R&D Specialist, Stability

Medline • Mundelein, IL

5d

About The Position

The R&D Specialist will work with internal business partners and product development teams to provide stability support. This role is responsible for writing stability protocols/reports, evaluating stability data, performing risk assessment, and supporting process improvements. This position plays a critical role in setting expiration dates for medical devices, drugs, and cosmetics.

Requirements

• Bachelor of Science in Chemistry, Biology or related field.
• At least 2 years of experience in a medical device or pharmaceutical related field.
• Knowledge of FDA requirements and experience with FDA interactions as part of the 510k/ANDA/NDA approval processes.
• Knowledge of CE technical files.
• Experience with risk assessment and root cause analysis.
• Experience solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists.
• Experience communicating with internal and external business partners and cross functional teams with various audiences.
• Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem solving skills.
• Position may require travel up to 10% of the time for business purposes (domestic and international).

Nice To Haves

• Experience with stability studies for drugs and/or medical devices in a regulated environment.
• Knowledgeable of stability requirements for drugs and medical devices
• Protocol/Report and LIMS experience

Responsibilities

• Direct stability studies required in support of product claims.
• Determine the tests and acceptance criteria required for stability in collaboration with testing subject matter experts and product divisions.
• Support new product development and provide stability requirements.
• Author and review test stability protocols and reports.
• Evaluate and trend stability data.
• Compile technical justifications and data summaries in support of stability claims.
• Ensure compliance of all data collection activities with applicable regulatory requirements.
• Participate in the support of internal and external audits.
• Support process improvement, deviations, CAPA, and OOS investigations.

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees