Job Description

·       Perform non-commercial qualitative and quantitative chemical and physical testing as specified by compendia (USP, JP, BP) regulatory authority (FDA & ICH) for starting materials, packaging components, intermediates and finished products

·       Review and approve test results to ensure consistent quality standards are met. Author technical reports for development and validation of analytical methods.

·       Interface with new products analysis, development and validation in order to facilitate appropriate, consistent compliance and approaches.

·       Perform analytical method transfers.

·       Perform gap analysis of current and older validation reports to ensure consistencies in compliance with national and international quality standards are met.

·       Maintain laboratory data in an orderly manner in laboratory documentation. Performs analytical tasks in compliance with cGMP’s, cGLP’s FDA and ICH guidelines to support regulatory submissions and maintain laboratory cleanliness.

·       Develop and validate analytical methods to meet SOP’s, ICH, JP, EP, USP, EMEA, and FDA requirements

·       Mentor and train analysts on new or approved methods, techniques and instrumentation to ensure compliance.

·       Coordinate internal and external analytical resources ensuring that project timelines are met.

·       Participate in cross-functional teams

·       Provide technical expertise to internal and external customers to support business objectives.

Qualifications

·       MS in Chemistry, Pharmaceutics, or Engineering with at least 2-4 years of experience, or a Bachelor’s degree in Chemistry, Pharmaceutics, or Engineering with at least 3 years of experience in analytical chemistry in the pharmaceutical industry.

·       Experience with the following analytical techniques is highly desirable:

o   HPLC, GC, MS, DSC, TGA, Particle Size and Microscopy in the analysis of Active Pharmaceutical Ingredients

·       MS, GC, HPLC, wet chemistry techniques for pharmaceutical products

·       Experience with Empower data analysis software is desirable

·       Must be able to perform compendia and non-compendia testing for multiple projects at a time

·       Knowledge of the critical functions/variables for each type of equipment as well as instrument troubleshooting ability

·       Knowledge of current FDA/ICH guidance and national Pharmacopeias is required

·       Knowledge of the critical functions/variables for each type of equipment as well as instrument troubleshooting ability

·       Must be able to work independently using a team approach to accomplish tasks assigned, Must possess the ability to work on multiple projects in a fast-paced environment

·       Apply GMP/GLP in all areas of responsibility as applicable

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm.  Candidates currently living within a commutable distance of Columbus, OH are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

EUROFINS IS A M/F, DISABLED, AND VETERAN EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.