Research Associate

Position Title: Research Associate

Work Location: Deerfield IL 60015

Assignment Duration: 11 + months

Work Arrangement: Onsite

Position Summary:

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.

Background & Context:

The incumbent will perform research and development activities within our organization to support biomaterials development, product scale-up, and regulatory compliance.

Key Responsibilities:

* 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.

* Manufacturability/Scale Up of biomaterials- Transfer from lab scale experiements 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.

Qualification & Experience:

* The position requires relevant laboratory skills, writing skills, and computer skills plus 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.

* Knowledge/experience with lyophilization

* Knowledge/experience with Class 2/ 510k/ PMA FDA approved medical devices

* Medical Device Product development experience