Research Associate

Spectraforce Technologies; Deerfield (IL); On-site; USD 65,000 - 95,000; Full time

Job summary

Spectraforce Technologies is seeking a Research Associate to contribute technical knowledge across biomaterials development and regulatory support in our Deerfield, IL site. The role requires hands-on laboratory work and collaboration with cross-functional teams to advance product development and scale-up.

Ideal candidates have a scientific degree and lab experience in GMP/QSR environments, familiarity with lyophilization, and comfort interpreting regulatory guidelines to ensure compliant

Qualifications

• Bachelor’s degree in a scientific discipline with lab experience (3–6 years) or MS with 1–2 years experience.
• Experience in GMP/QSR environments, cross-functional teamwork, and method development/validation.
• Knowledge of lyophilization and FDA device development processes.

Responsibilities

• Make technical recommendations and independently select procedures for routine projects.
• Execute routine assignments and identify improvements to existing methods.
• Maintain knowledge of QSR, safety, and regulatory requirements for compliant research activities.
• Scale up biomaterials from lab to production.
• Contribute to technical feasibility analyses of complex concepts.
• Monitor external testing budgets and timelines.
• Apply GxP knowledge to facilitate documentation and product registration.
• Analyze results and determine best solutions for non-routine problems.

Skills

GMP knowledge

Experimental design

Data analysis

Lyophilization

Regulatory awareness

Education

Bachelor’s degree in science

MS degree Adv. (optional)

Tools

Lab instruments

Job description

Position Title: Research Associate
Work Location: Deerfield IL 60015
Assignment Duration: 11 + months
Work Arrangement: Onsite

Position 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.

Background & Context:
The incumbent will perform research and development activities within our organization to support biomaterials development, product scale-up, and regulatory compliance.

Key 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 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 experiements 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.

Qualification & Experience

• 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