Research Associate III

Stark Pharma Solutions Inc; Chicago (IL); On-site; USD 70,000 - 95,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking a Research Associate III in Illinois to independently conduct experiments, support method development, and contribute to biomaterial scale-up and product development activities within a regulated environment.

The candidate will work with R&D, Quality, Manufacturing, and Regulatory teams, maintain documentation, and ensure compliance with GxP and QSR requirements while supporting testing and data analysis across projects.

Qualifications

• 3–6 years of relevant laboratory or research experience with a Bachelor's degree in a scientific discipline.
• 1–2 years of experience with a Master's degree.
• Experience in GMP, GxP, QSR, or other regulated environments.
• Experience with independent experimentation, method development, or method validation.
• Knowledge of biomaterials and laboratory-to-manufacturing scale-up.

Responsibilities

• Conduct routine and non-routine research and design experiments with minimal assistance.
• Independently select appropriate techniques and procedures to solve technical problems.
• Provide technical recommendations for research and development projects.
• Analyze and improve experimental procedures and research methods.
• Identify alternative methods and technologies to improve products and processes.
• Support biomaterial manufacturability and scale-up from lab to manufacturing.
• Coordinate external testing, including communication, shipments, results, and documentation.
• Work with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory teams.
• Prepare and maintain technical documentation, reports, and research data.

Skills

Laboratory skills

Technical writing

Data analysis

Teamwork

GxP experience

Education

Bachelor's degree in a scientific discipline

Master's degree

Tools

Lyophilization

Job description

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

Research Associate III

Location

Illinois

Duration

Long Term

Job Overview

We are seeking a Research Associate III with strong laboratory and research experience in medical device or regulated product development. The ideal candidate will independently conduct experiments, support method development, and contribute to biomaterial scale-up and product development activities.

Key Responsibilities

• Conduct routine and non-routine research and design experiments with minimal assistance.
• Independently select appropriate techniques and procedures to solve technical problems.
• Provide technical recommendations for research and development projects.
• Analyze and improve experimental procedures and research methods.
• Identify alternative methods and technologies to improve products and processes.
• Support biomaterial manufacturability and scale-up from laboratory experiments to manufacturing production.
• Contribute to technical feasibility analysis of research and design concepts.
• Support method development and validation activities.
• Analyze experimental results for validity and compliance with specifications.
• Maintain compliance with GxP, QSR, safety, and applicable regulatory requirements.
• Coordinate external testing, including communication, shipments, results, and documentation.
• Work with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory teams.
• Prepare and maintain technical documentation, reports, and research data.

Required Qualifications

• 3 6 years of relevant laboratory or research experience with a Bachelor's degree in a scientific discipline, or 1 2 years with a Master's degree.
• Strong laboratory, technical writing, and computer skills.
• Experience working in GMP, GxP, QSR, or other regulated environments.
• Experience with independent experimentation, method development, or method validation.
• Knowledge of pH, temperature-controlled reactions, and chemical reactions.
• Experience with biomaterials and laboratory-to-manufacturing scale-up.
• Knowledge or experience with lyophilization.
• Knowledge or experience with Class II, 510(k), or PMA medical devices.
• Medical device product development experience.
• Strong analytical, problem-solving, and technical decision-making skills.
• Good communication, teamwork, and interpersonal skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.