Responsible for researching, formulating, and prototyping new oral, topical OTC, and NDA/ANDA drug products as part of product development initiatives.
This position will be a subject matter expert on product formulation and manufacturing scale up. May document and publish peer reviewed journals.
Research, formulate, and prototype new oral, topical OTC, and NDA/ANDA drug products.
Characterize prototype formulations for function, stability, compatibility, and overall product quality.
Evaluate new technologies and products.
Author and review experimental protocols, development reports, and technology transfer reports.
Support formulation scale up to manufacturing sites and new product implementation process. Collaborate with domestic and international manufacturers to troubleshoot problems that arise.
Work with legal to identify opportunities to protect product formulations through patents, trademarks, or other intellectual property techniques.
Manage assigned projects by coordinating timelines and balancing project priorities. Ensure product formulations meet all product specifications.
Review ingredient lists, formulas, and raw materials for compliance with FDA/INCI guidelines.
Proactively work with members of the division or project team to identify issues and provide solutions.
Bachelor's degree in Pharmaceutical Science, Chemistry, Chemical Engineering or related science field.
At least 7 years of experience in pharmaceutical or cosmetic formulation development.
Knowledge of batch manufacturing and process scale up.
PREFERRED JOB REQUIREMENTS
Master's degree in Pharmaceutical Science, Chemistry, Chemical Engineering or related science field
Experience in project management.
Knowledge of liquid, semi-solid, and gel based formulations; suspensions; or emulsions
Technical understanding of regulatory pathways related to cosmetic, OTC, monograph, NDA/ANDA drugs.
Position requires travel up to 10% of the time for business purposes (domestic and international).
Medline Industries, Inc.