The Position

The Sr Specialist, Stability QC is responsible for managing and enabling Arrowhead’s Quality Control stability program. Key responsibilities of this position include Reference Material Management and Sample Stability Testing and Management. The Sr Specialist, Stability QC is also responsible for maintaining study documentation, ensuring that study reports are complete and accurate, as well as performing stability testing. This position will communicate with contract vendors to coordinate analytical testing and sample storage and is responsible for the reconciliation and disposition of stability samples upon completion of studies.

Responsibilities: 

• Manage stability programs for various projects in commercial, preclinical and clinical development internally or at external parties.
• Author, review, and approve stability protocols; responsible for planning, execution, data management, data analysis, and data trending to support in-process, drug substance and drug product retest period/shelf-life determination.
• Create, implement, and manage stability databases, perform data trending and statistical analysis, study and test forecasting and reporting of metrics and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations.
• Manage Reference material program.
• Review raw data to support release testing, stability testing, and reference materials qualification.
• Escalate trends and support associated investigations, including temperature excursion assessment, client and regulatory requests.
• Summarize stability results by applying analytical testing expertise to ensure scientific and technical excellence. Utilize statistical software like JMP to perform statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards.
• Manages Quality Systems records for QC Stability-creates, assesses, reviews Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events.
• Assist in the coordination and management of contract labs and storage sites for the preparation and initiation of stability studies.
• Assist in the management of internal and external retain and reserve samples.
• Produce impactful PowerPoint presentations to effectively communicate stability data to diverse project team members. Support the attainment of project milestones by facilitating stability monitoring and determining expiration dates for clinical and in-process materials.
• Work cross-functionally to provide oversight of stability processes and improvements.
• Other projects (e.g., review method qualifications, specifications), as deemed appropriate.

Requirements:

• Bachelor’s degree in Life Sciences with 8 years’ relevant industry experience in the pharmaceuticals or biotechnology industry required.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, degradation pathways, accelerated stability testing, shelf-life determination, expiry dating, and analytical method qualification/validation.
• Proficient with ICH, cGLP and cGMP requirements for analytical techniques that include but are not limited to LC, GC, KF, UV-Vis, FT-IR, NMR, LCMS, compendial and microbiology methods.
• Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/ shelf-life proposals.
• Extensive technical writing experience.
• Experience with MS programs including Excel, Word, and PowerPoint.
• Strong verbal and written communication skills and ability to work in a cross-functional environment.
• Solid organizational skills with ability to adapt to changing priorities and deadlines.