Bioassay Associate Director

 Leadership & Strategic ManagementTeam Oversight: Directly manage non-leadership employees and group leaders; handle scheduling, training, and fostering teamwork/morale.Operational Excellence: Ensure laboratory operations meet the highest quality, efficiency, and safety standards (including Health, Safety & Environmental responsibilities).Strategic Planning: Identify departmental unmet needs, focus on team time management, and implement LEAN projects or new technologies.Client Relations: Act as the primary technical contact for sponsors to coordinate studies and ensure expectations are met.Technical ResponsibilitiesMethod Development: Lead the development, qualification, and validation of cell-based analytical test methods for drug products and drug substances.  Design studies to elucidate the cellular mode of action (MoA) of drugs and characterize drug-target interactions and signaling pathwaysAssay Execution: Perform tissue culture-based potency assays, ELISAs, and molecular biology techniques (qPCR, ddPCR, flow cytometry, DNA/RNA extraction/purification).Laboratory Support: Maintain multiple cell lines, prepare solutions/culture media, and utilize automation and advanced pipetting techniques.Technical Resource: Serve as the internal expert to resolve complex technical problems and oversee the onboarding of new instrumentation.Quality, Compliance & DocumentationRegulatory Oversight: Ensure strict adherence to GXP (GMP/GLP) compliance; interface with the FDA and other regulatory agencies as needed.  Track record of developing and validating GMP methods to support drug commercialization.Scientific Review: Serve as the final reviewer for scientific rigor, conclusions, and the quality of reports sent to customers.Technical Writing: Author SOPs, policies, and procedures; maintain accurate records and ensure the integrity of all laboratory work.Accountability: Take ownership of reporting errors, deviations, or Out of Specification (OOS) occurrences promptly.