Leadership & Strategic Management
- Team 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. Ability to sell potency service to clients.
Technical Responsibilities
- Method 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 pathways
- Assay 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 & Documentation
- Regulatory 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.