Research Associate Scientific III

Duration: 12 Months Contract (Extension Possible)
Description:

• 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.

• 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 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.

• 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