Job Summary

The Scientist (Formulation Development) is responsible for completing formulation and process development studies and to ensure that products can be manufactured to generate acceptable stability data for FDA drug application.

*This position requires working onsite at our Melrose Park, IL Innovation & Development Center.

Responsibilities

• Accepts responsibility for all stages of product development including on-site monitoring of stability lot manufacturing.
• Plans, develops and implements scientifically well designed experimental program with minimal direction and guidance.
• Identifies the multidimensional aspects of complex problems and applies novel and creative solutions to problems. Capable of handling the most complex projects with only general guidance.
• Evaluates and interprets test results associated with project objectives. Analyzes causes of variances and develops alternate courses of action to achieve desired goals.
• Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements.
• Aids in providing technical service and product information for the support of manufacturing quality assurance, medical information and marketing.
• Identifies critical process parameters and process control for scale up of the manufacturing process and transfers the technology accurately to the plant
• Write Chemistry, Manufacturing and Control (CMC) document for Regulatory submission
• Establishes work priorities for assignments within their authority and keeps assignment completion on schedule.
• Responsible for providing data and scientific justifications for responding to FDA review comments.

Job Requirements

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Biological Sciences with 1+ year of related experience -OR- Master's degree in Pharmaceutical Sciences, Chemistry, or Biological Sciences
• Must have skills in designing and executing experiments using different lab instruments
• Must be familiar with concepts of pharmaceutical industry operations including FDA regulations
• Must be willing to perform drug product development for potent compounds, cytotoxic substances and/or controlled substances while following and observing all safety procedures in place, which include the use of engineering controls, administrative controls, Standard Operating Procedures (SOPs), training and Personal Protective Equipment (PPE)

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.