Scientist III, QC Life Cycle

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Scientist III, QC Life Cycle

Columbus, OH

 

Overview

 

Perform non-commercial qualitative, and quantitative developmental chemical and physical testing for highly technical projects, as specified by compendia (United States Pharmacopeia or “USP”, Japanese Pharmacopoeia or “JP”, and British Pharmacopoeia or “BP”), regulatory authority (FDA & ICH) for starting materials, packaging components, intermediates and finished products.

 

Responsibilities

Review and approve test results to ensure that consistent quality standards are met. Interface with new products for analysis, development and validation in order to facilitate appropriate and consistent compliance and approaches. Perform analytical transfers for multi-source and brand products internally and externally. Conduct gap analysis of current and older validation reports to ensure that consistencies in compliance with national and international quality standards are met. Develop and validate analytical methods to meet Standard Operating Procedures (“SOPs”), ICH, FDA, JP, EP, USP, Europe, Middle East, and Africa (“EMEA”) requirements. Coordinate validation and chromatographic data to assist/write technical reports. Develop and implement policy and procedures to ensure consistent regulatory compliance. Lead project(s) and perform continuous improvement activities. Provide technical assistance from early stage development and small scale operations through full production and life- cycle management. Remote work permitted up to 1 week per month.

 

Qualifications

 

Must have a bachelor’s degree in Chemistry, Pharmaceutics, a closely related engineering/science field, or the equivalent and five years of progressive post baccalaureate experience in any occupation which includes analytical chemistry in the Pharmaceutical Industry, including five years of experience in 1) execution, validation, and transfer of analytical methods for evaluation and release of Active Pharmaceutical Ingredients (APIs) or Pharmaceutical products; 2) compendia and non-compendia testing; and 3) FDA/ICH guidance and national Pharmacopeias.

 

Those interested in this position, send CV to columbusrecruiting@hikma.com (ID: 5580).