Job Title:  Senior Manager

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 aseptic operations.
• Provide technical leadership for upstream process development unit operations for monoclonal antibodies (mAbs).
• Have significant understanding in development of mAb upstream processes.
• Familiar with design of experiments and QbD approach for process development.
• Should be familiar with cell bank preparation and characterization activities.
• To strengthen the capabilities to develop in depth understanding of upstream process development, consistency batches, engineering campaign, Clinical Trial campaign, generation of DS for pre-clinical and clinical studies, process improvement, process characterization, process capability studies, cleaning validation.
• 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.
• Well experienced with glass, single use and SS bioreactors. Familiar with ATF system.
• Must actively work with the downstream processes in transferring the processes for mAb purification.
• Should be focused on assessing recent technologies for development of cost-effective newer technologies for mAbs yields improvements.
• Overseeing and qualification, validation and maintenance of all process equipment that one’s available at lab pilot and manufacturing scale.
• Responsible for authoring and reviewing technical reports, mAb upstream unit operations, and portions of regulatory submissions to support IND enabling data to initiate early development clinical trials.
• Develop and maintain a highly capable and dedicated technical staff. Guide subordinates in carrying out responsibilities and mentor them in their professional development

KEY DELIVERABLES

• Process development, Scale up and technology transfer
• Planning and team management
• Document writing and review
• Detailed data analysis and design of experiment
• Cross functional team discussions and allignment

ALLIED RESPONSIBILITIES

• the candidate should also be proficient in cGMP operations
• Strong organizational skills, including the ability to prioritize personal and professional workload
• Very good understanding and implementation of the best documentation practices including paper and electronic record keeping
• Sufficient industry experience in handling cross functional interactions

EXPERIENCE

• 8 to 14 years of experience in developing mAb upstream processes from mammalian cell lines in biopharma/biotech or relevant contract research labs

EDUCATIONAL QUALIFICATION

• MSc/ MTech/ PhD in Biotechnology