Job Title:  Technical Lead, Upstream Development

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

• Technically proficient in cell culture related sterile operations.
• Highly skilled in project planning and execution to ensure timely completion.
• Managing upstream process related tasks such as autoclaving, STR, and wave bioreactor setup, instrument calibration, and lab record maintenance.
• Must have experience in working with AMBR 15 and AMBR 250 for screening and optimization.
• Must have experience of handling with 50L and 200L disposable bioreactors in GMP suites.
• Proficient in process analysis instruments handling including Vi cell analyzer, BGA, CEDEX.
• Process optimization for high yield and to achieve targeted CQA.
• Having excellent writing skill in technical protocols and reports writings
• Scale up of optimized process and responsible for execution of consistency batches at 50L and 200L scale.
• Knowledgeable in QBD-based process development, and scale-up/down processes and process characterization.
• Skilled in data collation, presentation, and analysis using various DOE software such as Minitab and JMP
• Lab Documentation and lab compliance: Capable of supporting tech transfer activities and process optimization, troubleshooting deviations, and preparing various documents including process development reports and CAPA documentation.
• Write and review Electronic notebook experimental data.

EXPERIENCE

• 6 to 10 years of experience developing mAb upstream processes from mammalian cell lines in biopharma/biotech or relevant contract research labs.
• Preference will be for personnel having prior experience in leading a team in biopharma organizations that focus on mAb upstream processing unit operations.

EDUCATIONAL QUALIFICATION

• MSc/ MTech/ PhD in Biotechnology.