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Deputy General Manager - Downstream

Lambda Research Accelerated
Lambda Research accelerated
13-15+ years
INR 30 – 55 Lacs per annum
Ahmedabad, Gujarat, India
10 Feb. 20, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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
Deputy General Manager Biologics Jobs Ahmedabad, Downstream Process Development Careers India, mAb Purification Leadership Roles, Biopharma Downstream Jobs Gujarat, Viral Clearance Studies Biotech Careers, Biochemical Engineering Jobs India, Biologics Process Development CRO

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.