Dr.Reddy's Laboratories offers a competitive total rewards package including base salary determined on the basis of role, experience, skill set and location. Additionally, employees are eligible for an annual discretionary bonus, and benefits including comprehensive health care coverage, retirement savings plan and leave benefits. Additional details about total compensation and benefits will be provided during the hiring process.
Post : Drug Product Team Lead
Job summary
We are looking for a meticulous professional to lead drug product manufacturing and sterile formulation operations, ensuring adherence to Current Good Manufacturing Practice (cGMP) and safety norms. Your focus on drug product validation within defined timelines and volumes, while maintaining compliance with quality standards and regulatory requirements, is crucial to the organization's commitment to excellence in pharmaceutical production.
Roles & Responsibilities
• You will be responsible for receiving inputs from production planning and preparing the monthly operation plan on the production floor, encompassing scheduling, staffing, monitoring, training, and troubleshooting to ensure that all operations comply with applicable BPRs/EBRs (Batch Production Record/Electronic Batch Record), SOP (Standard Operating Procedures), and safety guidelines.
• Your role involves understanding and administrating contract manpower, supporting capacity supply and planning, monitoring and controlling production schedules, and preparing the annual production budget.
• You will be responsible for reviewing and approving SOPs, protocols, reports, discrepancies, change requests, CAPA (Corrective and Preventive Actions), QRM (Quality Risk Management), and batch and packaging records.
• Your role will include collaborating with cross-functional departments to close discrepancies and implement corrective actions, ensuring compliance with relevant GMP (Good Manufacturing Practices), safety standards, and SOPs for designated manufacturing equipment.
• Your role includes completing batch documentation in compliance with GMP, collecting and maintaining data, and participating/leading in quality and safety investigations to address and improve CAPA for drug product manufacturing & sterile formulation operation.
• You will be responsible for maintaining manufacturing equipment for functionality and calibration compliance, operating manufacturing equipment and automated systems within validated process parameters, and actively promoting safety awareness and improvements.
• You will engage in continuous improvement activities, adhere to safety rules, and report any unsafe matters or near misses/accidents.
• You will be responsible for goal setting and performance reviews, training, and coaching employees, effectively managing employee performance issues and corrective actions, recognizing and appreciating employee contributions, and undertaking activities to support the achievement of individual, departmental, and business objectives.
Candidate Profile
Educational qualification: B.Pharma., M.Pharma., M.Sc.
Minimum work experience: 8 to 10 years of experience in working with Biosimilar Products & sterile formulation operation.
Technical Skills
• Solid understanding of process manufacturing, sterile formulation, quality systems, and the regulatory environment within the pharmaceutical or biopharmaceutical industry.
• Expertise in cGMP principles and a strong knowledge of safety standards, ensuring compliance with industry regulations.
• Knowledge of biologics manufacturing processes, emphasizing familiarity with the unique considerations and requirements of producing biosimilar products.
• Expertise in formulation operations and sterile manufacturing, showcasing knowledge of the specialized processes and stringent requirements in these areas.
Behavioural skills
• Good listening and interpersonal skills, fostering effective communication and collaboration within teams.
• A keen eye for detail, ensuring accuracy and precision in tasks and deliverables.
• Sensitivity to deadlines, managing time effectively to meet project timelines.
• Ability to analyse situations and troubleshoot issues, contributing to efficient problem-solving within the team.
Additional Information
Experience : 8 to 10 years
Qualification : B.Pharma., M.Pharma., M.Sc
Location : Hyderabad, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Drug Product
End Date : 30th October 2026
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