Job Summary

Reports to Manager, QC Chemistry Technical Services
The Method Transfer Scientist is responsible for:
• Method transfers/method verifications/Co-Validations of compendial and non-compendial analytical methods utilized across Fresenius Kabi according to written procedures.
• Testing of routine and non-routine samples where specialized training is essential.
• Providing technical expertise and leadership.
• The position also requires a broad knowledge of analytical chemistry, pharmaceutical development, and regulatory requirements.

Compensation - $29.00 - $32.50/hour

Responsibilities

· Performs Method Transfers/method verifications/Co-Validations of testing procedures utilized within the Quality control Laboratory.

· Prepares testing documentation or progress reports on projects and recommends course of future action.

· Acts as liaison between the Product Development, Stability, and the QC Chemistry Laboratories for the transfer and implementation of new procedures.

· Investigates complex problems occurring in the Analytical Laboratories and report results as necessary.

· Provides leadership and expertise as required in projects where of troubleshooting of analytical methods and instrumentation is required.

· Accomplished scientist with relevant experience in the following activities; product development, and/or QC analytical laboratory

REQUIREMENTS

· Extensive knowledge of analytical chemistry as well as concepts in developing and validating methods to correct pharmaceutical standards.

· Working knowledge of GMPs, GLP, ICH, and USP guidance’s and regulations.

· Possess skills to analyze analytical results and solve problems.

· Prepares documentation for Regulatory Submissions as required.

· Reviews/Approves/Updates documentation such as Protocols, Test Methods, SOP’s, Specifications, ANDA submissions, etc.

· Strong interpersonal skills and highly effective in team settings.

· Strong project management skills, written, and oral communication skills.

· Must have a Ph.D., or a MS or BS with three years or more related experience, or High school Diploma with ten years experience.

· Excellent written and oral communication skills are required

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.