Senior Scientist (Analytical Development)
Company
Fresenius Kabi
Location
Other US Location
Type
Full Time
Job Description
Job Summary
The Senior 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 research & development site.
*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.
Responsibilities
- All aspects of Analytical Development including transfer to Quality Technologies or Quality Control or other testing laboratory.
- 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.
- Reviews and approves Validation protocol/report, data packages, SOPs and other Laboratory documentation.
- Establishes work priorities for assignments within his/her authority and keeps assignment completion on schedule.
- Supports Laboratory operation for instrument qualification.
Job Requirements:
- Bachelor’s Degree in Chemistry or related degree with 5+ years of related experience; OR Master of Science Degree in Chemistry with 3+ years of related experience; OR PhD with 0-3 years of related experience.
- Skills in chromatography, such as HPLC, GC, TLC, IC.
- Skills in handling wet chemistry and operating basic lab instruments.
- Must possess skills in biochemical or molecular/cellular biology, such as cell based assay, enzymatic assay, aseptic and cell cultures (suspension and attached) techniques, and operating basic lab instruments. May require experience in HPLC, ELISA and SDS-PAGE.
- Must have skills in designing and executing experiments using different lab instruments (including HPLC) and techniques.
- Must have knowledge of statistical analysis/interpretation, pharmaceutical dosage forms, as well as concepts in developing novel drug delivery systems.
- Must be familiar with concepts of pharmaceutical analytical operations including FDA and GMP regulations.
- Strong verbal and written communication skills.
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, 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.
Date Posted
12/06/2024
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