Associate Research Scientist III

DivIHN Integration•Deerfield, IL

1d•Onsite

About The Position

This role involves contributing solid technical knowledge to various projects within a relevant discipline with minimal assistance. The incumbent will display a moderate technical understanding of related disciplines such as pH, temperature-controlled reactions, and chemical reactions. They will also conduct routine/non-routine research and design experiments with minimal assistance. Key responsibilities include making sound technical recommendations for routine matters, providing analysis/redesign of key experimental procedures, and independently selecting techniques and methods to solve problems. The role requires employing appropriate techniques to execute assignments within deadlines, identifying alternative methods for product/process improvement, and maintaining knowledge of relevant QSR and safety requirements, as well as other R&D-related regulatory requirements. Specific duties include the manufacturability/scale-up of biomaterials, transferring lab-scale experiments to manufacturing production, contributing to technical feasibility analysis of complex research and design concepts, and monitoring budgets and schedules for external testing. The position also requires an in-depth understanding of GxP and related regulations, the ability to provide expert insights into these regulations, and the application of technical theories and principles to non-routine tasks. The individual will analyze and determine solutions for non-routine experimental design or research problems and accurately assess results for validity and conformance to specifications.

Requirements

Relevant laboratory skills
Writing skills
Computer skills
Teamwork/interpersonal skills
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.
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.