Sandeep Zode
Angestellt, Scientist, Formulations (CMC), Ferring Pharmaceuticals
Hyderabad, Telangana, India, Indien
Über mich
An independent, innovative and result driven Pharmaceutical Scientist with 10+ (4+6) years of academic-cum-industrial experience in drug product design and process development of conventional and enabling dosage forms while working in multi-disciplinary environment. Driving product from early stage to late-stage development with sound understanding on regulatory requirements and intellectual property. Demonstrated ability to influence cross-functional teams by leveraging presentation and communication skills.
Werdegang
Berufserfahrung von Sandeep Zode
Bis heute 3 Jahre und 4 Monate, seit Feb. 2021
Scientist, Formulations (CMC)
Ferring Pharmaceuticals
Leading product design and monitoring product performance from early-stage to late-stage development for sterile liquid/gels for intravesical and lyophilized granules for oral drug delivery. Decision maker for selection of drug delivery, identification of stagewise risks and mitigation strategies. Implementation and successful establishment of new processes for product scale-up.
Led design and development of sterile liquid and lyophilized formulations of anticancer drugs for the regulated market. Successfully transferred the two lyophilized products (solution and suspension) from lab scale to manufacturing scale for the regulated market. Used QbD principles while designing and scaling up the aforementioned formulations to obtain robust product. Mentored research project for junior team members. Successfully implemented controlled ice nucleation technology in lab scale lyophilizer.
Worked on development of 505b2 formulations for regulated market. Designed and established proof-of-concepts for three drug molecules (nasal solution and injectable suspension and emulsions) in the animal model. The projects have been successfully translated to patented formulations. Fortunate to contribute as a team member for the formulation TosymraTM (sumatriptan) nasal spray, a differentiated formulation approved under 505b2 filing by USFDA, Jan 2018.
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Englisch
Fließend
Hindi
Fließend
Marathi
Muttersprache
Deutsch
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