Research Associate

Stefanini North America and APAC; Deerfield (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

Stefanini Group is seeking a Research Associate in Deerfield, IL (Onsite) to contribute technical expertise across project workstreams. You will perform routine and non-routine experiments, ensure regulatory compliance, and support product development in a GMP/QSR environment.

The ideal candidate has a scientific degree and relevant lab experience, with strong writing and computer skills. This onsite role emphasizes collaboration, method development, and process scale-up from lab to production.

Qualifications

• Bachelor's degree in a scientific discipline with 3–6 years lab experience or MS with 1–2 years experience.
• GMP/QSR environment experience, cross-functional teamwork, and independent experimentation in method development and validation.
• Requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills.

Responsibilities

• With minimal assistance, make sound technical recommendations and independently select techniques to solve routine problems.
• Execute routine assignments using appropriate techniques and adherent to deadlines; explore alternative methods for improvements.
• Maintain knowledge of QSR/safety requirements and other regulatory guidance to ensure compliance in research and reporting.
• Scale-up biomaterials from lab to manufacturing; transfer knowledge to production environments.
• Contribute to technical feasibility analyses of complex concepts and monitor external testing budgets/schedules.
• Apply knowledge of GxP regulations to support product registration and regulatory insights.
• Analyze results for validity and conform to specifications when solving non-routine design or research problems.

Skills

Lyophilization

FDA Class 2/510k/PMAs

Medical Device product development

Education

Bachelor's degree in a scientific discipline

MS in a relevant field

Job description

Stefanini Group is hiring!

Stefanini is looking for Research Associate in Deerfield, IL (Onsite)

Work Hours: M-F (40 hours)

Work Location: Deerfield, IL

Shift: 1st Shift

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:

• 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, 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.

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.
• Medical Device Product development experience.

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.