Tech Lead- MSAT API

Purpose of the Role

Lead the end-to-end technical stewardship of peptide products within the dedicated peptide manufacturing block ensuring successful scale-up commercialization technology transfer process robustness lifecycle management yield improvement and sustainable commercial performance. Act as the technical bridge between R&D Manufacturing Quality Regulatory Affairs Supply Chain and Engineering to enable reliable compliant and cost-effective peptide manufacturing.

Key Responsibilities

1. Commercialization & Technology Transfer Leadership

• Lead transfer of peptide processes from R&D to commercial manufacturing ensuring successful scale-up and first-time-right execution.
• Establish scalable manufacturing strategies for SPPS solution-phase synthesis purification by reverse phase chromatography (RPHPLC) isolation and finishing operations like Lyophilization and spray drying.
• Drive technology absorption and process understanding for new peptide products.
• Serve as technical lead for process validation PPQ campaigns and commercialization activities.
• Ensure smooth transfer of process knowledge critical parameters and control strategies from development to manufacturing.
• Lead site-to-site and process transfer activities when required.

2. Lifecycle Management of Commercial Peptide Products

• Own technical stewardship of commercial peptide products throughout their lifecycle.
• Continuously monitor process performance yield recovery productivity and product quality.
• Lead investigations and resolution of process deviations OOS/OOT trends and manufacturing challenges.
• Drive continual improvement programs to improve throughput cycle time quality and manufacturing reliability.
• Lead process optimization initiatives to enhance plant capacity and operational efficiency.
• Establish data-driven process monitoring and lifecycle management practices.

3. Peptide Process Science & Technical Excellence

• Provide deep technical expertise in peptide synthesis technologies including:
  • Solid Phase Peptide Synthesis (SPPS)
  • Solution Phase Peptide Synthesis
  • Cleavage and deprotection processes
  • Purification technologies
  • Chromatographic separation systems
  • Lyophilization and isolation operations
• Drive scientific understanding of process chemistry impurity generation pathways and critical quality attributes.
• Lead troubleshooting of complex synthesis purification and scale-up challenges.
• Develop robust control strategies to consistently achieve yield quality and productivity targets.

4. Manufacturing Excellence & Productivity Improvement

• Drive Cost Improvement Programs (CIPs) through process intensification yield enhancement and cycle time reduction.
• Identify opportunities for debottlenecking and capacity enhancement within the peptide block.
• Improve asset utilization resource productivity and manufacturing efficiency.
• Drive automation digitization and advanced process technologies to enhance operational performance.
• Benchmark peptide manufacturing practices against industry standards and identify improvement opportunities.

5. Process Validation & Regulatory Support

• Lead preparation review and approval of process validation strategies protocols and reports.
• Ensure processes consistently meet regulatory expectations and internal quality requirements.
• Support regulatory submissions customer audits inspections and technical due diligence activities.
• Provide scientific justification for process changes deviations and lifecycle improvements.
• Ensure robust change management and compliance with cGMP requirements.

6. New Technology & Capability Building

• Evaluate and implement emerging peptide manufacturing technologies.
• Drive adoption of innovative synthesis purification and process analytical technologies.
• Build technical capabilities within MSAT and manufacturing teams.
• Establish best practices knowledge management systems and technical standards for peptide manufacturing.
• Collaborate with internal and external experts to strengthen peptide technology capabilities.

7. Cross Functional Technical Leadership

• Act as single point technical owner for commercial peptide products.
• Partner closely with R&D Manufacturing Quality Regulatory Affairs Engineering and Supply Chain teams.
• Align technical priorities with business customer and operational requirements.
• Support capacity planning campaign planning and long-term manufacturing strategy.
• Drive technical decision-making during scale-up commercialization and lifecycle management activities.

Key Deliverables

• Anchor process validation and regulatory compliance.
• Right-first-time technology transfers.
• Successful commercialization of peptide products.
• Sustainable yield and recovery improvements.
• Improved plant productivity and capacity utilization.
• Reduced cycle times and manufacturing costs.
• Reliable commercial supply with minimal process disruptions.
• Strong peptide technology capability within the organization.

Critical Success Measures

Commercialization

• Technology transfer success rate
• Validation batch success rate
• Time-to-commercialization

Manufacturing Performance

• Yield improvement (%)
• Recovery improvement (%)
• Cycle time reduction (%)
• Capacity utilization improvement (%)

Productivity

• Cost Improvement Program (CIP) value realization
• Manufacturing cost reduction
• Throughput improvement

Quality & Compliance

• Reduction in process deviations
• First-pass batch success rate
• Audit and inspection readiness

Technical Excellence

• Number of successful troubleshooting interventions
• New technology implementation milestones
• Technical capability development of team

Qualifications :

Preferred Candidate Profile

Education Background

• PhD / / / . in Chemical Engineering Organic Chemistry Pharmaceutical Sciences or related discipline.

Experience

• 12-18 years in peptides oligonucleotides complex APIs or high-value pharmaceutical manufacturing.
• Proven experience in peptide scale-up commercialization and commercial manufacturing support.
• Strong exposure to SPPS purification technologies and lifecycle management.
• Demonstrated success in technology transfer validation and process optimization.

Technical Expertise

• Peptide synthesis technologies
• Commercial manufacturing support
• Process scale-up and validation
• Lifecycle management
• Process troubleshooting
• Manufacturing excellence
• Regulatory compliance
• Cost and productivity improvement

Additional Information :

About the Department - IPDO

At the core of our R&D prowess is the Integrated Product Development Organisation (IPDO) at
Bachupally Hyderabad India. The expansive campus of IPDO houses several laboratories powered by
a diverse talent pool of scientists from leading institutions around the world. Our product development
efforts drive a portfolio of more than 1000 products enabled by our robust R&D team consisting of
more than 190 doctorates. We integrate our deep science capabilities and cutting-edge technology to
develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven
innovation-focused pharmaceutical company committed to accelerating access to healthcare
solutions globally. We have end-to-end capabilities in API Formulations Clinical Intellectual Property
and Regulatory Affairs. We serve 55 markets including the USA Canada Europe China LATAM
ASEAN and all Emerging Markets with innovative and generic products ranging from APIs Oral
formulations Parenteral (Injectables Ophthalmics) and other dosages.
Future Focus on Pharmaceutical Innovation

Benefits Offered

At Dr. Reddys we actively help to catalyze your career growth and professional development through personalized 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