Jobs at Cadila Pharmaceuticals Limited

Senior Manager role in Biotech (Research & Development) at Cadila Pharmaceuticals Ltd, based in Dholka, India. The role is responsible for drug substance (DS) manufacturing for vaccines, including planning, supervising and performing production activities while ensuring strict cGMP compliance.

• Ensure strict cGMP compliance during the unit operations and for the facilities, documentation, training reports and records during DS manufacturing for Vaccine
• Plan, supervise and perform production activities of Drug Substance
• Maintain manufacturing records to comply with regulatory requirements
• Monitor manufacturing processes and in process results of different unit operations wherever applicable
• Prepare and review documents as per regulatory requirements like MMD, SOPs and other technical documents
• Ensure readiness of facility for internal and external inspections
• Troubleshoot technical issues in consultation with the Production Head during shift duties
• Participate in audits and investigations to recommend solutions and justifications and resolve problems
• Prepare and maintain WCB, MVS and WVS for upstream technicians
• Operate all the equipment required for the upstream process of Drug Substance for upstream technicians
• Operate all the equipment required for the downstream process of Drug Substance for downstream technicians
• Carry out the defined developmental experiments for yield improvements and process scale up
• Provide training to new personnel in a specific technical process
• Carry out in-process analysis during the batch operation wherever applicable
• Perform QMS related activities like change control, deviations, CAPA, incident management, risk management etc.
• Manage the facility and order laboratory supplies for smooth functioning of the facility
• Coordinate with different departments for timely manufacturing of drug substance
• Ensure safe and efficient operation of production equipment following safety procedures in order to protect the safety of themselves and their colleagues
• Efficiently execute the production schedule without deviations
• Schedule and monitor regular maintenance of equipment and facility in coordination with the engineering team
• Act as technical person for review and approval of batch manufacturing records

• Manufacturing Experience: Experience in upstream and/or downstream processing, vaccine manufacturing, and biologics production operations.
• GMP and Regulatory Compliance: Strong understanding of cGMP requirements, regulatory documentation, inspection readiness, and manufacturing compliance.
• Technical Documentation: Experience in preparing and reviewing SOPs, manufacturing documents, technical reports, and Batch Manufacturing Records.
• Process Development: Knowledge of process optimization, yield improvement, developmental experiments, and process scale-up.
• Quality Management Systems: Experience with change control, deviations, CAPA, incident management, risk management, and investigations.