Job Title: MSAT Specialist – Technology Transfer (Parenteral)
Location: Pydibimavaram IPDO
Company: Dr. Reddy’s Laboratories Ltd
Job Summary:
* Role: MSAT Specialist focusing on Technology Transfer for Parenteral products.
* Primary Focus: Managing the full product lifecycle, from initial technology transfer to commercial manufacturing.
* Technical Expertise: Specialization in injectable/sterile product manufacturing processes.
* Core Responsibilities: Protocol development, process validation, risk assessment, and regulatory compliance.
* Collaboration: Partnering with cross-functional teams to ensure seamless site transfers and process improvements.
Company Overview:
Dr. Reddy’s Laboratories is a global pharmaceutical company committed to providing access to affordable and innovative medicines. We are driven by a purpose to accelerate access to healthcare solutions for patients worldwide. At our Integrated Product Development Organization (IPDO) in Pydibimavaram, we push the boundaries of science and engineering to deliver high-quality pharmaceutical products. We are currently seeking a dedicated and detail-oriented MSAT (Manufacturing Science and Technology) Specialist to join our Parenteral team and play a critical role in our product development and transfer lifecycle.
Role Purpose:
As an MSAT Specialist, you will be the technical bridge between research and development and commercial manufacturing. Your primary responsibility will be to ensure the robust, compliant, and efficient transfer of sterile injectable products. You will handle everything from initial scale-up and process validation to the ongoing monitoring of commercial batches. You will ensure that our manufacturing processes are optimized for quality, safety, and regulatory alignment.
Key Responsibilities:
Technical Documentation and Lifecycle Management
You will be responsible for the preparation, review, and approval of comprehensive technical protocols, reports, and product impact assessments. This includes managing the documentation necessary for product lifecycle management (LCM) to ensure that every stage of production is meticulously recorded and analyzed for continuous improvement.
Technology Transfer and Scale-up
You will lead and support the technology transfer of new products, line transfers, and site-to-site commercial transitions. This requires a proactive approach to risk mitigation and the ability to coordinate with cross-functional teams to ensure that scaling up processes for injectable products is executed smoothly without compromising product quality.
Process Improvement and Troubleshooting
A core part of this role involves investigating non-conformances, such as incidents, Out of Specification (OOS) results, Out of Trend (OOT) data, and market complaints. You will perform root cause analysis (RCA) to resolve these issues and implement corrective actions. Furthermore, you will conduct data analysis to identify trends, recommend manufacturing process improvements, and assist in the integration of new, more efficient technologies.
Compliance and Regulatory Support
You will ensure that all operations strictly adhere to Good Manufacturing Practices (GMP). This includes the preparation and review of cleaning validation documents, process master plans, and Continuous Process Verification (CPV) schedules. You will play a vital role in supporting regulatory filings and preparing the team for rigorous regulatory audits, ensuring that our products meet the high standards required for global market approval.
Cross-Functional Coordination
Success in this role depends on your ability to work collaboratively. You will act as a central point of contact for manufacturing, quality assurance, regulatory affairs, and development teams. By fostering clear communication and shared objectives, you will help address regulatory deficiencies and ensure that product approvals remain on schedule.
Qualifications and Skills:
To be successful in this role, candidates must meet the following educational requirements:
* Bachelor of Technology or Bachelor of Engineering (Chemical Engineering)
* Bachelor of Pharmacy (B.Pharm)
* Master of Pharmacy (M.Pharm)
Required Competencies:
* Strong understanding of sterile manufacturing environments and parenteral product technology.
* Proficiency in technical writing, protocol development, and report generation within a GMP-regulated environment.
* Proven experience in performing risk assessments, root cause analysis, and implementing preventative and corrective actions.
* Excellent data analysis skills with an ability to interpret trends and suggest data-driven process improvements.
* Strong project management abilities to handle multiple product transfers simultaneously.
* Ability to work under pressure while maintaining the highest standards of accuracy and regulatory compliance.
Why Join Dr. Reddy’s?
At Dr. Reddy’s, we value innovation, integrity, and a passion for excellence. Joining our Pydibimavaram IPDO team means working in a fast-paced, high-impact environment where your technical expertise directly contributes to delivering life-saving medicines to patients. We offer a culture that fosters professional growth, encourages technical brilliance, and supports you in making a real difference in the pharmaceutical industry.
Application Process:
If you are a motivated professional with a background in chemical engineering or pharmacy and have a keen interest in sterile technology transfer, we invite you to apply. Please visit the official Dr. Reddy’s Careers portal to submit your application and view further details regarding the position. We look forward to reviewing your application and potentially welcoming you to our team.