Stability Scientist II

Job Description

Job Summary:

• The Engineer/Scientist II, Quality Assurance – Stability executes and manages stability studies supporting new product introductions (NPI), commercial products, and product shelf-life claims.
• This role manages assigned studies throughout the stability lifecycle, including sample management, scheduled pulls, laboratory testing, data review and trending, investigations, documentation, and reporting.
• The position partners cross-functionally to ensure accurate, traceable, and timely stability evidence is available to support product commercialization, regulatory submissions, ongoing market support, and IVDR compliance.

Duties and Responsibilities:

• Execute and independently manage assigned stability studies in accordance with approved protocols, procedures, methods, and specifications.
• Coordinate study initiation, sample placement and inventory, scheduled pulls, testing, data review, reporting, and study completion.
• Perform and/or coordinate laboratory testing and ensure stability activities and documentation are completed according to established timelines.
• Compile, review, analyze, and trend stability data; identify and escalate unexpected results, adverse trends, and potential product-quality concerns.
• Prepare and maintain stability study records, data summaries, and interim/final technical reports that are accurate, traceable, and inspection-ready.
• Support NPI and product lifecycle projects, including stability requirements, schedules, sample needs, deliverables, and generation of evidence supporting shelf-life claims.
• Execute ongoing stability activities for commercial products and evaluate stability data associated with product, manufacturing, packaging, formulation, or process changes.
• Provide stability data and documentation supporting regulatory submissions, product registrations, IVDR technical documentation, audits, and inspections.
• Support investigations involving deviations, unexpected results, missed time points, sample issues, nonconformances, and CAPAs.
• Partner with R&D, Regulatory Affairs, Quality, QC, Operations/Manufacturing, and Product/Project Management to meet stability, NPI, commercial, and regulatory deliverables.
• Identify opportunities to improve and standardize stability processes, workflows, metrics, documentation, and study-management tools.

Education:

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Biotechnology, Chemical Engineering, Biomedical Engineering, or a related scientific/technical discipline required.
• Advanced degree in a relevant discipline preferred.

Experience:

• Typically 2–5 years of relevant laboratory, Quality Control, analytical, product-development, or related experience in a regulated environment.
• Experience in IVD, medical devices, pharmaceuticals, biotechnology, or another regulated life-sciences environment preferred.
• Experience executing stability studies/testing and supporting regulated product development or commercial products strongly preferred.

Knowledge, Skills & Abilities:

• Working knowledge of laboratory testing, Good Documentation Practices, and Quality Management Systems.
• Ability to independently organize and manage multiple studies, samples, time points, testing requirements, and priorities.
• Ability to review, trend, and interpret scientific data and recognize potential product-quality concerns.
• Strong technical writing, analytical, critical-thinking, problem-solving, organizational, and communication skills.
• Strong attention to detail and commitment to data accuracy and integrity.
• Proficiency with Microsoft Excel, Word, and applicable laboratory/Quality systems.
• Knowledge of statistical techniques for stability analysis and experience supporting IVDR-regulated products preferred.

Physical Requirements / Work Environment:

Controlled Substance Handling:

• This role involves the handling, management, and oversight of controlled substances.
• The role will be responsible for ensuring compliance with all relevant regulations and guidelines on controlled substances.

Exposure to Controlled Substances:

• The role may be exposed to controlled substances during their duties.
• Proper safety protocols and protective measures will be provided and must be strictly followed.

Safety Protocols:

• Ability to adhere to strict safety protocols and procedures to ensure a safe working environment.

Background Check:

• Successful completion of a background check, including screening for any history related to controlled substances.