Senior Manager

ORGANISATIONAL OVERVIEW We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities. Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality to help clients develop products safely, effectively, and quickly. Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team. JOB DETAILS The candidate should play a crucial role in designing, executing, analysing experiments related to development of mAb upstream processing function within the Process Sciences group.  The role entails utilization of the prospective candidate’s vast technical experience to lead a team that will be focused on multiple unit operations for upstream monoclonal antibodies for manufacturing of drug substance of clinical grade product quality. KEY DELIVERABLES Provide technical leadership for process development of upstream unit operations for manufacturing of monoclonal antibodies (mAbs). Have significant understanding in development of mAb upstream processes. To strengthen the capabilities to develop in depth understanding of upstream process development, consistency batches, generation of DS for pre-clinical and clinical studies, virus clearance validation, process improvement, process characterization using QbD approach and  process capability studies. Well experienced in managing unit operations in GMP including assessment of hold time stability of process streams in each upstream operation. Must actively work with the cell culture team in transferring the process for mAb manufacturing. Should be focused on assessing recent technologies for development of cost-effective newer technologies for manufacturing of mAbs. Should have strong understanding of softwares used for automation of upstream operations. ALLIED RESPONSIBILITIES Highest integrity, committed to ethics and scientific standards. Uses an approach to address the task or situation such as delegation, planning, timelines. Perseveres to find ways to work through localized challenges or barriers. Empowers team members and encourages them to contribute their skills/ideas. Gets the right talent mix for the task. Shares…