R&D Specialist-Stability

This range is provided by Bayside Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$30.00/hr - $40.00/hr

R&D Specialist-Stability

W2 Contract-to-Hire

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

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

Desired Skills and Experience

Stability studies, product stability support, stability protocol authoring, stability report writing, stability data evaluation and trending, expiration date determination, risk assessment, root cause analysis, CAPA support, OOS investigations, deviation management, regulatory compliance, FDA regulations, FDA interactions, 510(k) submissions, ANDA submissions, NDA submissions, CE technical files, medical device stability, pharmaceutical stability, drug stability requirements, medical device stability requirements, new product development support, acceptance criteria definition, test method selection, technical justifications, data summaries, process improvement, internal audits, external audits, cross‑functional collaboration, stakeholder communication, LIMS, protocol development, report review, analytical problem solving, critical thinking, organizational skills

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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