R&D Scientist

Stefanini Group•Deerfield, IL

18h•Onsite

About The Position

Stefanini Group is hiring! Stefanini is looking for an R&D Scientist in Deerfield, IL (Onsite). This role effectively contributes solid technical knowledge to a variety of projects within the relevant discipline with minimal assistance. The incumbent will display moderate technical understanding of related disciplines such as pH, temperature controlled reactions, and chemical reactions. They will conduct routine/non-routine research and design experiments with minimal assistance. The incumbent will perform other duties assigned. Without assistance, make sound technical recommendations regarding projects/matters that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility. Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines. Identify existing alternative methods and technologies for improving existing or new products/processes. Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities. This role involves the manufacturability/scale-up of biomaterials, transferring from lab scale experiments to manufacturing production. Contribute to technical feasibility analysis of complex research and design concepts. Monitor budgets and/or activity schedules of external testing (communication, shipment, analysis of results and documentation). In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations. Demonstrate ability to apply technical theories and principles to projects within area of expertise for non-routine tasks. Analyze and determine best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications.

Requirements

Bachelor's Degree in a scientific discipline with at least 3-6 years lab experience or MS with at least 1-2 years of experience.
Relevant laboratory skills.
Writing skills.
Computer skills.
Teamwork/interpersonal skills.
Research lab experience may include research in GMP/QSR environment, cross-functional teamwork, and independent experimentation in method development and validation.

Nice To Haves

Knowledge/experience with lyophilization.
Knowledge/experience with Class 2/ 510k/ PMA FDA approved medical devices.
Medical Device Product development experience.

Responsibilities

Effectively contribute solid technical knowledge to a variety of projects within the relevant discipline with minimal assistance.
Display moderate technical understanding of related disciplines such as pH, temperature controlled reactions, and chemical reactions.
Conduct routine/non-routine research and design experiments with minimal assistance.
Make sound technical recommendations regarding projects/matters that are more routine than not.
Provide some analysis/redesign of key experimental procedures.
Independently select techniques and procedures to solve problems within area of responsibility.
Employ appropriate techniques/methods to successfully and independently execute routine assignments within negotiated deadlines.
Identify existing alternative methods and technologies for improving existing or new products/processes.
Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
Manufacturability/Scale Up of biomaterials- Transfer from lab scale experiments to manufacturing production.
Contribute to technical feasibility analysis of complex research and design concepts.
Monitor budgets and/or activity schedules of external testing (communication, shipment, analysis of results and documentation).
Provide expert insights into GxP and related regulations and guidance to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
Demonstrate ability to apply technical theories and principles to projects within area of expertise for non-routine tasks.
Analyze and determine best solutions to non-routine experimental design or research problems with minimal assistance.
Accurately assess results for validity and conformance to specifications.