Stability Chemist

Job Title: Stability Chemist
Job Description

The Stability Chemist executes and manages stability studies in a GMP-regulated pharmaceutical environment to ensure product quality and shelf-life. This role focuses on analytical testing, trend analysis, and strict compliance with regulatory standards, supporting the full product lifecycle from development through commercialization. The position offers significant ownership of stability programs and the opportunity to deepen technical expertise while contributing to the continuous improvement of laboratory operations.

Responsibilities

• Lead and execute stability studies, including protocol design, sample testing, data review, and reporting.
• Develop stability protocols tailored to specific product characteristics and applicable regulatory requirements.
• Perform analytical testing using HPLC, FTIR, UV, and other relevant techniques to assess product stability.
• Conduct wet chemistry testing as part of comprehensive stability and quality assessments.
• Investigate out-of-trend (OOT) and out-of-specification (OOS) results, driving root cause analysis and implementing corrective actions.
• Document all experimental work and results in full compliance with cGMP and ALCOA+ principles.
• Support analytical method development, validation, and continuous improvement initiatives for stability testing.
• Assess packaging stability and compatibility, including evaluation of potential leachables and extractables.
• Coordinate day-to-day laboratory activities, including inventory management and equipment maintenance scheduling.
• Collaborate closely with QA, QC, and development teams to ensure product quality, regulatory compliance, and robust stability strategies.
• Contribute to the build-out and continuous improvement of laboratory processes, procedures, and standard operating procedures (SOPs).
• Support regulatory and product lifecycle requirements by providing stability data, documentation, and technical input.

Essential Skills

• . in Chemistry or a closely related scientific field.
• 2–4 years of experience in a pharmaceutical or analytical laboratory environment.
• Hands-on experience with stability programs in a GMP-regulated setting.
• Proficiency in HPLC for quantitative and qualitative analysis of pharmaceutical products.
• Experience performing stability testing and interpreting stability data and trends.
• Working knowledge of document control practices in a regulated pharmaceutical environment.
• Familiarity with cGMP and ALCOA+ principles for data integrity and documentation.
• Experience with FTIR and UV analytical techniques for stability and quality testing.
• Practical experience with wet chemistry techniques relevant to pharmaceutical analysis.
• Ability to investigate OOT and OOS results and support root cause analysis and corrective actions.
• Experience supporting method development and validation activities.
• Ability to work effectively with QA, QC, and development teams to ensure compliance and product quality.

Additional Skills & Qualifications

• Experience in the pharmaceutical industry with exposure to product lifecycle management.
• Familiarity with validation activities related to analytical methods and stability programs.
• Experience working with SOPs and contributing to the refinement of laboratory procedures.
• Ability to assess packaging stability, compatibility, and potential leachables or extractables.
• Strong organizational skills to coordinate laboratory activities, inventory, and equipment maintenance.
• Comfort working in a growing organization and contributing to the build-out and continuous improvement of laboratory operations.
• Strong communication skills for cross-functional collaboration and clear documentation.

Work Environment

This is an onsite, lab-based role in a GMP-regulated pharmaceutical environment. The Stability Chemist works hands-on with analytical instrumentation such as HPLC, FTIR, UV systems, and wet chemistry equipment. The position involves frequent collaboration with QA, QC, and development teams, supporting stability and regulatory requirements throughout the product lifecycle. The work setting emphasizes structured procedures, adherence to SOPs, and rigorous documentation standards, providing a dynamic environment where laboratory operations and processes continue to evolve and improve.

Job Type & Location

This is a Contract position based out of Mississauga, ON.

Pay and Benefits

The pay range for this position is $20.00 - $30.00/hr.

Workplace Type

This is a fully onsite position in Mississauga,ON.

À propos d'Actalent

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