Scientist, Analytical Development

Fresenius Kabi USA, LLC
$65,000- $75,000
life insurance, 401(k)
United States, Illinois, Lake Zurich
3 Corporate Drive (Show on map)
Mar 07, 2025
Job SummaryThe Scientist, Analytical Development conducts all aspects of Analytical Development including method development, experimentation, and record keeping. The incumbent 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. Read more about our benefits here. Responsibilities Accepts responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing, etc. Performs 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. Manages stability program by execution of stability testing protocols, testing logistics for laboratory, providing stability summaries, finished product COA generation and provides updates to Regulatory Affairs and project team. Support Laboratory operation for instrument qualification. Ensures all technologies needed are available for project completion. Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in analytical method development, validation, and testing. Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results to resolve problems. Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements. Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule. Requires an eye for detail and repetitive precision in lab work and documentation. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities Requirements* BS degree in Chemistry or related field and 3-5 years of related experience or MS Degree 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 Strong problem-solving 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.