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Scientist (Formulation Development)

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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.

Average salary estimate

$72500 / YEARLY (est.)

min

max

$60000K

$85000K

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What You Should Know About Scientist (Formulation Development), Fresenius Global

If you're passionate about science and excited to make a real difference in the pharmaceutical world, the Scientist (Formulation Development) position at Fresenius Kabi in Melrose Park, IL, could be your next great opportunity! This role is all about taking the lead in formulation and process development studies, which are essential for ensuring that our products meet the FDA's high standards for stability data. You'll have the chance to work on-site at our innovative Development Center, where your contributions will directly impact our manufacturing processes. As a Scientist, you'll be responsible for every step of product development, from monitoring stability lot manufacturing to designing and executing experiments that push the boundaries of current practices. Your analytical skills will come into play as you evaluate test results and develop creative solutions to complex problems. Along the way, you'll document your findings to ensure compliance with corporate and GMP standards while supporting our manufacturing, quality assurance, and marketing teams. A Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Biological Sciences is required, along with at least a year of related experience or a Master's degree. If you have a knack for designing experiments and are well-versed in FDA regulations, we want to hear from you! Join us, and you'll enjoy not only a competitive salary but also a comprehensive benefits package, including health coverage and a 401K with company contributions, ensuring that you and your future are well taken care of.

Frequently Asked Questions (FAQs) for Scientist (Formulation Development) Role at Fresenius Global

What are the responsibilities of a Scientist (Formulation Development) at Fresenius Kabi?

As a Scientist (Formulation Development) at Fresenius Kabi, you're entrusted with a variety of responsibilities including overseeing every stage of product development, initiating well-designed experimental programs with minimal guidance, and monitoring the stability lot manufacturing processes. You'll evaluate and interpret test results, propose innovative solutions to address complex challenges, and ensure all actions meet corporate and GMP standards. Additionally, you'll write CMC documents for regulatory submissions and manage project timelines effectively.