Technical Stewardship Lead - Peptide Manufacturing

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

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

• 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

• 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 1,000 products, enabled by our robust R&D team consisting of more than 19