Job Title:  Deputy 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 downstream 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 purification monoclonal antibodies for manufacturing of drug substance of clinical grade product quality.

• Should be focused on assessing recent technologies for development of cost-effective newer technologies for capture and purification of mAbs.
• Overseeing and maintenance of all purification skids/columns including the ones available at lab pilot and manufacturing scale
• Should have strong understanding of softwares used for automation of purification operations.
• Must be focused on usage of statistical tools to evaluate process performance and process consistency.
• 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.
• Establish and maintain a library of purification materials such as resins and filtration cassettes.
• Assist in the tech transfer of developed processes to pilot and/or GMP manufacturing facilities.
• Have significant understanding in development of mAb purification processes in GMP.

EXPERIENCE

• 6  to 10 years developing mAb purification 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 downstream unit operations.

EDUCATIONAL QUALIFICATION

• BE in Biochemical Engineering or Chemical Engineering, MTech with PhD in Biochemical Engineering/Biological Sciences.