Ability to design and execute pre-formulation experiments like solubility, pKa, log P, dissolution, intrinsic dissolution, bulk density, flow indices, solid-state assessment, excipient compatibility etc.
Completely conversant with hands on experience and/or interpreting data from pre-formulation studies of a compound including physicochemical, bulk, surface and particle properties.
Ability to design and execute preclinical formulations to support lead ID, lead optimization and clinical candidate selection, including but not limited to solution, suspension, powder for constitution, compound filled in capsules and basic tablet ability.
Reasonably conversant with hands on experience and/or interpreting data from solid-state equipment's like PXRD, MDSC, TG, DVS and other techniques like Polarizing and Hot-stage Microscopy and other dynamic image analysis techniques, especially during supporting solid form and salt screening.
An additional benefit would be to have operational experience of handling Particle size analyser, HPLC, GC, Dissolution apparatus and Disintegration apparatus.
Ability to collate and scientifically present data & observations and provide scientific inputs in discussion with internal or external customers.
Proactively maintain the equipment's, facility and supporting systems as per established good lab handling processes, maintain requisite equipment and process SOPs and lean tools.
Follow good documentation practices and have adequate exposure to record observations in Electronic Lab Notebook (ELN).
Proactive in aligning with new technologies and approaches to participate in continuous improvement needs of the business.
He/she should have sufficient knowledge chemical safety, comprehensive risk assessment of drug substance and safe handling.
Technical & Functional:
Sound experience of fundamentals of pre-formulation and approaches used for preclinical formulation development of compounds. Basic knowledge on developing clinical formulation would be an added plus.
Demonstrated capability in having understanding to design and interpret data from PXRD, modulated DSC, TGA, DVS, Microscopy and working operations of HPLC, GC, FT-IR, NMR, Dissolution, BET and other physical and physicochemical characterization techniques. Hands-on operating would be an added plus.
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