Lead Pharmacist in Sterile Compounding

1 week ago

Los Angeles, California, United States Xseer Pharmaceuticals Full time
Job Overview

Lead Pharmacist, Sterile Compounding


Position Overview:
The Lead Pharmacist in Sterile Compounding is tasked with managing the production processes for compounded sterile formulations, ensuring strict compliance with current Good Manufacturing Practices (cGMP), USP 797/800, and departmental Standard Operating Procedures (SOP). This role involves supervising and coordinating the daily functions of Sterile Compounding Supervisors, Operators, and Prep Operators across various shifts. The Lead Pharmacist collaborates with management and support teams to achieve safety, quality, and delivery objectives.


Key Responsibilities:
• Oversee assigned manufacturing operations, which may include processing source materials, equipment preparation, sterilization, aseptic filtration, filling, inspection, and packaging.
• Manage the injectable value stream from inception to release.
• Review and revise manufacturing documentation related to production areas.
• Responsible for maintaining the production schedule.
• Coordinate and deliver cGMP, job task, and safety training for manufacturing personnel.
• Generate, update, and maintain area SOPs.
• Ensure compliance with regulatory standards (USP and/or cGMP).
• Actively engage in resolving manufacturing equipment and process challenges.
• Conduct deviation investigations for assigned responsibilities and implement corrective actions to prevent recurrence.
• Initiate continuous process enhancements.
• Monitor and coordinate inventory with the Supply Chain team.
• Prepare production monitoring reports and participate in product cost analysis and budgeting.
• Analyze and recommend capital expenditures and efficiency improvements in manufacturing areas.
• Collaborate with all supporting departments (e.g., QA/QC, Facilities & Engineering, Supply Chain, Production Control) to promptly address production issues with appropriate quality considerations.
• Assist in validating processes and equipment.
• Ensure that all environmental monitoring limits are adhered to in all areas.
• Revise, create, and ensure compliance with SOPs regarding process changes or regulatory guidelines as necessary.
• Maintain work schedules for hourly employees, monitor attendance, and assess performance.
• Lead and assist in the recruitment and interviewing of new personnel, providing coaching and counseling as needed.
• Allocate time effectively to fulfill assigned duties that support business objectives.
• Interact constructively with employees, managers, and cross-functional peers.
• Effectively resolve issues related to sterile manufacturing.
• Perform additional duties as assigned.


Knowledge and Skills:
• Comprehensive understanding of standard concepts, practices, and procedures within the aseptic pharmaceutical sector.
• In-depth knowledge of mechanical systems.
• Proficiency in Microsoft Office 365.


Core Competencies:
• Customer Focus: Ability to cultivate strong customer relationships and deliver customer-centric solutions.
• Optimizes Work Processes: Knowledge of the most effective and efficient processes to achieve objectives, with a focus on continuous improvement.
• Collaborates: Fosters partnerships and works collaboratively with others to meet shared goals.
• Resourcefulness: Effectively secures and deploys resources.
• Manages Complexity: Capable of making sense of complex, high-quality, and sometimes contradictory information to solve problems effectively.
• Ensures Accountability: Holds self and others accountable for meeting commitments.
• Situational Adaptability: Adjusts approach and demeanor in real-time to align with the shifting demands of various situations.
• Communicates Effectively: Develops and delivers multi-mode communications that clearly convey the unique needs of different audiences.


Experience and Qualifications:
• Master of Science in Life Sciences or a valid Pharmacist qualification.
• Prior leadership experience in an aseptic production environment is essential.
• Registered with the California Board of Pharmacy as a Pharmacist.
• Previous cGMP experience in sterile product manufacturing is preferred.
• Minimum of 3 years of management or supervisory experience.
• Strong background in cGMP, aseptic processing, and USP 797/800.
• Must successfully complete gowning tests and procedures and media fill tests to qualify as a cleanroom operator.
• Ability to gown into a cleanroom on a daily basis.
• Must be capable of working in an aseptic environment.

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