Scientist

Fresenius Kabi; Melrose Park (IL); On-site; USD 70,000 - 75,000; Full time

Benefits offered by this job

401(k) with company contributions

Health, dental and vision coverage

Paid vacation, holidays and personal/s

Employee assistance program

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a Scientist, Analytical Development to lead method development, validation, and stability studies in a GMP environment. You will develop robust analytical methods and ensure accurate documentation and data integrity across all projects.

The role requires expertise in chromatography techniques (HPLC/GC/TLC/IC), wet chemistry, and instrumental analysis, with strong problem-solving and communication skills.

Qualifications

• BS degree in Chemistry or related field with 3+ years of relevant experience.
• Experience with analytical method development, validation and transfer.
• Strong understanding of GMP/QA regulations and pharmaceutical analytics.

Responsibilities

• Develop, validate, and transfer analytical methods (HPLC/GC/TLC/IC) as required.
• Review validation protocols/reports and lab documentation for accuracy and compliance.
• Plan and execute stability testing, generate COA summaries, and coordinate with Regulatory Affairs.
• Support instrument qualification and ensure availability of lab technologies for project completion.
• Document experimental procedures and results with precision and traceability.

Skills

Chromatography

Wet chemistry

Instrument handling

Statistical analysis

English proficiency

Education

Bachelor of Science in Chemistry

Tools

FTIR

Karl Fischer

Osmometer

Colorimeter

UV/Vis

HIAC

Job description

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 projectneeds. The position is responsible for conducting analytical development studies with increasing complexity in nature andsolving problems to ensure a robust method can be performed in the laboratory.Salary Range: $70,000-75,000Final 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.ResponsibilitiesAccepts 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.Requirements :BS degree in Chemistry or related degree with 3+ years of related experienceMust possess skills in chromatography, such as HPLC, GC, TLC, IC and/or skills in handling wet chemistry and operating basic lab instruments, such as pH, Osmometer, Colorimeter, HIAC, particle size analyzers, FTIR, Karl Fischer methods 1a and 1c, UV/Vis, specific rotation, residue on ignition, manual titrations, loss on drying, etc.Must have skills in designing and executing experiments using different lab instruments 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.Strong problem-solving skills.Strong interpersonal skills.The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.Additional InformationWe 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.Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.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.