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Job Title:

Development Associate (Virologist)

Company: Zelle Biotechnology Pvt. Ltd.

Location: Mumbai, Maharashtra

Created: 2025-08-23

Job Type: Full Time

Job Description:

Role Definition / Purpose: The Development Associate will be responsible viral clearance or purification process development Responsibility / Deliverables: Report to the lead in Viral clearance Ensure that GLP guidelines are followed Perform downstream unit operations such as chromatography, filtration, or low pH inactivation as per the study protocol or client method. Handle and process virus-spiked samples under appropriate biosafety and GLP-compliant conditions Maintain accurate and complete documentation in lab notebooks, batch records, and equipment logs. Follow applicable SOPs, study protocols, and regulatory guidelines such as ICH Q5A and WHO TRS Collaborate with analytical and virology teams for post-processing sample transfer Operate and calibrate downstream equipment including AKTA systems, TFF setups, and sterile filtration units Ensure cleaning, qualification, and preventive maintenance of downstream processing equipment Record process parameters, step yields, and relevant observations during execution Label and store processed samples per study requirements and safety protocols Transfer processed samples to the relevant teams as per predefined timelines Participate in deviation handling, risk assessments, and change control processes Adhere to safety protocols and report any incidents, non-conformances, or atypical events promptly Key Competencies: Knowledgeable in appropriate Viral Clearance and GLP guidelines (including ICH Q5A and OECD Guidance etc.) Must be detailed oriented and have excellent organizational skills Must possess effective written and oral communication skills. Must display a high degree of professionalism and confidentiality Qualification: Masters in a Life Sciences discipline or other relevant area Experience: 3+ years of relevant experience including a minimum of 1+ year of related work experience in viral clearance or purification process development 2+ years of experience working in a lab environment under GLP guidelines

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