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 assigned.
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:
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Knowledge/experience with lyophilization
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Knowledge/experience with Class 2/ 510k/ PMA FDA approved medical devices
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Medical Device Product development experience
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