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.

Qualifications :

Qualification and Experience:

- / / / / Bachelors or Masters degree in Pharmacy Chemical Engineering Biotechnology or related discipline.
- 12-18 years of experience in sterile injectables manufacturing preferably in regulated pharmaceutical environment.

Additional Information :

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys 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 1150 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.

Perks Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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 Work :

No

Employment Type :

Full-time

📌 Production Head (Visakhapatnam)
🏢 Dr. Reddy's Laboratories
📍 Visakhapatnam