Position Summary: The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory activities for teams focused on supporting both commercially approved CDx sample analysis as well as CDx programs in development. They will use their scientific expertise to lead design, development and validation efforts for cell therapy assays to support multiple fast-paced clinical and non-clinical studies for clients engaged in cutting-edge research.

Requirements

, specifically relevant to companion diagnostics, along with the ability to put these

into practice developing robust assays that easily pass FDA scrutiny. Experience with developing and managing programs following FDA.

, and assay execution of both cell-based and non-cell-based assays is required. ,NY, CA, RI, PA) use their expertise to guide assay development and troubleshooting. The position requires direct experience in all aspects of companion diagnostics, large molecule regulated bioanalysis and working knowledge of industry best practices.

The person will work closely with QA and Regulatory to ensure regulatory compliance and work with project managers to ensure laboratory delivery and timely and efficient client communication. Lastly, the ideal candidate will have had experience with hosting and/ or participating in regulatory audits. Essential functions of the job include but are not limited to: Mentor and lead all companion diagnostic teams to ensure high quality compliant data.

Works with Lab Director to identify and provide continuing education to laboratory testing personnel that is relevant to laboratory practices Direct staff to ensure consistent scientific standards and compliance with Precision procedures and regulatory expectations on all projects Monitors and provides metrics, KPIs to senior leadership which includes but is not limited to: quality metrics, TAT, assay failure rate, volumes and revenue. Monitors inventory (client and precision inventory) and lab supplies; ensures staff perform regular inventory counts and updates the inventory software system. Ensure lab is run efficiently, reviews processes, SOPs and implements improvements regarding operational excellence.

Is main contact for clients regarding scientific updates and manage client expectations for all projects within the team. Provides verbal or written updates as necessary.

for assay validation.

Oversee the execution of all work to ensure the team understands and is meeting study compliance for all work performed, including study budget

. Responsible for trouble shooting and correcting all scientific issues/problems within the team Prepare/review/writes critical documents including protocols, reports, and SOPs Work collaboratively with other technical teams in resource sharing and providing technical expertise Maintain and s