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Deputy General Manager - Downstream

15+ years
INR 30,00,000 – 55,00,000
10 Oct. 7, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Req ID: 1327
Date Posted: October 1, 2025
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
CTC Range: INR 30,00,000 – 55,00,000


Organizational Overview

Lambda Therapeutic Research is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with operations in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland).

Key Highlights:

  • Offers comprehensive end-to-end clinical research services to global innovator, biotech, and generic pharmaceutical companies

  • Focused on innovation, quality, and regulatory compliance in clinical research and biopharma development


Job Overview

The Deputy General Manager – Downstream will provide technical leadership for the process development of downstream unit operations in monoclonal antibody (mAb) purification. This role focuses on innovative process development, process characterization, regulatory support, and team leadership.


Key Responsibilities

  • Lead downstream unit operations: clarification, chromatography, TFF, and formulation for mAb purification

  • Develop and strengthen capabilities in:

    • Consistency batches and engineering campaigns

    • Clinical trial campaigns

    • Generation of drug substance (DS) for pre-clinical and clinical studies

    • Virus validation and process improvement

    • Process characterization using QbD approaches

    • Process capability studies, cleaning validation, resin/TFF reuse studies

  • Assess new and cost-effective technologies for mAb and advanced molecule purification (e.g., bispecifics)

  • Collaborate with CROs for viral clearance studies

  • Author and review technical reports, unit operations, viral clearance studies, and regulatory submissions to support IND-enabling data

  • Develop and mentor a highly capable technical staff, providing guidance and professional development


Required Experience

  • MTech + PhD in Biochemical Engineering or equivalent with 13+ years experience, or

  • BSc/MSc in Biochemical Engineering or equivalent with 15+ years experience in mAb purification processes from mammalian cell lines in biopharma/biotech or contract research labs

  • Prior experience leading a team in biopharma organizations focusing on mAb downstream operations is preferred


Skills & Competencies

  • Expertise in mAb purification, downstream process development, and virus validation

  • Strong technical leadership and team management skills

  • Knowledge of QbD, process characterization, and regulatory documentation

  • Ability to collaborate with CROs and cross-functional teams

  • Strong mentoring and professional development abilities