Research Associate III

Stark Pharma Solutions Inc; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

Stark Pharma Solutions Inc. in Illinois seeks a Research Associate III with strong laboratory and research experience in medical device development and regulated product processes.

You will independently run experiments, support method development, and contribute to biomaterial scale-up and product development activities. The role requires rigorous adherence to GMP/GxP/QSR and related regulatory requirements, coordination of external testing, and collaboration with R&D, Quality, Manufacturing,

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.

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.

Skills

Laboratory skills

Technical writing

Computer skills

Regulated environments

Method development

Method validation

Lyophilization

Biomaterials

Scale-up

Medical devices knowledge

Medical device development

Analytical skills

Problem-solving

Decision-making

Communication

Teamwork

Interpersonal skills

Education

Bachelor's degree in a scientific discipline

Master's degree

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.