Research Associate Scientific III

Job Description

Job 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.
• Conduct routine/non-routine research and design experiments with minimal assistance.

Duties and 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 the 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 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 to facilitate efficient product registration and/or participate in the generation, review, adoption, and interpretation of such regulations.
• Demonstrate ability to apply technical theories and principles to projects within the 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:

• 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.