Job Title: Deputy General Manager – Downstream Process Development
Job ID: 1327
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
CTC Range: INR 30 – 55 Lacs per annum
Company Overview
Lambda Therapeutic Research Ltd. is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India. With operational presence across India, USA, Canada, Spain, UK, and Poland, Lambda delivers comprehensive clinical and bioanalytical research solutions to innovator, biotech, and generic pharmaceutical companies worldwide. The organization is recognized for scientific excellence, regulatory compliance, and advanced biologics development capabilities.
Job Summary
Lambda Therapeutic Research Ltd. is seeking an experienced Deputy General Manager – Downstream Process Development to lead monoclonal antibody (mAb) purification programs and advanced biologics downstream operations. This leadership role is responsible for overseeing process development, viral clearance studies, regulatory documentation, and technology evaluation for cost-effective purification of biologics, including mAbs and bispecific antibodies.
The ideal candidate will possess deep technical expertise in downstream bioprocessing, strong leadership capabilities, and proven experience in biologics development within biopharma, biotech, or contract research organizations.
Key Responsibilities
Technical Leadership & Process Development
Lead downstream unit operations for monoclonal antibody purification including clarification, chromatography, tangential flow filtration (TFF), and formulation.
Drive process development activities for consistency batches, engineering campaigns, clinical trial campaigns, and drug substance (DS) generation for pre-clinical and clinical studies.
Implement virus validation strategies and oversee viral clearance studies in collaboration with CRO partners.
Apply Quality by Design (QbD) principles for process characterization and process capability studies.
Lead cleaning validation programs and resin/TFF reuse studies.
Evaluate and implement innovative, cost-effective capture and purification technologies for mAbs and advanced molecules such as bispecific antibodies.
Regulatory & Documentation Oversight
Author and review technical reports related to mAb purification unit operations and viral clearance studies.
Contribute to regulatory submissions supporting IND-enabling studies and early-phase clinical trials.
Ensure regulatory compliance aligned with global biologics development standards.
Strategic & Team Leadership
Build, mentor, and manage a high-performing downstream process development team.
Guide team members in technical execution and professional development.
Foster collaboration with cross-functional departments and external partners.
Strengthen organizational capabilities in biologics downstream processing and advanced purification technologies.
Education Requirements
M.Tech with Ph.D. in Biochemical Engineering or related discipline with 13+ years of relevant experience
OR
B.Sc./M.Sc. in Biochemical Engineering or equivalent with 15+ years of relevant industry experience
Experience Required
Minimum 13–15+ years of hands-on experience in developing monoclonal antibody purification processes from mammalian cell lines.
Proven track record in downstream processing within biopharma, biotech, or contract research laboratories.
Prior experience leading technical teams in biologics downstream operations is highly preferred.
Core Technical Expertise
Monoclonal Antibody (mAb) Downstream Processing
Chromatography & TFF Operations
Viral Clearance & Virus Validation Studies
Quality by Design (QbD)
IND-Enabling Regulatory Documentation
Biologics Process Characterization
Cleaning Validation & Resin Reuse Studies
SEO & GEO Optimized Keywords
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Why Join Lambda Therapeutic Research Ltd.
Lambda provides senior scientific leaders with the opportunity to shape advanced biologics development programs within a globally recognized CRO environment. This role offers exposure to cutting-edge monoclonal antibody technologies, regulatory submissions, and international collaboration while contributing to innovative therapeutic development.
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