Stability Scientist II

TekWissen • Fremont, CA

1d • Onsite

About The Position

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Biology, Biotechnology, Chemical Engineering, Biomedical Engineering, or a related scientific/technical discipline required; advanced degree preferred.
• 2–5 years of relevant laboratory, Quality Control, analytical, product development, stability, or related experience in a regulated environment.
• Experience in IVD, medical devices, pharmaceuticals, biotechnology, or another regulated life-sciences environment.
• Experience executing stability studies/testing and supporting regulated product development or commercial products strongly preferred.
• Working knowledge of laboratory testing, Good Documentation Practices (GDP), and Quality Management Systems (QMS).
• Experience managing stability studies, samples, scheduled time points, testing requirements, and study documentation.
• Experience reviewing, analyzing, trending, and interpreting scientific/stability data.
• Knowledge of statistical techniques used for stability analysis preferred.
• Experience supporting IVDR-regulated products preferred.
• Proficiency with Microsoft Excel, Word, and applicable laboratory/Quality systems.
• Experience supporting deviations, investigations, nonconformances, CAPAs, or unexpected stability results preferred.
• Knowledge of controlled substance handling requirements and applicable safety procedures.

Nice To Haves

• advanced degree preferred
• Experience executing stability studies/testing and supporting regulated product development or commercial products strongly preferred
• Knowledge of statistical techniques used for stability analysis preferred
• Experience supporting IVDR-regulated products preferred
• Experience supporting deviations, investigations, nonconformances, CAPAs, or unexpected stability results preferred

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 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.
• Handle, manage, and oversee controlled substances in compliance with applicable regulations and guidelines.
• Follow established safety protocols and procedures when working with or exposed to controlled substances.

What This Job Offers

• Career Level: Mid Level