VIJAY SINGH

Skilled, result oriented scientist with 13yr+ exp in biopharma with R&D, MSAT and manufacturing function Downstream of mAbs, biosimilars, Fusion proteins, antibodies, gene therapy, vaccines, viral vectors, mRNA

About

**Skilled, highly motivated and result oriented scientist with 13yr+ experience in biopharma with R&D, MSAT and manufacturing function (Upstream/Downstream) of large molecules (mAbs, biosimilars, Fusion proteins, Bispecific antibodies, ADC), gene therapy, cell therapy, vaccines, viral vectors, mRNA and pDNA therapeutics,** **Process development, scale-up to manufacturing, GMP manufacturing, experience in FDA approved manufacturing facility as client and customer perspective. Viral clearance strategies and CMC expert**

Education

Institute of Chemical Technology

M.Tech, Bioprocess technology / July, 2010

Mumbai

Punjab Technical University

B.Pharmacy, Pharmaceutical Sciences / May, 2008

Kapurthala Town

Experience

APC

Senior Bioprocess Scientist / March, 2022 — Present

Function as a Project Technical Lead for downstream process projects in large molecule business unit. • Collaborating and working closely with various internal stake holders for downstream process deliverables and timelines. • Client Collaboration, technical, project and resource planning

Biocon Biologics

Associate Scientific Manager / June, 2019 — February, 2022

• Leading and assisting the team of Scientists and senior scientist, involved in the development, scale-up and technology transfer. • Downstream process optimization and development of Biotherapeutics (Monoclonal antibody) • Scale up and technology transfer from R&D to manufacturing process for Monoclonal antibodies • Designing, Planning Viral validation strategy for pharmaceutical manufacturing

AVANTOR PERFORMANCE MATERIAL INDIA

ASSISTANT MANAGER -TECHNICAL BIOPHARMA / May, 2017 — May, 2019

Functional Responsibilities: Part of Strategic Growth Technical global team-Biopharma. Product Portfolio: Single Use Solutions, Chromatographic resins, Bioprocess chemicals- Salts, Buffer, Excipients, Bovine Serum • Biopharma Account pipeline mapping, Identify and develop new customers where in solution can be provided • Identify the unique process needs of customer for customized solutions throughout the Bioprocess development (Upstream, Downstream, Formulation process) with Avantor product portfolio • Assessing customer potential and provide forecast for sales planning

BIOCON BIOLOGICS INDIA LIMITED

PRINCIPAL SCIENTIST / December, 2012 — April, 2017

Scale down qualification for manufacturing support and characterization studies. • Resin Lifetime study for all chromatographic steps (Affinity, AEX, CEX, HIC) for bio-similar mAb project

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