliance.
  
• Support strategic planning for capacity expansion and new product introduction.
  
• Participate in make-vs-buy decisions and contract manufacturing evaluations.
  

Key Performance Indicators (KPIs)

• Zero critical regulatory observations
  
• Batch rejection rate
  
• OEE improvement %
  
• Deviation closure timelines
  
• OTIF performance
  
• Cost per batch reduction
  
• Audit readiness score
  
• Environmental Monitoring compliance trends
  

Qualifications & Experience

Education:

• Bachelor’s / Master’s degree in Pharmacy, Chemical Engineering, Biotechnology, or related field.
  
• Advanced certifications in GMP/Quality/Lean Six Sigma preferred.
  

Experience:

• 20–30 years in pharmaceutical manufacturing.
  
• Minimum 8–10 years in sterile injectables production leadership.
  
• Proven experience handling USFDA/EU audits.
  
• Experience in large-scale aseptic manufacturing facility.
  

Technical Competencies

• Sterile manufacturing processes (aseptic & terminal sterilization)
  
• Lyophilization process understanding
  
• HVAC & cleanroom management
  
• Contamination control strategy
  
• Media fills & aseptic process simulation
  
• Process validation lifecycle
  
• Risk management (ICH Q9)
  
• Data integrity principles
  
• SAP/MES systems exposure
  

Behavioral Competencies

• Strategic thinker with operational depth
  
• Strong regulatory and compliance mindset
  
• Decisive leadership under pressure
  
• Cross-functional collaboration
  
• Crisis management capability
  
• High ownership and accountability
  

Preferred Experience

• Exposure to PFS and Cartridge filling lines
  
• Experience in biologics injectables (desirable)
  
• Greenfield project or facility expansion leadership
  
• Global stakeholder management experience
  

Working Conditions

• Sterile manufacturing environment (Grade A/B/C/D areas)
  
• Flexible working hours during audits or critical production cycles
  
• Travel for regulatory interactions or corporate meetings (if applicable)