Manager, CMC Stability Management and Analysis

Immunome, Inc.•Bothell, WA

17h

About The Position

We are seeking a highly motivated and experienced Manager of CMC Stability Management and Analysis to join our team. This individual will lead the implementation and management of small molecule CMC stability programs at Immunome, for varegacestat, our lead compound nearing NDA submission. This individual will also perform statistical analysis, trending analysis as well as managing stability database. The incumbent will interpret and present stability data to all stake holder on a routine basis.

Requirements

BS in Analytical Chemistry or related discipline with a minimum of 5+ years’ experience in pharmaceutical/ biotechnology industry or MS with 3+ years of experience in the pharmaceutical/ biotechnology industry.
A minimum of 2 years of experience managing stability programs, preferably including late stage clinical/commercial programs.
Experience working with and managing third party vendors for stability programs.
Experience in Database and Information Management, SlimStat, Statistical Analysis and Reporting, and Analytical Method Development and Control.
Thorough knowledge of GLPs and GMPs as they relate to stability management.
Expertise with statistical analysis software, interpretation of analytical data, ability to draw conclusions and strong understanding of current analytical methodologies.
Able to present data to stakeholders or decision makers in the most informative/effective format.

Responsibilities

Lead the Stability database strategic and operational planning.
Collaborate with analytical laboratories managing all stability studies.
Manage the implementation, monitoring, maintenance and upgrade of the stability database.
Maintain a data collection plan and statistical methods to evaluate stability, product performance, shelf-life projections and trend analysis.
Maintain a Database that supports the entire life-cycle of a product from development to commercialization.
Perform statistical analysis of stability data to support effective, well-informed, data-driven decision making.
Interpret and present stability data to team leaders, regulatory bodies and other stakeholders in a comprehensive format as required.
Manage reference standard and reference material program(s)
Write and/or review stability reports and technical development reports
Manage, conduct or support investigations, change controls and CAPAs related to stability samples.
Prepare and assist in the preparation of regulatory submissions.