Manager - Downstream Processing

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

• Provide technical leadership for DP formulation and lyophilization development and characterization wrt to strategy, designing, executing, and analyzing experiments for Drug substance and Drug product mAb formulation processing within the Process Sciences group.

• Strong understanding of design of formulation studies and selection of appropriate excipients for different dosage forms (liquid/lyo) and stability studies to design and develop suitable formulation in the appropriate container closure and DP dosage form (liquid/lyo) and possessing desired physico-chemical characteristics.

• Independently conduct DOE based screening experiments with high throughput formulation development, analyze experimental data, and optimize formulation compositions.

• Perform forced product degradation studies.

• Responsible for preparing technical documentation, such as protocols and reports, SOPs, and presentations, to support the technology transfer of processes to larger scales.