Deputy General Manager - Downstream

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

• Provide technical leadership for process development of downstream unit operations for purification of monoclonal antibodies (mAbs) with unit operations ranging from clarification, chromatography, TFF and formulation.

• To strengthen the capabilities to develop in depth understanding of downstream process development, consistency batches, engineering campaign, Clinical Trial campaign, generation of DS for pre-clinical and clinical studies, virus validation, process improvement, process characterization using QbD approach, process capability studies, cleaning validation and resin/TFF reuse studies.

• Should be focused on assessing recent technologies for development of cost-effective newer technologies for capture and purification of mAbs, and advanced molecules like bispecifics.

• Must collaborate and network with CROs for completion of viral clearance studies.

• Responsible for authoring and reviewing technical reports, mAb purification unit operations, viral clearance studies 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.

EXPERIENCE

• MTech with PhD in Biochemical Engineering or equivalent with 13+ years or Bsc/ MSc in Biochemical Engineering or equivalent with 15+ years of work experience developing mAb purification processes from mammalian cell lines in biopharma/biotech or relevant contract research labs.