Ashutosh Pandey
Buxar
Summary
Bioprocess specialist with 6+ years of experience in upstream process development, technology transfer, and GMP manufacturing of monoclonal antibodies and viral vaccines. Proven expertise in scaling bioprocesses from lab to commercial scale, facility setup, and cross-functional project leadership. Adept in handling CHO, HEK293, and microbial systems with strong documentation and compliance skills.
Overview
6
6
years of professional experience
Work History
Associate Manager – Upstream & Facility Setup
Medtherapy Biotech
05.2025 - Current
- Leading upstream process development and facility setup for CAR-T and viral vector manufacturing.
- Overseeing layout finalization, safety evaluations, utility planning, and C&Q activities.
- Managing lab instrumentation for upstream, downstream, and analytical workflows.
- Utilizing eVAL, DocuSign, and SAP for qualification documentation and digital workflows.
Scientist – Upstream R&D
Aurigene Pharmaceutical Services Ltd.
12.2023 - 04.2025
- Spearheaded upstream operations for biosimilar development in a CDMO setting.
- Led CapEx/OpEx budgeting, lab setup, and project execution across cross-functional teams.
- Directed qualification activities and vendor coordination to meet aggressive timelines.
- Supported process development, technology transfer and scale-up for mammalian cell culture processes.
Senior Research Associate – MSAT Upstream
Zydus Research Centre
11.2022 - 11.2023
- Executed tech transfer of MAbs (Pertuzumab, Aflibercept) from R&D to 5KL GMP scale.
- Managed upstream operations from vial revival to 1KL, 5KL bioreactor harvest.
- Conducted in-process analytics and supported cell bank qualification and documentation.
- Proficient in Minitab and GraphPad for process optimization and reporting.
Senior Research Associate – Upstream
Wockhardt Research Centre
12.2020 - 11.2022
- Developed upstream processes for viral vaccines and biosimilars (CHO, HEK293).
- Transferred processes from 5L to 200L scale for Sputnik V and other viral vaccines.
- Operated perfusion systems and supported GMP batch execution and DSP handover.
- Managed virus seed preparation and infection protocols for AAV vectors.
Executive – Upstream BBM
Intas Pharmaceuticals
07.2019 - 11.2020
- Operated fully automated upstream suites for biosimilars (Adalimumab Ranibizumab, Teriparatide, Filgrastim).
- Executed fermentation, harvesting, and cleaning validation activities.
- Maintained batch records and inventory of critical reagents and consumables.
Education
M.Tech - Pharmaceutical Technology & Biotechnology
NIPER
Mohali06-2019
B.Pharm - Pharmacy
RGTU
Bhopal06-2016
Skills
- Bioreactor Systems: Ambr_15Wave, Glass, STR (Sartorius), up to 5KL
- Software: eVAL, SAP, DocuSign, HMI, SCADA, WINCC, MFCS, UNICORN
- Analytics: CEDEX Bioanalyzer, Minitab, JMP, GraphPad
- Documentation: SOPs, BMRs, URS, IQ/OQ/PQ, TTD
- Recombinant DNA Therapeutics & Viral Vaccines
- Molecules: Aflibercept, Trastuzumab, Pertuzumab, Ranibizumab, Teriparatide, Darbepoetin, Insulin analogues
Timeline
Associate Manager – Upstream & Facility Setup
Medtherapy Biotech
05.2025 - Current
Scientist – Upstream R&D
Aurigene Pharmaceutical Services Ltd.
12.2023 - 04.2025
Senior Research Associate – MSAT Upstream
Zydus Research Centre
11.2022 - 11.2023
Senior Research Associate – Upstream
Wockhardt Research Centre
12.2020 - 11.2022
Executive – Upstream BBM
Intas Pharmaceuticals
07.2019 - 11.2020
M.Tech - Pharmaceutical Technology & Biotechnology
NIPER
B.Pharm - Pharmacy
RGTU