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2.0 - 14.0 years
0 Lacs
karnataka
On-site
As a candidate for the position, you should possess a M. Pharm (Pharmacology/ Pharmaceutical Analysis) or M.Sc. (Biochemistry/ Pharmaceutical Chemistry) degree with 11-14 years of experience or a Ph.D. with 2-5 years of experience in the fields of large molecule/ADC PK and bioanalysis. Your expertise should include Antibody Drug Conjugate characterization and bioanalysis, mass spectrometry-HRMS, Q-TOF, and Triple quad. Your role will involve being an expert in designing and executing DMPK studies to support antibody-drug conjugate (ADC) and monoclonal antibody (mAb) programs, ranging from discovery to IND-enabling stages. You should have extensive experience in quantifying biologics such as antibodies, therapeutic proteins, ADCs, and peptides using LC-MS/MS, MSD, and ELISA platforms. Proficiency in advanced bioinformatics tools like BioPharma Finder, MaxQuant, Spectronaut, and other relevant analytical software is essential. Your responsibilities will also include applying innovative techniques for identifying and selecting ADC and mAb lead candidates based on their functions, with a strong emphasis on DMPK profiling to ensure the safe and effective development of therapeutics. You should be adept at interpreting complex DMPK data and providing actionable insights to cross-functional project teams. Active representation of DMPK functions in internal and external meetings to promote collaboration and strategic alignment is crucial. Collaboration with cross-functional departments to address ADC-related challenges and provide integrated solutions from target validation to IND submission will be part of your role. You will be accountable for authoring and reviewing SOPs, study protocols, reports, and regulatory documentation to support both GLP and non-GLP studies. A strong foundational knowledge of DMPK principles including PK/PD, toxicology, and translational sciences is required. Demonstrated capabilities in communication, innovation, and team leadership will be essential for success in this position.,
Posted 2 days ago
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