Research Associate
VIVA
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.
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 VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
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