About the Role We are seeking a dynamic and experienced Block Head to lead one of our key production blocks within the injectable manufacturing facility. This leadership role is critical in driving excellence across planning, execution, compliance, and cross-functional coordination. Key Responsibilities: Production Leadership: Oversee the end-to-end manufacturing operations for a designated injectable production block, ensuring adherence to production plans, quality standards, and regulatory expectations. People Management: Lead, mentor, and develop a team of production staff by managing scheduling, skills development, and performance, while fostering a culture of accountability and continuous improvement. Process Optimization: Drive process excellence through periodic reviews, SOP enhancements, and implementation of best practices to improve yield, efficiency, and throughput. Regulatory Audit Readiness: Act as a key functional representative during regulatory inspections (USFDA, EU, etc.) by ensuring thorough preparedness, leading document reviews, and addressing observations related to the production block. Compliance & Quality Assurance: Ensure all operations are aligned with cGMP standards and regulatory guidelines. Support readiness for internal and external audits and inspections. Change Implementation: Execute validated changes related to product, process, equipment, and facility, including participation in technology transfers and scale-up activities. Equipment & Maintenance Oversight: Monitor equipment performance, coordinate with maintenance teams for timely interventions, and ensure equipment qualifications and calibrations are completed as per schedule. Cross-functional Coordination: Collaborate effectively with Quality Assurance, Engineering, Supply Chain, and EHS to ensure seamless execution of production and support activities. Inventory & Resource Management: Maintain optimal inventory levels for raw materials, consumables, and WIP to support uninterrupted manufacturing. What We’re Looking For: Degree in Pharmacy, Engineering, or related field. Proven experience in sterile/injectable manufacturing (aseptic, lyo & terminal sterilization preferred). Strong leadership and team management capabilities. Sound knowledge of regulatory guidelines (USFDA, EU). Hands-on exposure to production equipment, QMS systems, and shop floor excellence tools. If you are ready to take ownership of a production block and drive results in a fast-paced, quality-driven environment, we’d love to hear from you. We are an equal opportunity employer committed to creating an inclusive workplace where diversity is valued and respected. We welcome applications from individuals of all backgrounds and experiences, regardless of race, gender, age, disability, religion, or sexual orientation.
Job Title
Associate Director-Sterile Manufacturing