Skills

Accountable for end-to-end sample management of over 250 active clinical stability studies 

Set up stability studies for clinical products in accordance with internal PQS and ICH stability guidelines, schedule, build and execute new stability study initiations to ensure regulatory submission timelines are met, balance the workload for the current staff, and meet department goals and metrics 

Schedule and execute stability time point pulls, support the review and approval of time point data to follow regulatory compliance 

Author and edit documentation for Stability Protocols, Time Point Approval Memos, Study Termination Memos, CSARs and other compliance documents 

Follow all relevant documentation and edit as necessary to aid in continuous improvement 

Ensure data integrity and the principles of ALCOA+ to keep patients safe 

Use documentation systems such as Veeva/Phoenix, Labware LIMS, Single LIMS, Next Lab, ELN, SharePoint, SPECA, and MDMS to track sample information and manufacturing information

Strong technical and hands-on lab skills 

Maintain inspection ready labs through weekly lab sweeps to help maintain product safety 

Test assays including visible particulates, clarity and opalescence, pH and protein concentration by Slope Spectroscopy and have a theoretical understanding of PCR and Common HPLCs (SEC, IEC, ICIEF) 

Experience in pipetting (industry and school), titrations, purification, vacuum filtration, Molecular biology, Organic chemistry, Physical chemistry and other basic lab techniques 

Interpret, document, and communicate testing results 

Able to support multiple tasks, while adhering to expedited timelines and requests 

Presented metrics at monthly group meetings and lead weekly study forecast meetings 

Able to work independently or as part of a group 

Excellent written and verbal communication skills