Job Title: Deputy Manager – Downstream Process Sciences (mAb Purification)
Job ID: 1501
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
CTC Range: INR 10 – 15 Lacs per annum
Company Overview
Lambda Therapeutic Research Ltd. is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with operations across India, Poland, UK, and the United States. With over 20 years of expertise in clinical research and biologics development, Lambda delivers full-spectrum clinical trial and process development solutions to biopharmaceutical and generic drug companies worldwide.
The organization is driven by scientific innovation, regulatory excellence, and a strong commitment to quality in biologics and monoclonal antibody development.
Job Summary
Lambda Therapeutic Research Ltd. is seeking a Deputy Manager – Downstream Process Sciences to support and lead monoclonal antibody (mAb) purification process development within the Process Sciences group. The role involves designing, executing, and analyzing downstream experiments to support clinical-grade drug substance manufacturing.
The selected candidate will provide technical leadership across multiple purification unit operations and contribute to regulatory documentation, viral clearance studies, and technology transfer initiatives within a GMP-compliant biologics environment.
Key Responsibilities
Downstream Process Development & Execution
Design and execute experiments related to monoclonal antibody downstream processing.
Lead purification activities including clarification, chromatography, filtration, and related unit operations.
Support manufacturing of clinical-grade drug substance with focus on product quality and regulatory compliance.
Evaluate and implement cost-effective and advanced capture and purification technologies for mAbs.
Technical & Operational Oversight
Oversee and maintain purification skids and chromatography columns at laboratory, pilot, and manufacturing scales.
Demonstrate strong understanding of automation software used in purification operations.
Utilize statistical tools to evaluate process performance, robustness, and consistency.
Establish and maintain a technical library of purification materials including chromatography resins and filtration cassettes.
Regulatory & Compliance Support
Collaborate with CRO partners to complete viral clearance studies.
Author and review technical reports related to mAb purification unit operations and viral validation studies.
Contribute to regulatory submissions supporting IND-enabling studies and early-phase clinical trials.
Ensure strong compliance with GMP standards in downstream biologics process development.
Technology Transfer & Cross-Functional Collaboration
Support technology transfer of developed processes to pilot and GMP manufacturing facilities.
Work closely with cross-functional teams including QA, manufacturing, and regulatory affairs.
Mentor junior team members and provide technical guidance where required.
Educational Qualification
B.E. in Biochemical Engineering or Chemical Engineering
OR
M.Tech with Ph.D. in Biochemical Engineering or Biological Sciences
Experience Required
6 to 10 years of hands-on experience in developing monoclonal antibody purification processes from mammalian cell lines.
Prior experience in biopharma, biotech, or contract research laboratories is mandatory.
Experience leading or supervising a downstream processing team in a biologics environment will be preferred.
Core Technical Expertise
Monoclonal Antibody (mAb) Downstream Processing
Chromatography & Filtration Systems
Viral Clearance Studies
GMP Biologics Manufacturing
Process Characterization & Statistical Analysis
Automation Software for Bioprocessing
IND-Enabling Documentation Support
SEO & GEO Optimized Keywords
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Why Join Lambda Therapeutic Research Ltd.
Lambda offers scientists and bioprocess professionals the opportunity to work on advanced monoclonal antibody programs within a globally integrated CRO framework. This role provides exposure to GMP manufacturing, regulatory submissions, viral validation studies, and innovative downstream technologies supporting global biologics development.
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