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.
*Salary Range: $85,000-95,000
*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
- 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 with 5+ years of related experience; or a Master's Degree in Chemistry with 3+ years of related experience; or a PhD in Chemistry with 0-3 years of related experience is required.
- Skills in chromatography, such as HPLC, LCMS, LCMS-MS, GC, SEC-MALS, CD, NMR, and related techniques.
- Experience in analytical method development and validation for the Nitrosamine test by LCMS is preferred.
- Skills in designing and executing experiments using different lab instruments and techniques e.g. HPLC, LCMS and GC are required.
- Experience in amino acid analysis and total peptide content is preferred.
- Experience in the characterization and sequencing of peptides and assessing their properties, such as peptide aggregation and 2D/3D structures, is also preferred.
- Knowledge of statistical analysis/interpretation, pharmaceutical dosage forms, as well as concepts in developing novel drug delivery systems
- Familiar with concepts of pharmaceutical analytical operations including FDA and GMP regulations
- Strong oral and written communication skills
- Strong problem-solvingand 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.
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