Fresenius Kabi USA, LLC
Scientist, Analytical Development
Fresenius Kabi USA, LLC, Chicago, Illinois, United States, 60290
Job Summary The Scientist, Analytical Development conducts all aspects of Analytical Development including method development, experimentation, and record keeping. The Scientist, Analytical Development must be able to develop and implement methods that meet project needs. The position is responsible for conducting analytical development studies with increasing complexity in nature and solving problems to ensure a robust method can be performed in the laboratory.
*This position requires working onsite at our Melrose Park, IL R&D facility. *Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (e.g., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.
*Salary Range: $65,000- $75,000 *Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. *Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Responsibilities
Accept responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing, etc. Perform validations or verification of methods including transfer of methods to Quality Technologies or Quality Control or other testing laboratory. Review and approve Validation protocol/report, data packages, SOPs and other Laboratory documentation. Support Laboratory operation for instrument qualification. Ensure all technologies needed are available for project completion. Plan, develop, and implement scientifically well-designed experimental programs and demonstrate creativity and capability in analytical method development, validation, and testing. Identify problem areas and utilize scientific resources to recommend alternatives, priorities, and results to resolve problems. Accurately and completely record experimental procedures, test results, and observations to meet corporate and GMP requirements. Job Requirements: Bachelor's Degree in Chemistry or related degree with 3-5 years of related experience OR Master's Degree in Chemistry with 0-3 years of related experience. Experience in chromatographic analysis of large biological compounds is desired. Skills in analytical techniques, such as UHPLC, UPLC, HPLC, LCMS, GC, IC, FTIR, Karl Fischer (KF) Skills in handling wet chemistry and operating basic lab instruments Skills in designing and executing experiments using different lab instruments e.g. UHPLC, UPLC, HPLC, and GC Experience in analytical method development and validation is preferred Working knowledge of cGMP regulations is desired Familiar with concepts of pharmaceutical analytical operations including FDA and GMP regulations Knowledge of statistical analysis/interpretation, pharmaceutical dosage forms, as well as concepts in developing novel drug delivery systems Strong oral and written communication skills; strong interpersonal skills Eye for detail and repetitive precision in lab work and documentation 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 contribution , andwellness 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.
Helping all candidates find great careers is our goal. The information you provide here is secure and confidential. We are now directing you to the original job posting. Please apply directly for this job at the employer’s website.
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*This position requires working onsite at our Melrose Park, IL R&D facility. *Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (e.g., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.
*Salary Range: $65,000- $75,000 *Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. *Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Responsibilities
Accept responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing, etc. Perform validations or verification of methods including transfer of methods to Quality Technologies or Quality Control or other testing laboratory. Review and approve Validation protocol/report, data packages, SOPs and other Laboratory documentation. Support Laboratory operation for instrument qualification. Ensure all technologies needed are available for project completion. Plan, develop, and implement scientifically well-designed experimental programs and demonstrate creativity and capability in analytical method development, validation, and testing. Identify problem areas and utilize scientific resources to recommend alternatives, priorities, and results to resolve problems. Accurately and completely record experimental procedures, test results, and observations to meet corporate and GMP requirements. Job Requirements: Bachelor's Degree in Chemistry or related degree with 3-5 years of related experience OR Master's Degree in Chemistry with 0-3 years of related experience. Experience in chromatographic analysis of large biological compounds is desired. Skills in analytical techniques, such as UHPLC, UPLC, HPLC, LCMS, GC, IC, FTIR, Karl Fischer (KF) Skills in handling wet chemistry and operating basic lab instruments Skills in designing and executing experiments using different lab instruments e.g. UHPLC, UPLC, HPLC, and GC Experience in analytical method development and validation is preferred Working knowledge of cGMP regulations is desired Familiar with concepts of pharmaceutical analytical operations including FDA and GMP regulations Knowledge of statistical analysis/interpretation, pharmaceutical dosage forms, as well as concepts in developing novel drug delivery systems Strong oral and written communication skills; strong interpersonal skills Eye for detail and repetitive precision in lab work and documentation 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 contribution , andwellness 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.
Helping all candidates find great careers is our goal. The information you provide here is secure and confidential. We are now directing you to the original job posting. Please apply directly for this job at the employer’s website.
#J-18808-Ljbffr