Development Associate

2 weeks ago

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

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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