Job Description

🌟 Laurus Labs is Hiring: Quality Control Managers – ADC & Gene Therapy
📍 Location: Laurus Labs, Shamirpet, Hyderabad
🔬 Division: Advanced Biologics – Quality Control
🧬 Platforms: Antibody Drug Conjugates (ADC) & Gene Therapy (GT)

Laurus Labs is expanding its cutting-edge biologics facility and seeking passionate, detail-driven professionals to lead Quality Control functions across three specialized domains. If you’re ready to shape industry benchmarks in compliance, innovation, and team empowerment—this is your moment.

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🧪 Position 1: Manager & Asst Manager– Physico-Chemical Analysis (ADC & GT)

Key Responsibilities:
– Lead analytical characterization of ADCs and GT products across development and commercial stages
– Design and execute stability studies, method validations, and release testing
– Ensure compliance with global regulatory standards (FDA/EMA/CDSCO)

Required Expertise:
– Hands-on experience with:
– Capillary Electrophoresis
– HPLC (HIC, RP, NP, SEC)
– LC-MS (preferred)
– Strong understanding of QbD principles and CQA/QTPP alignment
– Experience in drafting SOPs, protocols, and regulatory documentation

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🧫 Position 2: Manager & Assistant Manager– Bioassays

Key Responsibilities:
– Develop and validate cell-based potency assays, binding assays, and cytotoxicity assays
– Oversee assay lifecycle management and troubleshooting
– Collaborate with cross-functional teams for method transfer and regulatory submissions

Required Expertise:
– Cell culture and assay development for biologics
– ELISA, flow cytometry, and other immunoassay platforms
– Familiarity with ICH guidelines and statistical analysis of bioassay data

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🧴 Position 3: Assistant/ Deputy Manager – Raw Material Testing

Key Responsibilities:
– Manage release testing of raw materials for upstream/downstream processes and drug product
– Ensure traceability, vendor qualification, and compliance with pharmacopeial standards
– Support investigations, change controls, and audit readiness

Required Expertise:
– Analytical testing of excipients, buffers, and media components
– Experience with compendial methods (USP/EP/IP)
– Knowledge of GMP documentation and material lifecycle management

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💼 What We Offer:
– A mission-driven culture focused on innovation, compliance, and team growth
– Opportunities to shape regulatory strategy and facility excellence
– Competitive compensation and career development pathways

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📩 Interested candidates can send their CV to HR: vikram.singh@lauruslabs.com with subject line: QC Manager – ADC/GT.