Summary
Overview
Work History
Education
Skills
Timeline
Generic

Payal Gala

Newark

Summary

Biotechnology professional with 8+ years of experience in biologics, vaccines, and CAR-T cell therapies. Expertise in drug product and process development from pre-IND to commercialization, focusing on CMC strategies. Key contributor to the clinical development and FDA approval of Vimkunya, leading formulation and process development during Phase 2/3 trials. Proven skills in GMP/GLP environments, regulatory submissions, and project management, with ongoing PMP certification.

Overview

12
12
years of professional experience

Work History

Manager, Drug Product and Formulation

Pheast Therapeutics
Palo Alto
04.2024 - 11.2024
  • Led and supported the successful execution of Phase 1 IND-enabling activities over an 11-month timeline, spanning cell line development through IND submission
  • Directed formulation development, drug product process development, and GMP manufacturing for a lead monoclonal antibody candidate at CDMO sites
  • Oversaw technology transfer and process scale-up activities; provided hands-on technical guidance during GMP drug product manufacturing runs
  • Partnered with Quality to resolve manufacturing deviations and troubleshoot technical issues in real time
  • Reviewed and approved key documents including batch records, stability protocols, SOPs, and regulatory submissions
  • Interpreted and analyzed stability data to inform formulation strategy and support development decisions
  • Designed and executed clinical in-use studies to enable Phase 1 clinical trials
  • Authored and reviewed CMC sections for regulatory submissions, contributing to the IND dossier
  • Managed project timelines, risk registers, and budgeting exercises for labeling and packaging activities; supported vendor identification and selection
  • Utilized a range of project and collaboration tools-including Smartsheet, Microsoft Project, SharePoint, Excel, and PowerPoint-to track milestones, manage documentation, and ensure timely delivery of cross-functional project objectives

Sr. Scientist, Process and Product Development

Allogene Therapeutics
South San Francisco
06.2022 - 03.2024
  • Led and supported late-stage drug product and CMC development activities for CAR-T cell therapies, contributing to clinical advancement and commercialization readiness
  • Developed and implemented technical strategies for aseptic fill/finish processes to support AlloCAR T clinical development programs
  • Designed and executed formulation and drug product process development studies with an emphasis on process robustness, product quality, and molecule stability under manufacturing stress conditions
  • Applied DOE, FMEA, and scale-down modeling approaches to optimize drug product unit operations-including formulation, mixing, filtration, and aseptic filling-enabling efficient process characterization and scale-up
  • Proficient in data analysis and visualization tools including JMP, Spotfire, and Tableau to support data-driven decision-making
  • Provided technical leadership during drug product tech transfers; served as person-in-plant during GMP fill/finish operations
  • Supported manufacturing operations through process capability evaluations, troubleshooting, root cause investigations, and product impact assessments for deviations and process improvements
  • Designed and led clinical in-use studies to support Phase I/II clinical trials, ensuring suitability of product handling and administration
  • Played a key role in deviation investigations and CAPA development to drive timely closure of Change Controls and ensure continuous improvement
  • Authored and reviewed technical protocols, reports, impact assessments, and regulatory documents; supported responses to CMC queries from global health authorities
  • Managed clinical program timelines, risk tracking, and deliverables using MS Project and Smartsheet; maintained integrated project plans and monitored critical path activities
  • Acted as central coordinator across CMC stakeholders-scheduling governance meetings, developing agendas, capturing meeting minutes, and archiving project communications and documentation
  • Demonstrated exceptional organizational and prioritization skills to ensure high-quality execution within aggressive timelines
  • Presented scientific and technical findings at internal CMC meetings and to cross-functional stakeholders, contributing to data-driven strategic decisions

Associate Scientist/Scientist

Nektar Therapeutics
San Francisco
01.2020 - 06.2022
  • Led formulation screening and optimization studies for both liquid and lyophilized biologic drug products, supporting clinical trials from Phase I through III for PEG-protein therapeutics
  • Developed and optimized analytical methods to characterize drug substances and products in compliance with USP/EU pharmacopeia standards
  • Designed and conducted stability studies, including short-term, long-term, and forced degradation studies, to ensure clinical product stability
  • Performed a range of analytical techniques, such as pH, osmolality, sub-visible particulate matter analysis, SE-HPLC, RP-HPLC, IEX-HPLC, and concentration determination by SoloVPE, to evaluate drug substance and product stability
  • Executed clinical in-use studies for Phase I through III trials, supporting the BLA process and clinical development
  • Contributed to GMP drug product process transfers and manufacturing activities at CDMOs, ensuring thorough review of batch records and investigations
  • Designed and led compatibility and comparability studies for drug products manufactured through various processes and development phases
  • Led CapEx submissions for equipment procurement, collaborating with finance teams to ensure timely responses
  • Presented scientific data to senior management, conveying complex information clearly and effectively.
  • Assisted in report writing and contributed documentation for regulatory submissions, including Certificates of Analysis (CoA) and specifications
  • Trained full-time employees (FTEs) on analytical methods and equipment handling, enhancing team capabilities
  • Supported compliance reviews and data verification for BLA and other regulatory documents, ensuring adherence to standards
  • Participated in deviation investigations and CAPA implementation, ensuring timely and appropriate resolution of deviations, CAPAs, and change controls

