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
