About this opportunity
Responsible for leading end-to-end manufacturing operations in FTO-9 Production predominantly focusing on Complex Injectables pertaining to Octreotide, Microspheres etc ensuring safe, compliant, and efficient execution of sterile manufacturing activities.
The incumbent will drive Complex Injectable Manufacturing - including new product introductions, technology transfer, commercial-scale production, sterility assurance, and continuous improvement initiatives while ensuring adherence to cGMP, quality, safety, and regulatory requirements.
Key Responsibilities
Production Operations
Lead and manage manufacturing and filling operations in FTO-9 Production.
Ensure availability of manpower, machinery, materials, and utilities to achieve production targets.
Drive execution of monthly production plans and ensure timely delivery as per business requirements.
Monitor and improve productivity, yield, capacity utilization, and operational excellence across manufacturing processes.
Oversee compounding operations, water systems, and associated production activities.
New Product Introduction & Technology Transfer
Lead New Product Introduction (NPI) activities and manufacturing readiness initiatives.
Manage technology transfer projects from R&D and external sites to commercial manufacturing.
Coordinate cross-functional activities for process validation, equipment qualification, and successful product commercialization.
Ensure seamless scale-up and transfer of complex injectable products.
Sterile Manufacturing & Compliance
Ensure compliance with aseptic practices and sterile manufacturing requirements in Grade-C and controlled environments.
Participate and provide leadership in media fills, sterilization activities, Isolator VHP qualifications, and sterility assurance programs.
Ensure adherence to cGMP, data integrity, and regulatory requirements.
Review and approve GMP documents including SOPs, BMRs, URS, protocols, reports, and related quality documentation.
Quality & Investigation Management
Review and approve investigations, deviations, OOS, incidents, CAPAs, and change controls.
Coordinate with QA, QC, Engineering, Warehouse, SHE, Administration, F&D, and TTG for issue resolution and compliance activities.
Ensure product quality and batch yield remain within specified limits.
Support audit readiness and regulatory inspection preparedness.
Engineering & Project Management
Coordinate with Engineering teams for equipment reliability, maintenance, and operational excellence.
Review and approve Purchase Requisitions, CAPEX proposals, and project requirements.
Participate in facility expansion, equipment qualification, automation, and process improvement initiatives.
Conduct regular Gemba walks and shop-floor reviews to drive continuous improvement.
Training & Team Development
Act as a qualified trainer and impart technical and GMP training to manufacturing personnel.
Ensure timely completion of LMS trainings and competency assessments.
Build a high-performance team culture focused on safety, quality, compliance, and productivity.
Audits & Regulatory Compliance
Participate in internal, customer, and regulatory audits.
Lead audit response preparation and implementation of corrective and preventive actions.
Ensure closure of observations within agreed timelines.
Key skills required:
Proven experience in sterile injectable manufacturing operations.
Strong exposure to Microspheres manufacturing and associated aseptic processing operations.
Hands-on experience in Complex Injectable Manufacturing, including technology transfer and commercial-scale production.
Experience in handling SKID systems, process equipment integration, and utility coordination.
Exposure to compounding, filling, sterilization, water systems, and isolator-based manufacturing.
Strong understanding of cGMP, regulatory compliance, investigation management, and sterility assurance programs.
Experience in new product introduction, validation, qualification, and process optimization.
Qualification and Experience:
B.Pharm / M.Pharm / B.Tech / M.Tech / Bachelor's or Master's degree in Pharmacy, Chemical Engineering, Biotechnology, or related discipline.
12-18+ years of experience in sterile injectables manufacturing, preferably in regulated pharmaceutical environment.
About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future.
Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/
Job details
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Salary context
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Seniority mix
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