Job Title: Head of Manufacturing – API Location: Atchutapuram, Andhra Pradesh Department: Manufacturing Reports To: Managing Director Experience Required: 20+ years in API manufacturing Education: B.Sc. / M.Sc. in Chemistry or B.E. / B.Tech. in Chemical Engineering (Master’s preferred) Job Summary: The Head of Manufacturing – API will lead all API production activities to ensure safe, compliant, and efficient manufacturing operations. This role is responsible for achieving production targets, maintaining cGMP compliance, and driving continuous improvement across the API manufacturing units. Key Responsibilities: 1. Production Management • Plan and execute API manufacturing as per production schedules. • Ensure adherence to batch production records (BMRs) and standard operating procedures (SOPs). • Optimize process yields and reduce production cycle time. • Review and approve production documentation. 2. Compliance & Quality Assurance • Ensure full compliance with cGMP, ICH, and regulatory requirements (USFDA, EMA, WHO, etc.). • Coordinate with QA/QC for timely release and in-process quality checks. • Support regulatory inspections and customer audits. • Implement corrective and preventive actions (CAPAs) and change controls. 3. Team Leadership & Development • Lead and manage a team of production managers, supervisors, and operators. • Provide training and performance management to manufacturing staff. • Foster a culture of safety, quality, and operational excellence. 4. Safety & Environment • Enforce EHS (Environment, Health & Safety) policies and ensure zero accidents. • Lead risk assessments and incident investigations. • Monitor effluent treatment and hazardous waste management. 5. Process Improvement & Technology Transfer • Collaborate with R&D and Tech Transfer for smooth scale-up and validation. • Support new product introductions (NPI) and technology transfers from R&D or other sites. 6. Budget & Cost Control • Manage manufacturing budgets, OEE (overall equipment effectiveness), and resource planning. • Monitor raw material and solvent usage for cost optimization. • Work with procurement to ensure timely availability of materials. Show more Show less
Job Title: Head of R&D – API Location: Hyderabad, Telangana Department: R&D Reports To: Managing Director Experience Required: 15+ years Education: Ph.D. or M.Sc. in Organic Chemistry Key Responsibilities • Lead and manage R&D activities in API process development , scale-up , and tech transfer to manufacturing. • Drive route scouting , cost-effective synthesis , and process optimization for new and existing APIs. • Spearhead polymorph screening and development for novel and robust API forms. • Oversee patent strategy , including identification, drafting, and filing of process and polymorph patents . • Ensure comprehensive documentation for regulatory filings (DMFs, CMCs) and IP protection . • Collaborate closely with manufacturing, quality, regulatory, and business development teams. • Represent R&D during client meetings, audits, and regulatory inspections. • Cultivate a high-performing, innovation-driven R&D team. Qualifications • Strong expertise in process chemistry , polymorph characterization , and patent filings . • Track record in DMF submissions and regulatory compliance . • Knowledge of crystallography, solid-state chemistry, and intellectual property law is preferred. Strong leadership, project management, and communication skills. Show more Show less
As the Head of Manufacturing API, you will be responsible for overseeing all API production activities at our Atchutapuram, Andhra Pradesh facility. With over 20 years of experience in API manufacturing, you will lead the team to ensure safe, compliant, and efficient manufacturing operations. Your role will involve achieving production targets, maintaining cGMP compliance, and driving continuous improvement across the API manufacturing units. Your key responsibilities will include: Production Management: - Planning and executing API manufacturing based on production schedules. - Ensuring adherence to batch production records (BMRs) and standard operating procedures (SOPs). - Optimizing process yields and reducing production cycle time. - Reviewing and approving production documentation. Compliance & Quality Assurance: - Ensuring full compliance with cGMP, ICH, and regulatory requirements. - Coordinating with QA/QC for timely release and in-process quality checks. - Supporting regulatory inspections and customer audits. - Implementing corrective and preventive actions (CAPAs) and change controls. Team Leadership & Development: - Leading and managing a team of production managers, supervisors, and operators. - Providing training and performance management to manufacturing staff. - Fostering a culture of safety, quality, and operational excellence. Safety & Environment: - Enforcing EHS policies and ensuring zero accidents. - Leading risk assessments and incident investigations. - Monitoring effluent treatment and hazardous waste management. Process Improvement & Technology Transfer: - Collaborating with R&D and Tech Transfer for smooth scale-up and validation. - Supporting new product introductions (NPI) and technology transfers. Budget & Cost Control: - Managing manufacturing budgets, OEE, and resource planning. - Monitoring raw material and solvent usage for cost optimization. - Working with procurement to ensure timely availability of materials. In this role, your leadership, technical expertise, and strategic thinking will be crucial in driving the success of our API manufacturing operations.,