Tech Lead- MSAT API
- Full-time
- Job Family: Engineering & Science
- Sub Job Family: Process Engineering - API
- Preferred type of working: On-Premise
- Years of Experience: 12 - 20
- Business unit: IPDO
Company Description
Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).
‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency
Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.
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Job Description
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 / 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 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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