Job Summary

This 3-year rotational program at Fresenius Kabi gives recent college graduates a unique opportunity to begin their careers gaining a holistic understanding of R&D functions via rotational work assignments. Research & Development Professional Development Program Associates will rotate through key Research & Development areas such as formulation development and analytical development. Research & Development Professional Development Program Associates leave the program with organizational knowledge and insights which are brought into a full-time role within Fresenius Kabi. The program offers the opportunity to immediately contribute to the business goals of each department taking on tasks and projects. As a Research & Development Professional Development Program Associates, you will discover your strengths and build upon the skills and knowledge acquired during your studies. Successful candidates will rotate through various departments up to 36 months.

Responsibilities include projects and assignments that support R&D departments of the US and/or Global businesses within Fresenius Kabi. These projects include, but are not limited to experiences with product development, extractable and leachable, stability testing, physico chemical testing, method development, and method validation.

*Qualified candidates must be permanently authorized to work in the U.S. This position is unable to accommodate current or future sponsorship (e.g., individuals on OPT do not qualify for this role).

Responsibilities

Completion of department rotations of 18 months each. Formulation Development rotations include experiences with extractable and leachable, product development and stability. Analytical Development rotations include physico chemical testing, method development, method validation and stability testing.  Responsibilities will vary upon each placement:

Formulation Development

• Extractable and Leachable (E/L):  Prepare E/L study protocols and reports.  Perform E/L test methods development and validation, samples testing, E/L compounds identification and toxicity assessment/justification, prepare CMC documents pertaining to E/L for Regulatrory submission.
• Product Development:  Conduct scientifically well-designed product development studies to identify stable formulation, manufacture processes, process control parameters, and product specifications.  Prepare technology transfer documents for process scale up to a production site.  Prepare relevant Chemistry, Manufacturing and Control (CMC) ducuments for Regulatory submission.
• Stability:  Prepare stability testing protocol, intiate the stability program, pull and submit stability samples, compile stability data summary, maintain compliance to cGMP requirements for ICH stability, and support relevant CMC documents pertaining to ICH stability.

Analytical Development

• Physico Chemical Testing: Skills in analytical techniques, such as Viscosity by Rheometer, FTIR, Karl Fischer (KF) and related techniques
• Method Development: Plans, develops, and implements scientifically well-designed experimental programs and demonstrates creativity and capability in analytical method development.
• Method Validation: Conduct scientifically well-designed analytical method validation studies using various analytical techniques such as Titrations, HPLC, GC. etc.  Knowledge of statistical analysis/interpretation, pharmaceutical dosage forms, as well as concepts in developing novel drug delivery systems.
• Stability Testing: Accurately and completely records experimental procedures, test results, and observations to meet corporate and GMP requirements. Familiar with concepts of pharmaceutical analytical operations including FDA and GMP regulations.
• Participates in any and all work activities as assigned by management.

Job Requirements

• Bachelor Degree required, preferably in Pharmaceutical Sciences, Chemistry or Chemical Engineering
• Ideal candidate will have recently graduated
• Preference is given to those candidates with internship experience
• Detailed and results-oriented with excellent communication and collaboration skills.
• Ability to quickly establish working relationships and effectively transition through assignments.
• The ability to work independently and interface with various levels of management in a multi-task, deadline oriented team environment.
• Excellent written and verbal communication skills.
• Demonstrated competencies aligned with Fresenius Kabi’s Core Values:  Customer Focus, Quality, Integrity, Collaboration, Creativity, Passion and Commitment.
• Ability to maintain complete confidentiality and discretion