Ability to design andexecute pre-formulation experiments like solubility, pKa, log P, dissolution,intrinsic dissolution, bulk density, flow indices, solid-state assessment, excipientcompatibility etc.
Completely conversant withhands on experience and/or interpreting data from pre-formulation studies ofa compound including physicochemical, bulk, surface and particle properties.
Ability to design andexecute preclinical formulations to support lead ID, lead optimization and clinicalcandidate selection, including but not limited to solution, suspension,powder for constitution, compound filled in capsules and basic tablet ability.
Reasonably conversant withhands on experience and/or interpreting data from solid-state equipment'slike PXRD, MDSC, TG, DVS and other techniques like Polarizing and Hot-stageMicroscopy and other dynamic image analysis techniques, especiallyduring supporting solid form and salt screening.
An additional benefit wouldbe to have operational experience of handling Particle size analyser,HPLC, GC, Dissolution apparatus and Disintegration apparatus.
Ability to collate andscientifically present data & observations and provide scientific inputs indiscussion with internal or external customers.
Proactively maintain theequipment's, facility and supporting systems as per established good labhandling processes, maintain requisite equipment and process SOPs and lean tools.
Follow good documentationpractices and have adequate exposure to record observations in ElectronicLab Notebook (ELN).
Proactive in aligning withnew technologies and approaches to participate in continuous improvementneeds of the business.
He/she should havesufficient knowledge chemical safety, comprehensive risk assessment of drugsubstance and safe handling.
Technical &Functional:
Sound experience of fundamentals ofpre-formulation and approaches used for preclinical formulation development ofcompounds. Basic knowledge on developing clinical formulation would be an addedplus.
Demonstrated capability in having understandingto design and interpret data from PXRD, modulated DSC, TGA, DVS, Microscopy andworking operations of HPLC, GC, FT-IR, NMR, Dissolution, BET and other physicaland physicochemical characterization techniques. Hands-on operating would be anadded plus.
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