Devrishi Goswami Email & Phone Number

San Diego, Ca, Us

Foster City, Ca, Us

- DP team lead for multiple programs; experienced in leading technical teams responsible for early and late-stage DP formulation (FIH/Pivotal formulation lock) and process development, tech transfer to clinical/commercial sites, manufacturing, and regulatory filing. - Proactively initiated and implemented CMC strategies: carried out gap analyses, risk assessment, and drive improvement actions to meet projected clinical demands.- CDMO management: partnered and collaborated with major CDMOs for implementing DP work strategies. Reviewed/approved documentation (batch records, specs, technical reports), PIP support.- Recruited and led high-performance team. Managed performance for directs reports and coached for career development.

Thousand Oaks, Ca, Us

LEADERSHIP SKILLS:- Drug product team lead (CMC) for early phase programs; led advancement of multiple programs across various modalities from molecular assessment to Ph1 clinical trial# Single point DP accountability # Led cross functional CMC team# Strategies FIH/Ph1 development and DP manufacturing for continued clinical supply - PDM lead for two early stage programs; responsible for coordinating DS/AS/DP activities for successful transition from research to process development- Led a team of scientists, managed performance and development.TECHNICAL SKILLS:- Formulation development.- Drug product manufacturing process development- tech transfer- NPI- Molecular assessment of critical attributes for selection of the suitable candidate and advancing pipeline in technical development space.- Improving stability and preventing aggregation/degradation of therapeutic proteins (mAbs, bi- specifics, fusion proteins and other novel modalities) using various biophysical and structural mass spectrometry techniques.IP/PATENTS:(1) Method of optimizing a filling recipe for a drug container WO2022246055A1 · Filed May 19, 2022(2) Pharmaceutical composition comprising bispecific antibody constructs for improved storage and administration US20190151448A1 · Filed May 7, 2018

-Worked on a Pfizer sponsored project; characterizing conformational stability of an important therapeutic target and its structural/functional modulation by small molecule modulators (Structure, 2013).

La Jolla, California, Us

Spearheaded new method development/characterized conformational stability of mAbs, large protein complexes and protein-drug interactions using structural mass spectrometry and other biophysical techniques.(Analytical Chemistry 2015; Cell 2014; Angew Chem. 2014; Structure 2014; JBC 2014; JASMS, 2013; PNAS 2013; JBC 2013; JBC 2012)

Frankfurt, De

-Biophysical characterization of therapeutic membrane proteins. Gained extensive expertise in protein purification techniques, biochemical characterizations (Transport assays, ITC, DSC), structural studies (X ray crystallography, 2D crystals and Electron microscopy). -Identified substrates and characterized binding mechanism of medically important metal transporter from CDF family.-Crystallization, construct optimization of membrane proteins in a structural genomics set up.-Developed cell free expression of cytotoxic transporter proteins which are difficult to express in cell.

Doctor Of Philosophy (Phd), Biochemsitry; Structural Biology And Biophysics

Master Of Science (Ms), Biotechnology

Financial Modeling And Valuation Training Program