3 Days Left Development Associate

3 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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