Sijumon Kunjachan

WORK HISTORY

EDUCATION

ABOUT SIJUMON KUNJACHAN

Technical Lead and SME with 10+ years of experience in: Pharmaceutical & Product Development, CMC - Formulation and Delivery of biologics incl. mAb, proteins, peptides, RNA, ADC, small molecules and implants - Expert in Delivery Systems: Nanoparticles, lipids (LNPs, Liposomes), emulsions, polyplexes, peptides, polymer conjugates, dendrimers, micelles, microparticles etc- Experienced in BCS/DCS class formulations; Solubility improvements, HLB parameters- Tablets, capsules, gels, enteric, sustained release formulations manufacturing and quality testing - Freeze drying or lyophilization of drugs and biologics, including freeze-dry stability studies - Biophysical/Analytical knowledge in SEC/UPLC/Ion-pair, DLS, MFI, soloVPE, AKTA, FTIR, NMR, DSC, MFI, HIAC, TEM, etc. Preclinical Pharmacology R&D - Preclinical development and understanding of NDA-enabling studies - Experimental methods and protocols - Framing SOPs, IACUC protocols from scratch - Hands-on in vivo animal testing in mice, hamster, monkey (CRO), mini pig models - In-depth knowledge in biopharmaceutics/PK, including compartmental models - AUC, CL, Tmax, Cmax and other PK para and compartmental analysis - Exposure to BSL1, BSL2 and GMP, GLP settings Imaging & Radiation Studies - Research - Proficient in noninvasive imaging modalities - Expert in Optical- FRI, FMT, 3D FMT, Ultrasound, MRI, Photoacoustic, CT- CBCT, microCT, CT-FMT - Radiation studies in small animals/NHP Leadership, Management & Collaboration - Project management, Collaboration, Leadership - Authored technical protocols, reports, publications, INDs and clinical studies - Supervised PhDs/Postdocs/associate level scientists (>25 overall)- Handled CROs, CMO/CDMO, Startups, and academic centers - Collaboration with internal & external stakeholders (QC/QA, program management, Clinical Ops,) team - Assisted submissions per ICH, FDA guidelines and authored IND section filing - Scale up and Tech transfer of methods and protocols