Duration: 12+ months contract (Possible Extension)
Timing: 1st shift (Monday to Friday).
Pay rate: $50/- hourly on W2 with 5 PTO
Job 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.
Essential Duties and Responsibilities:
- The incumbent will perform other duties assigned.
- 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, can 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.
Job Requirements:
- 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.
- The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills.
An Ideal Candidate would have experience with:
- Knowledge/experience with lyophilization.
- Knowledge/experience with Class 2/ 510k/ PMA FDA approved medical devices.
Best regards,
Rachit Rastogi (Rick)