Senior Research Associate, Medical Device R&D & Scale-Up

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

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,