Moumita Bhattacharya Email & Phone Number

Boston, Ma, Us

Boston, Massachusetts, United States

Greater Boston

CMC Operations•Collaborated with technical operations, research, and program teams and led CMC team to manage IND-enabling activities for an early stage cell therapy program.Cell Therapy Platform Focus: •Directed the cross-functional working group to establish the aseptic process qualification program for the newly commissioned cell therapy facility.•Collaborated with cell process development group to assess different T-cell cryopreservation formulations and use size-based… Show more CMC Operations•Collaborated with technical operations, research, and program teams and led CMC team to manage IND-enabling activities for an early stage cell therapy program.Cell Therapy Platform Focus: •Directed the cross-functional working group to establish the aseptic process qualification program for the newly commissioned cell therapy facility.•Collaborated with cell process development group to assess different T-cell cryopreservation formulations and use size-based technologies to characterize cells post-thaw. Lentiviral Vector Platform Focus: •Collaborated with vector process development group to improve understanding of long-term stability, in-process hold impact, biophysical characterization, and yield improvement during formulation.•Invented a platform formulation and successfully incorporated the process in several GMP manufacturing campaigns. Formulations Group Managing Role •Created and mentored a matrix team of up to four scientists (two PhDs and two MSs) that innovated formulations and applied analytics to improve product understanding. Show less

Boston, Massachusetts, United States

Greater Boston Area

• Designed and executed DP pre-filled syringes formulation and shipping robustness studies and authored the corresponding BLA content.• Led the working team and implemented manufacturing changes for large-scale drug substance (DS) container, freezing/thawing, storage, and shipping processes of a Phase 3 program. • Established the product presentation and formulation lock as DP lead for a Phase 1 peptide-Fc program.• Collaborated with R&D group to integrate developability risk… Show more • Designed and executed DP pre-filled syringes formulation and shipping robustness studies and authored the corresponding BLA content.• Led the working team and implemented manufacturing changes for large-scale drug substance (DS) container, freezing/thawing, storage, and shipping processes of a Phase 3 program. • Established the product presentation and formulation lock as DP lead for a Phase 1 peptide-Fc program.• Collaborated with R&D group to integrate developability risk assessment, potential critical quality attributes (pCQA) identification, and platform screening and analytical approach as pre-formulations lead. Show less

Greater Boston Area

Greater New York City Area

• Spearheaded commercial formulation development of a mAb using quality by design principles (QbD), process robustness evaluation, biophysical characterization, HPLC-based oxidation monitoring, sub-visible particulate analysis, and DP in-use and compatibility assessment. • Core member of analytical development team responsible for biophysical (Circular Dichroism, Differential Scanning Calorimetry/Fluorimetry, dynamic light scattering, and fluorimeter) and sub-visible particle… Show more • Spearheaded commercial formulation development of a mAb using quality by design principles (QbD), process robustness evaluation, biophysical characterization, HPLC-based oxidation monitoring, sub-visible particulate analysis, and DP in-use and compatibility assessment. • Core member of analytical development team responsible for biophysical (Circular Dichroism, Differential Scanning Calorimetry/Fluorimetry, dynamic light scattering, and fluorimeter) and sub-visible particle characterization (Microflow imaging and HIAC), and solution properties (e.g. density, viscosity, osmolality) of proteins. • Responsible for scientific review of IND, NDA, and BLA documents and authoring of IND. Show less

Greater Boston Area

Doctor Of Philosophy (Phd), Chemical Engineering

Dissertation: “Site-specific conformational probes of misfolded proteins” - Designed single domain antibodies that recognize.

Bs, Chemical Engineering