Senior Research Pharmacist in Charge
The Lundquist Institute
Summary
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.
Job description
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.
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; contribute to budgets and cost-recovery models; support timely study start-up and site activation.
- Conduct SIVs; write study-specific procedures; maintain study files; ensure protocol compliance and patient safety.
- Provide accurate, timely investigational drug information to clinical teams; support Cerner or equivalent EHR verification processes.
- Maintain a safe, clean, and orderly work environment; ensure unidirectional workflow and appropriate gowning, PPE, and biosafety practices.
Requirements
- Doctor of Pharmacy (PharmD) or equivalent from an accredited school of pharmacy
- PGY1 residency required
- Current, active pharmacist license in the State of California (CA DCA)
- BLS certification required per institutional CPR/Code Blue policy
- Minimum 10-15 years of experience in hospital/clinical pharmacy with direct IDS responsibilities and sterile/HD compounding
- Experience launching or leading IDS programs, including building SOPs, QMS/CAPA, and KPI dashboards
- Demonstrated experience with complex trials (oncology, vaccine, intrathecal) and advanced therapies (gene/cell therapy; viral vectors such as AAV/lentivirus; oligonucleotides; N-of-1/personalized therapeutics)
- Experience with eHR verification, drug accountability systems, and audit/inspection readiness
- Excellent written and verbal communication
- Mastery of USP 797/800 aseptic technique, HD handling, beyond-use dating, and environmental monitoring
- Proficiency in ICH-GCP, FDA/21 CFR, IRB/IBC workflows, and biosafety for ATMPs
- Strong IP accountability, blinding/randomization, and documentation practices; audit-proof recordkeeping
- QMS development and execution (deviations, root cause analysis, CAPA, change control, risk assessment/FMEA)
- Cleanroom lifecycle management (design review, IQ/OQ/PQ, media fills, smoke studies)
- Inventory management across ambient/refrigerated/frozen/cryogenic; temperature excursion investigations
- Program-building, project management, and resource planning; budget and cost-recovery acumen
- Ability to lead through inspections and cross-functional initiatives; high reliability mindset
- Competence with IRT/IWRS, eTMF/eISF interfaces, eHR, barcoding, and data/reporting tools
- Familiarity with environmental monitoring systems and validated temperature monitoring platforms
- Ability to lift up to 25 lbs and handle cryogenic/frozen shipments per safety procedures
Benefits
- FT Benefit
Company overview
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (TLI) is a leading nonprofit biomedical research organization founded in 1952 by visionary physicians seeking better treatments for their patients. Operating with a unique "bedside to bench to bedside" approach, TLI translates clinical challenges into scientific inquiry and discoveries back into patient care. The institute employs over 150 principal investigators and more than 550 research staff who conduct over 600 active studies annually, including approximately 130 clinical trials. Affiliated with the David Geffen School of Medicine at UCLA and partnered with Harbor-UCLA Medical Center, TLI focuses on cutting-edge translational research across multiple domains including cancer biology, respiratory medicine, infectious diseases, translational genomics, and metabolic disorders. The organization also operates extensive community health programs serving over 60,000 underserved women and children monthly in Los Angeles County, promoting health equity while fostering the next generation of scientific leaders through robust education and training programs.