We are looking for MSAT team member who will serve as the technical bridge between process development and commercial production. Operating within a cGMP environment, this role provides end-to-end technical oversight, process engineering expertise, and scientific support to ensure the robust, scalable, and safe manufacture of Active Pharmaceutical Ingredients (APIs). The successful candidate will drive technology transfers, lead complex root-cause investigations, and champion continuous process improvement (CPI) to optimize product yield and quality.
Responsibilities:
1. Technology Transfer & Scale-Up
- Support the technical transfer of new API / Intermediate chemical synthesis processes from MSAT lab or external customers into commercial-scale manufacturing.
- Conduct laboratory experiments for feasibility studies and / or continuous improvement purpose.
- Perform facility-fit assessments, chemical engineering calculations (e.g., mass/energy balances, heat transfer, mixing dynamics), and scale-up modeling.
- Draft, review, and execute Technology Transfer Protocols, Campaign Summary Reports, and regular technical risk assessments (FMEA).
- Support to the EHS department in analysis the process safety data and interpretation.
2. Process Validation & Monitoring
- Support to the Validation program Process / clean protocols and Continued Process Verification (CPV) plans in alignment with ICH guidelines and Quality compliance requirements.
- Provide real-time shop floor technical support during active manufacturing campaigns and validation batches.
3. Deviation, Investigation & CAPA Management
- Act as the Technical Subject Matter Expert (SME) for manufacturing deviations, batch failures, and out-of-specification (OOS) results.
- Utilize structured root-cause analysis (RCA) tools (e.g., Fishbone, 5 Whys) to determine technical root causes and implement robust Corrective and Preventive Actions (CAPAs).
4. Continuous Improvement & Lifecycle Management
- Identify and implement process optimization initiatives to enhance yield, minimize impurity profiles, reduce solvent consumption, and cut cycle times.
- Manage technical aspects of lifecycle changes, authoring technical justifications for change controls.
5. Regulatory & Compliance Support
- Support the technical queries for regulatory filing queries.
- Participate as a technical SME during regulatory inspections and client audits.
Education:
Bachelor’s, Master’s, or Ph.D. in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a closely related technical discipline
Experience:
Minimum 5 Years of experience in pharmaceutical industry.
Benefits
We offer competitive salary and comprehensive benefits like
- Defined contribution pension scheme
- Life assurance
- Private health insurance for self and family
- Sickness Absence
- Income Protection Scheme
- Travel Insurance- Business and Personal
- Sports and Health club membership fee reimbursement
- Cycle to work scheme
- Enhanced Maternity / Paternity leave
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.