
Delivery Manager – API (Process R&D)
Job Description
About the Role
As Delivery Manager – API, you will lead the full spectrum of drug development, overseeing the design, development, scale-up, and approval of APIs including complex molecules like peptides, Oligonucleotides and ADC. This role demands deep expertise in Upstream viz. Solid-phase, Liquid and hybrid peptide synthesis and downstream viz. purification and isolation techniques viz. Lyophilization, spray drying, Characterization, and regulatory aspects.
You will collaborate cross-functionally to deliver IP-driven, globally compliant, and commercially viable peptide products — accelerating development timelines while ensuring safety, scalability, and sustainability.
Role expectations:
• API Process Development: Drive the design and optimization of peptide synthesis (SPPS, LPPS, hybrid), conjugation chemistry, Oligonucleotide synthesis, ADCs and downstream purification (HPLC, Ultrafiltration, lyophilization).
• Early-to-Late-stage Development: Lead the molecule’s journey from preclinical stage through clinical scale-up to tech transfer and commercial manufacturing.
• Quality by Design (QbD): Implement QbD principles, risk assessments, and DoE strategies to build robust, reproducible processes.
• CMC Strategy & Regulatory Alignment: Provide strategic input and documentation for DMF, and ANDA submissions in major regulatory markets (US, EU, ROW).
• Analytical Support: Collaborate with analytical development teams to establish validated, peptide-specific analytical methods (purity, identity, aggregation, and stability).
• Scale-up and Technology Transfer: Drive the scale up of the designed process by deploying suitable technology and guide the CFTs for seamless execution
• Peptide-Specific Challenges: Tackle technical complexities like peptide solubility, aggregation, stereoisomerism, sequence-specific stability, and scale-up of long-chain peptides or cyclic analogues.
• Technology Scouting & Innovation: Identify and deploy emerging peptide technologies (microwave-assisted SPPS, flow synthesis, peptide–drug conjugates).
• Lifecycle & Cost Management: Optimize synthetic routes for cost, purity, and process yield across the lifecycle.
• PhD in Organic/Medicinal Chemistry, Peptide Chemistry, or related field
• 15+ years of experience in API development, with significant focus on peptides, Oligonucleotide and ADC development
• Proven expertise in solid-phase synthesis, downstream processing, analytical method development, and scale-up
• Familiarity with GMP manufacturing, global regulatory guidelines (ICH, USFDA, EMA), and CMC dossier preparation
• Demonstrated leadership in cross-functional environments, tech transfer, and regulatory interactions
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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