Delivery Manager – API (Process R&D)

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