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Senior Scientist, Formulation Development

Senior Scientist, Formulation Development

Fresenius Kabi USA, LLCLake Zurich, IL, United States
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Job Summary

The Senior Scientist is responsible for conducting development studies with increasing complexity in nature and solving problems to ensure a stable product can be manufactured in the production facility.

  • This position requires working onsite at our Innovation and Development Center in Melrose Park, IL.
  • This position is not eligible for sponsorship either now or in the future.
  • Salary Range : $85,000-100,000
  • Position is eligible to participate in an annual bonus plan with a target of 6% of the base salary.
  • 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 stages of product development including on-site monitoring of stability lot manufacturing.
  • Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in pharmaceutical research and development.
  • 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.
  • Scales up the manufacturing process and transfers the technology accurately to the production plant.
  • Sets product specifications based on stability results and according to FDA and ICH guidelines.
  • Writes Chemistry, Manufacturing and Control (CMC) section for Regulatory submission.
  • Responsible for product and process improvement as well as for ideas for new products, line-extent, product stability improvement and novel drug delivery systems.
  • Establishes work priorities for assignments within his / her authority and keeps assignment completion on schedule.
  • Job Requirements :

  • Bachelor's Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5+ years of related experience; or a Master's Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 3 years of related experience; or a PhD in Pharmaceutical Sciences, Chemistry, Biological Sciences, Chemical / Biomedical Engineering with 0-3 years of related experience is required.
  • Must possess skills of designing and executing experiments using different lab instruments and techniques.
  • Must have knowledge of statistic and analysis / interpretation, and pharmaceutical dosage forms. Experience in developing novel drug delivery systems is a plus.
  • 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).
  • Must be willing to travel domestically and internationally to production plant to support batch manufacturing, etc.
  • 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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    Scientist Formulation • Lake Zurich, IL, United States