Principal Scientist, Injectables Analytical Research

Bedford, OH

Overview

Complete analytical projects in support of the development of a manufacturable multisource injectable pharmaceutical product.

Responsibilities

Conduct testing, analytical method development, and validation in support of regulatory submissions and product launches. Identify and perform analytical tasks in support of product development, registration lot release, and pre- and post-regulatory submission activities. Develop workable action plans. Participate in method transfer activities and troubleshoot and improve analytical methods. Coordinate analytical activities to meet the business deadlines. Perform activities within the assigned timelines and in compliance with cGXPs, regulatory requirements, and company practices and procedures. Perform analytical method development, validation, and project support. Transfers analytical methods globally for validation and stability testing. Experienced in the analytical development aspects of complex injectables, including by not limited to emulsions, peptides and suspensions. Identify, offer, and implement contingency plans to prevent and overcome analytical issues and perform method trouble shooting. Identify process improvements to refine current systems and improve efficiency. Conduct trainings on selected topics of interest for the department. Review and verify analytical data generated by peers and maintain integrity of data. No remote work permitted.

Qualifications

Must have a bachelor’s degree in pharmacy, chemistry, related, or equivalent and Must have five years of progressive post baccalaureate experience in 1) the development, validation, execution and transfer of analytical methods for Active Pharmaceutical Ingredients and injectable sterile drug products (including suspensions, peptides and emulsions); 2) High-performance liquid chromatography, mass spectrometry, dissolution; 3) laboratory data acquisition software; and 4) FDA and ICH regulations and guidelines.

Those interested in this position, send CV to columbusrecruiting@hikma.com (ID: 5567).