Research Associate – Cell & Gene Therapy QC (Micro)

• MSc /MTech (Specialization in any Life Sciences) with 1-5 years’ experience

Job Description, Key Skills, and Competencies:  

• Conduct Environmental Monitoring in controlled and Classified areas at CGT Facility

• To prepare the Microbiological culture media
• Conduct fumigation/fogging in the clean rooms at CGT facility
• Preparation of Disinfectants and Reagents on daily basis
• Preparation of SOPs, protocols and reports pertaining to the program requirements
• Conduct Water Sampling and Water analysis as per schedule
• To perform microbiological validations
• To Receive, Storage and Handling of Microbiology consumables
• To Sterilize the porous and non-porous goods loads
• To perform Bacterial Endotoxin Test and Sterility Test for Drug Substances and Drug product
• To perform Growth Promotion Test for Microbiological cultural Media
• To handle standard Microbial cultures and Environmental Isolates
• To perform culture suspension preparations and Inoculum determinations
• Responsible for Cleaning, Sanitization, handling, and status verification for instruments like water bath, weighing balance, pH meter, Hot air oven, Biosafety cabinets, HPHV Steam sterilizer, Dry block incubator, Lab Incubators but not limited to
• Preparation of Environmental monitoring Trends and analytical trends for microbiology activities
• Excellent communication to interface with internal functional departments to support the workflow of various study-related activities
• Coordinate with manufacturing, quality assurance, supply chain teams and strictly adhere to project timelines by preserving integrity, accuracy, safety, and quality
• Prepare and involve in compliance monitoring inspections and regulatory agency interactions
• Provide scientific/technical due diligence support for business development activities as required
• Able to troubleshoot experiments, analyse data and interpret scientific presentations
• Understanding of systems and process pertaining to sterile practices, work ethics, safety, health, and environment

Competencies:

• Excellent communication & presentation skills  • Hands on excel skills
• Good interpersonal skills