Stability Specialist II

How you’ll make an impact:

As a Stability Specialist II, you'll make an impact by originating stability protocols and reports, coordinate, review, trend, and report stability test data across our early and late phase oncology portfolio. 

About the team:

The Quality Control department is all about getting stuff done/working collaboratively.  Whether it’s making sure we deliver to our patients and clinics, or build for the future, we are driven by quality because time matters – we prioritize what matters most and do it with our patients in mind. Come work with a group of employees that loves rising to the challenge much as we do!  As a Stability Specialist, you'll help to bring more patients more TIME.

How you’ll spend your time:

• Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for ancillary materials, starting materials and clinical drug product
• Contribute to a risk-based stability program for ancillary materials, starting materials, and drug products in support of early, late-phase clinical and commercial products
• Utilize statistical software to trend stability data and establish retest and expiration dates
• Performing stability pulls and stability sample inventory if needed
• Owning, writing, investigation, and tracking Stability QMS items
• Trending data across the shelf-life multiple products
• Collaborate on multiple projects across multiple departments
• Oversee cross-functional laboratory investigations related to stability and laboratory operations
• Collaborate with Quality management and CTOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
• Assis with CMC stability sections for clinical regulatory filings, MAA, and BLA

Who you are and what you’ve accomplished:

• Have BS/BA in Biology, Chemistry, or equivalent with 6+ years, MS with 3+ years of related experience cGMP laboratory / environment, knowledge of: cGMPs, USP, and FDA regulations related to stability program
• Are experienced in authoring stability protocols, data review, compile data into stability reports and trend the data over the shelf-life of products, Identify and report any out of trend or out of specification data
• Are familiar with Veeva, JMP, Microsoft Office
• Experience in cell culture, bioassay, flow cytometry, quantitative PCR, and other bioanalytical methods such as ELISA and HPLC methods preferred
• Demonstrate a strong initiative and scientific leadership
• Have excellent collaboration, communication, and organizational skills
• Work style qualification: ability to multitask and work under minimal supervision, highly motivated who fosters teamwork
• Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude