Job Title:  Drug Product Formulation Development Scientist

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 design and execute formulation development studies for drug product within the Process Sciences group.  The role is critical to the delivery of a suitable formulation in the appropriate DP dosage form (liquid/lyo) and possessing desired physico chemical characteristics.

KEY DELIVERABLES

• Provide technical leadership for DP formulation and lyophilization development and characterization.
• Strong understanding of design of formulation studies and selection of appropriate excipients for different dosage forms (liquid/lyo) and stability studies in order to design and develop suitable formulation in the appropriate DP dosage form (liquid/lyo) and possessing desired physico chemical characteristics.
• Perform studies for selection of primary packaging container and design/execute compatibility studies.
• Perform forced product degradation studies.
• Strong understanding of DP unit operations like freeze/thaw, filtration, filling, lyophilization
• Good collaboration skills with clients
• Responsible for authoring and reviewing technical reports related to drug product, and contribute to regulatory submissions and audits with health agencies.
• Contribute to publications/IP around formulations

EXPERIENCE

• Strong understanding of design of formulation studies and appropriate excipients for different dosage forms (liquid/lyo) and stability studies
• Strong understanding of DP unit operations like freeze-thaw, filling, filtration, mixing, lyophilization, container closure integrity testing and packaging operations is desirable.
• Cross functional technical knowledge is highly desirable.
• Excellent oral and written communication and interpersonal skills will be desired.

EDUCATIONAL QUALIFICATION

Masters or Ph.D  in Chemical/Biochemical Engineering or similar disciplines with 5+ years of work experience in drug product formulation development and manufacturing.