Varsha Mahankar

Cell culture and bioprocess professional with 2+ years of hands-on experience in GMP-compliant environments. Skilled in mammalian cell culture, including suspension and adherent cell culture systems, aseptic processing, and media preparation. Experienced in cell isolation, expansion, maintenance, and regulated laboratory workflows.

Proficient in documentation, quality compliance, and cross-functional collaboration. Seeking opportunities in cell culture, bioprocessing, and biopharmaceutical manufacturing.

Associate Scientist – CAR-T Cell Manufacturing - ImmunoACT Pvt. Ltd. - Navi Mumbai

(2024-02)

• Executed end-to-end mammalian cell culture operations in GMP-grade cleanroom environments (Grade A, B, and C), ensuring compliance with batch records and regulatory standards.
• Performed cell isolation, activation, expansion, and harvesting of mammalian cells under aseptic conditions.
• Managed downstream handling including cryopreservation, controlled-rate freezing, and storage of cell-based products.
• Contributed to R&D, developed Anti-CD20 CAR-T manufacturing process and designed an automated media aliquoting system using a peristaltic pump, reducing manual time.
• Authored GMP quality documents: SOPs, Process Validation Protocols, Change Controls, Risk Assessments, Impact Assessments, and Technology Transfer documents.
• Ensured compliance with GMP, GLP, GDP, and regulatory quality standards.
• Collaborated cross-functionally with QA, QC, and R&D teams to streamline manufacturing operations and documentation workflows.

Research Associate – Quality Control - StemRx BioScience Solutions - Navi Mumbai

(2023-03 - 2023-10)

• Performed mammalian cell isolation and culture from biological samples, including maintenance of adherent and suspension cultures.
• Drafted quality documents such as BMR, SOP and protocols.
• Contributed to R&D, developed decellularized extra cellular matrix from animal tissues.

Master of Science - Applied Genetics - Indian Academy Degree College (2020 - 2022)

Bachelor of Science - Zoology - K.J. Somaiya College of Science & Commerce (2017 - 2020)