Saikiran Reddy Anumandla
Assistant General Manager @Nayas Laboratories
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WORK HISTORY
Assistant General Manager @Nayas Laboratories
Hyderabad, IN
Lead analytical R&D for 505(b)(2) complex injectables and peptide drug delivery systems Gel based, leveraging QbD, reverse engineering, and advanced characterization (DLS, NTA, Microscopy, Malvern G4, ELISA, HPLC/UPLC, PSD) to accelerate regulatory filings and commercialization.•Led 20+ member cross-functional teams in method development, validation, stability studies, and tech transfers, delivering 25% faster timelines for FDA/EMA-aligned ANDA/NDA submissions.•Oversaw peptide/oligonucleotide formulations and NDDS (nano-delivery, controlled release), achieving 3 scale-ups with bioequivalence and GLP compliance.•Director $7M+ project portfolios using PMP methodologies, ensuring 98% on-time milestones, risk mitigation, and OOS/OOT investigations.•Drove seamless collaboration across R&D, QA, regulatory, and CDMO partners, integrating data analytics for process optimization and ALCOA++ documentation.•Pioneered RS method development for peptides and complex injectables (Microspheres, Suspension), supporting global market entry in competitive generics space.•Proven leader in high-stakes pharma R&D, bridging innovation, compliance, and execution for sustainable growth.
EDUCATION
Kakatiya University
Bachelor of Science (B.Sc.), Chemistry
Acharya Nagarjuna University
Master of Science (MSc), Chemistry
ABOUT SAIKIRAN REDDY ANUMANDLA
Expert scientist – Analytical Research | Complex Injectables & Peptides ANDA & 505B2 Innovation I am a seasoned pharmaceutical professional in CRDMO environment PMP certified with over 16 years of experience leading analytical development for complex injectable products including peptides, microspheres, ophthalmic emulsions and Nano suspensions, novel drug delivery which contains polymers. Currently serving as AGM at Nayas Laboratories, I drive Analytical Laboratory strategies and solutions for global markets (US FDA, EMA, Brazil, Canada), ensuring robust dosage form development, regulatory compliance, and successful product approvals.My expertise spans analytical method development, validation, technology transfer, Stability studies and regulatory filings, with a proven track record of handling FDA queries Pre and Post approval changes and market extension projects. I have strong leadership in CRO management, laboratory operations, and cross-functional collaboration with essential teams to enable innovation and quality outcomes.A recognized Subject Matter Expert (SME) in peptide characterization and complex injectables characterization, I bring deep technical proficiency in Mass spectrometry, CD, Fluorescence spectroscopy, NMR, Scanning electron microscopy, Size Exclusion Chromatography, Rheology, Particle size distribution by zeta and Master sizers, HPLC/UPLC, GC, and Dissolution including USP IV techniques, applying orthogonal methodologies to address peptide degradation pathways and structural elucidation is a day-to-day exercise in my professional journey.Committed to excellence, regulatory rigor, and innovation, my mission is to leverage scientific insight and leadership to deliver value to organizations, accelerate product development, and enhance patient outcomes across global healthcare markets.
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