Sr. Research Associate/Principal Associate

PaxVax Inc. (Acquired by Emergent BioSolutions)
San Diego
05.2016 - 01.2020
  • Provided comprehensive analytical support for vaccine products in both liquid and powder formulations from preclinical through Phase III and into commercialization
  • Performed a range of physicochemical assays including turbidity, intrinsic fluorescence, dynamic light scattering (DLS), zeta potential analysis, and differential scanning calorimetry (DSC) to support formulation screening and characterization
  • Designed and optimized bioassays for Phase II/III programs and supported technology transfer to the Analytical group per ICH guidelines
  • Developed and executed lyophilization processes for vaccine products, including identification of novel excipients and technologies to improve product stability
  • Characterized and optimized drug product manufacturing processes, including fill/finish development for biologics and injectable vaccines; supported container closure system selection (vials/syringes), and scale-up from bench to GMP manufacturing for Phase III and commercial launch
  • Conducted long-term and accelerated stability studies utilizing methods such as micro-BCA for protein concentration, potency assays (Octet, Gyros), purity by SDS-PAGE, particle size by DLS, and concentration by HPLC
  • Operated within GMP and GLP environments, executing quality control testing per SOPs and maintaining working knowledge of FDA, EMA, and ICH regulatory expectations
  • Contributed to the drafting and revision of SOPs, worksheets, technical reports, and batch records, and provided communication support with CMOs
  • Supported authoring of technical development reports and pharmacy manuals for IND submissions
  • Trained and supervised Research Associates and Senior Research Associates, providing data review, experimental oversight, and project direction
  • Played a key role in integration activities during the acquisition of PaxVax by Emergent BioSolutions

Research Associate

Predictive Biology
Carlsbad
10.2015 - 04.2016
  • Maintained and cultured ~1000 mouse embryonic stem cell lines and differentiated them into progenitor cells using automated liquid handling systems.
  • Conducted high-throughput in vitro genetic screening to assess gene function, along with various cellular and molecular biology assays.
  • Authored SOPs, managed data entry (manual and electronic), maintained lab inventory, and ensured organized laboratory operations.

CIRM Research Intern

Sanford Burnham Prebys Medical Discovery Institute
San Diego
10.2014 - 09.2015
  • Conducted research on selective embryonic toxicity and GBM cancer stem cell resistance under postdoctoral supervision
  • Cultured and differentiated human embryonic stem cells (H9) into dorsal/ventral neural progenitor cells and neurons; developed and optimized differentiation protocols
  • Performed molecular biology assays including RNA extraction, cDNA synthesis, qPCR, ICC, FACS, and live imaging-based high-content screening
  • Treated cells with candidate compounds; assessed growth and differentiation responses to identify toxicity and therapeutic potential

Relationship Executive

Cryobanks International India Pvt. Ltd
Mumbai
12.2012 - 04.2013
  • Built and maintained strong relationships with OB-GYNs to support lead generation and client onboarding
  • Delivered presentations to expecting couples, converting leads into sales by effectively communicating service benefits
  • Coordinated between hospitals, doctors, and clients to ensure seamless information flow and timely record sharing before and after delivery
  • Managed client registrations, payment collection, and documentation; supported customer care with dispatch of necessary documents to clients and HQ.
  • Maintained accurate daily reports and ensured timely submissions

Education

Master of Science - Biotechnology

California State University Channel Islands
Camarillo, CA
09.2015

B. Tech - Biotechnology

Padmashree Dr. D. Y. Patil University
Mumbai, India
06.2012

Skills

  • Drug product development
  • Process development
  • Formulation development
  • Design of experiment
  • Technology transfer
  • MSAT
  • GMP manufacturing
  • Aseptic fill/finish for different DP configurations
  • Clinical in-use studies
  • Stability studies
  • Regulatory support
  • Authoring Module 3 sections
  • CDMO management
  • Project management
  • Smartsheet and MS Office tools
  • Data analysis
  • Technical writing
  • Risk management
  • Problem solving
  • Cross-functional collaboration

Timeline

Manager, Drug Product and Formulation

Pheast Therapeutics
04.2024 - 11.2024

Sr. Scientist, Process and Product Development

Allogene Therapeutics
06.2022 - 03.2024

Associate Scientist/Scientist

Nektar Therapeutics
01.2020 - 06.2022

Sr. Research Associate/Principal Associate

PaxVax Inc. (Acquired by Emergent BioSolutions)
05.2016 - 01.2020

Research Associate

Predictive Biology
10.2015 - 04.2016

CIRM Research Intern

Sanford Burnham Prebys Medical Discovery Institute
10.2014 - 09.2015

Relationship Executive

Cryobanks International India Pvt. Ltd
12.2012 - 04.2013

Master of Science - Biotechnology

California State University Channel Islands

B. Tech - Biotechnology

Padmashree Dr. D. Y. Patil University

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