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

Preferred Candidate Profile

Education Background

PhD / M.Tech / M.Pharm / M.Sc. 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

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 1,000 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. Reddy's, we actively help to catalyze your career growth and professional development through personalized 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/#!/ .

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