Senior Research Pharmacist in Charge

Overview/Purpose Of Position The Senior Research Pharmacist is the senior clinical and operational leader for the CDCRC’s Investigational Drug Service (IDS) and USP-compliant sterile and hazardous drug compounding unit. The pharmacist establishes, operates, and continuously improves a high-performing IDS within a new 1,079 sq ft pharmacy suite designed to USP 797/800, California Board of Pharmacy, and California Building Code standards. The role ensures safe, compliant, and efficient support for Phase I-IV clinical trials, including advanced therapy medicinal products (ATMPs), gene and cell therapies, and complex sterile compounding, while leading quality systems, inspection readiness, and multidisciplinary collaboration. Essential Functions Investigational Product (IP) Management and Trial Support Provide end-to-end IP oversight (feasibility through close-out/archival) for sponsor- and investigator-initiated studies, device-drug combinations, pediatric/adult oncology, vaccines, intrathecal, chemotherapy, and gene/cell therapies. Author and maintain protocol-specific pharmacy manuals; manage randomization/blinding, unblinding, temperature excursion plans, and IP chain-of-custody across ambient, refrigerated, frozen, and cryogenic conditions. Coordinate with IRT/IWRS; maintain audit-ready accountability and records. Program Leadership and Development Stand up and lead IDS operations: service catalog, staffing model, training plan, SOP framework, quality management system (QMS), KPIs/dashboards, audit schedules, and cost-recovery models. Lead cleanroom commissioning/qualification (IQ/OQ/PQ), media fills, smoke studies, and environmental monitoring. Compounding and Dispensing (Sterile/HD/Non-sterile) Perform sterile compounding per USP 797 ISO Class 7 standards; hazardous drug handling per USP 800; non-sterile per USP 795. Verify identity and integrity of ATMPs (e.g., viral vectors, cellular therapies); prepare per protocol and IRB-approved orders. Quality Systems, Compliance, and Safety Maintain SOPs, work instructions, forms, logs; implement QMS including incident reporting, CAPA, deviation/exception management, and continuous improvement. Ensure compliance with FDA/ICH-GCP, Joint Commission, state/federal laws, privacy and data integrity standards; maintain inspection readiness. Collaboration and Stakeholder Engagement Serve as SME and liaison with investigators, clinicians, coordinators, nurses, IRB, IBC, EHS, Office of Research Administration and Clinical Trials and Industry Agreements.. Participate in sponsor/monitor visits, audits, and regulatory inspections; present findings and corrective actions. Education, Training, and Leadership Mentor pharmacists/technicians; oversee onboarding, competency assessments (e.g., aseptic technique, HD handling), and ongoing GCP/GLP/GMP training. Represent IDS in governance committees and external collaborations. Non-Essential Functions Special projects, research/quality improvement initiatives, formulary/shortage mitigation, presentations, publications, and professional committee participation. Shared on-call coverage per rotating schedule. Basic Duties And Responsibilities Coordinate all aspects of IDS operations: drug receipt, quarantine, verification, segregation, secure storage, dispensing, return/destruction per sponsor requirements, and documentation. Maintain systems for inventory control, expiry checks, environmental/temperature monitoring, and excursion response. Develop and enforce policies/SOPs for storage, preparation, distribution, and control of IP, including narcotic/controlled substance oversight and reconciliation. Conduct feasibility and coverage analyses #J-18808-Ljbffr The Lundquist Institute