Description:

12 months contract ; May extend Onsite 3 days at Deerfield ; 2 days in Round Lake IL 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.

Essential Duties and Responsibilities:

The incumbent will perform other duties assign ed. 1. 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. 2. 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. 3. 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. 4. Manufacturability/Scale Up of biomaterials- Transfer from lab scale experiements to manufacturing production. 5. Contribute to technical feasibility analysis of complex research and design concepts. 6. Monitor budgets and/or activity schedules of external testing (communication, shipment, analysis of results and documentation). 7. 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. 8. 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.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills. Education and/or

Experience:

Include the education and experience that is necessary to perform the job satisfactorily. 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. An Ideal Candidate would have experience with: Knowledge/experience with lyophilization Knowledge/experience with Class 2/ 510k/ PMA FDA approved medical devices Medical Device Product development experience