Scientist

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

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL is seeking a Scientist, Analytical Development to lead method development, experimentation, and record keeping. The role focuses on developing and implementing robust analytical methods to meet project needs and ensure reliable laboratory performance.

The position requires a BS in Chemistry or related field with 3+ years of experience, strong chromatography skills, and knowledge of GMP/FDA regulations.

Qualifications

• BS degree in Chemistry or related field with 3+ years of experience.
• Experience with chromatography techniques (HPLC, GC, TLC, IC).
• Experience designing and executing experiments using lab instruments.
• Knowledge of statistical analysis and pharmaceutical dosage forms.
• Familiarity with FDA and GMP regulations.
• Strong written and verbal communication skills.

Responsibilities

• Accepts responsibility for all aspects of Analytical Development, including raw material release, stability, and formulation testing.
• Performs validations or verifications of methods including transfer of methods to other testing laboratories.
• Review and approve validation protocol/report, data packages, SOPs and other laboratory documentation.
• Manage stability program by execution of stability testing protocols and providing updates to Regulatory Affairs.
• Support Laboratory operation for instrument qualification.
• Ensure all technologies needed are available for project completion.
• Plan, develop, and implement scientifically designed experimental programs for method development and testing.
• Identify problem areas and propose alternatives and priorities to resolve problems.
• Accurately record experimental procedures, results, and observations to meet GMP requirements.

Skills

Chromatography techniques

Statistical analysis

Problem-solving

Strong communication

English proficiency

Education

Bachelor's degree in Chemistry or related field

3+ years related experience

Tools

HPLC

GC

TLC

IC

FTIR

Karl Fischer

Job description

Job Summary

The 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.

Salary Range: $70,000-75,000

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

• Accepts responsibility for all aspects of Analytical Development, including raw material release, stability, andformulation testing, etc.
• Performs validations or verification of methods including transfer of methods to Quality Technologies or QualityControl 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, providingstability summaries, finished product COA generation and provides updates to Regulatory Affairs and projectteam.
• 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 creativityand capability in analytical method development, validation, and testing.
• Identifies problem areas and utilizes scientific resources to recommend alternatives, priorities, and results toresolve problems.
• Accurately and completely records experimental procedures, test results, and observations to meet corporate andGMP 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 experience
• Must 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 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.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, 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.