Location: Mumbai
Role Overview:
The Development Associate/ Sr. – Jr. Development Assistant will be responsible viral clearance or purification process development
Key Responsibilities:
• Report to the lead in Viral clearance
• Ensure that GLP guidelines are followed
• Perform a wide range of analyses (routine and non-routine) primarily but not limited to the molecular, cell biology, and virology test areas of Biopharmaceutical Services, cell culturing, plaque assays, and virus production.
• Review and evaluate raw data for acceptability
• Set up and validate new analytical or related processes used by the department.
• Follow appropriate and technically valid Standard Operating Procedures (SOPs).
Ensure documented approval of the study plan and amendment(s) by the Study Director and ensure that the approved study plan and amendment(s) are made available to the quality assurance personnel by the Study Director
Key Competencies:
Masters in a Life Sciences discipline or other relevant area.
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
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.
