R&D Specialist-Stability

R&D Specialist-Stability

W2 Contract-to-Hire

Salary Range: $62,400 - $83,200 per year

Location: Mundelein, IL - Hybrid Role

Job Summary:

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.

Duties and Responsibilities:

• Direct stability studies are 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.

Requirements and Qualifications:

• Bachelor of Science in Chemistry, Biology, or related field.
• At least 2 years of experience in a medical device or pharmaceutical-related field.
• Knowledge / Skills / Abilities
• 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).

Preferred Qualifications:

• 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

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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