Development Associate

7 days ago

Mumbai, Maharashtra, India Zelle Biotechnology Pvt. Ltd. Full time

Role Definition / Purpose:The Development Associate will be responsible viral clearance or purification process developmentResponsibility / Deliverables:Report to the lead in Viral clearanceEnsure that GLP guidelines are followedPerform 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 conditionsMaintain 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 TRSCollaborate with analytical and virology teams for post-processing sample transferOperate and calibrate downstream equipment including AKTA systems, TFF setups, and sterile filtration unitsEnsure cleaning, qualification, and preventive maintenance of downstream processing equipmentRecord process parameters, step yields, and relevant observations during executionLabel and store processed samples per study requirements and safety protocolsTransfer processed samples to the relevant teams as per predefined timelinesParticipate in deviation handling, risk assessments, and change control processesAdhere to safety protocols and report any incidents, non-conformances, or atypical events promptlyKey Competencies:Knowledgeable in appropriate Viral Clearance and GLP guidelines (including ICH Q5A and OECD Guidance etc.)Must be detailed oriented and have excellent organizational skillsMust possess effective written and oral communication skills.Must display a high degree of professionalism and confidentialityQualification:Masters in a Life Sciences discipline or other relevant areaExperience:3+ years of relevant experience including a minimum of 1+ year of related work experience in viral clearance or purification process development2+ years of experience working in a lab environment under GLP guidelines

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