Position 

Pharmaceutical Product Development Scientist

Job Description

We are currently seeking an experienced Pharmaceutical Product Development Specialist to join our team. The key focus is design and execution of studies related to pre-formulation and formulation development, analytical methods development and validation, and various other associated pharmaceutical product development studies, geared towards development of new drug products in accordance with the FDA regulatory requirements.

Educational Qualification: Master’s Degree in Pharmaceutical Sciences or related field

Responsibilities:

·         Establish Product Profile and Critical Quality Attributes for Sterile Solutions, Sterile Suspension, and Lyophilized pharmaceutical parenteral products

·         Conduct and manage research and developmental studies to determine product feasibility using various analytical techniques

·         Design of Experiments, Prepare and Execute Study Protocols and Generate Study Reports for product development aimed at establishing Critical Process Parameters.

·         Analytical Development and Pre-Validation Studies, Generate and Execute Method Validation Protocols as per ICH and Compendial guidelines, and Prepare Study Reports for analytical method for testing API and Drug Product

·         Conduct stability on lab scale batches and interpret data to propose shelf life of product

·         Liaise with Quality Control and Manufacturing for technology transfer of laboratory development activities

·         Preparation of product development reports and related documents for regulatory submission

·         Establish specification for Release and Stability Testing of Active Pharmaceutical Ingredients and Drug Product

·         Prepare Standard Operating Procedures for test methods

·         Generate documents to support regulatory submission

·         Qualification and Maintenance of an FDA-

       registered, cGMP R&D laboratory

How to Apply 

Send resume by postal mail to:

Human Resources

GRAM Laborarories, Inc.

1761 Kaiser Avenue

Irvine, CA 92614