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Deputy General Manager - Downstream

Lambda Therapeutic Research
13+ years
3000000-5500000
Ahmedabad, India
10 May 22, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Deputy General Manager – Downstream (Biopharmaceutical Process Development)

Company: Lambda Therapeutic Research Ltd.
Location: Ahmedabad, India
Req ID: 1327
Date: May 21, 2026
CTC Range: ₹30,00,000 – ₹55,00,000 per annum


Company Overview

Lambda Therapeutic Research Ltd. is a global Clinical Research Organization (CRO) with operations across India, USA, UK, and Europe. The company provides end-to-end clinical and biopharmaceutical research services for innovator, biotech, and generic pharmaceutical industries, including advanced biologics and process development support.


Role Summary

The Deputy General Manager – Downstream is a senior leadership role responsible for:

  • Leading downstream process development for monoclonal antibody (mAb) purification

  • Overseeing biologics manufacturing process optimization and development

  • Managing technical teams working on bioprocessing and purification workflows

  • Supporting IND-enabling studies and regulatory submissions for biologics development


Key Responsibilities

1. Downstream Process Development

  • Lead development of downstream unit operations for mAb purification, including:

    • Clarification

    • Chromatography

    • Tangential Flow Filtration (TFF)

    • Formulation

  • Optimize purification processes for monoclonal antibodies and advanced biologics


2. Bioprocess Optimization & Scale-Up

  • Develop and execute:

    • Consistency batches

    • Engineering campaigns

    • Clinical trial material (DS) production

  • Conduct process characterization using Quality by Design (QbD) approach

  • Perform process capability and improvement studies


3. Advanced Biologics & Technology Development

  • Evaluate and implement new technologies for cost-effective mAb purification

  • Work on advanced molecules such as:

    • Bispecific antibodies

  • Improve capture and purification strategies


4. Regulatory & Documentation Support

  • Author and review technical reports

  • Contribute to regulatory submissions supporting IND-enabling studies

  • Support viral clearance studies and process validation documentation

  • Ensure compliance with regulatory expectations for biologics development


5. Cross-Functional & External Collaboration

  • Collaborate with external CROs for viral clearance studies

  • Coordinate with internal and external stakeholders for process development programs

  • Support project execution across global teams


6. Team Leadership & Mentoring

  • Build and manage a high-performing technical team

  • Guide and mentor subordinates in downstream bioprocess development

  • Support career development and technical capability building


Required Experience & Qualifications

Educational Qualification

  • M.Tech + PhD in Biochemical Engineering (preferred) with 13+ years experience
    OR

  • B.Sc / M.Sc in Biochemical Engineering or equivalent with 15+ years experience


Required Experience

  • Strong experience in mAb purification process development from mammalian cell lines

  • Background in biopharma, biotech, or CRO environments

  • Experience leading teams in downstream bioprocess development (preferred)


Required Skills & Competencies

  • Expertise in downstream biologics processing

  • Strong knowledge of:

    • Chromatography techniques

    • TFF systems

    • Viral clearance studies

    • QbD (Quality by Design) principles

  • Regulatory understanding of biologics development

  • Strong leadership and team management skills

  • Strategic thinking and process innovation capability


Work Environment

  • Based in Ahmedabad, India

  • Biopharmaceutical R&D and process development environment

  • High-complexity biologics development projects

  • Global collaboration with CRO partners and regulatory stakeholders


Role Impact

  • Enables development of advanced biologic therapies (mAbs, bispecifics)

  • Supports IND-enabling manufacturing processes

  • Improves efficiency and scalability of biologics production

  • Plays a key role in bringing novel biologics into clinical development


Career Level

  • Senior leadership / Deputy General Manager level

  • Strategic technical leadership role in biologics development

  •