Job Title: Operations Pharmacist (PIC) – 503B Pharmaceutical Compounding Department: Operations Reports To: V.P. of Operations
POSITION OVERVIEW The Operations Pharmacist is responsible for overseeing pharmacy operations within a 503B outsourcing facility, ensuring the safe, compliant, and efficient production of both sterile and non-sterile compounded medications. This role requires extensive knowledge of regulatory frameworks governing pharmaceutical compounding, including FDA current Good Manufacturing Practices (cGMP), USP standards, DEA regulations, and applicable state pharmacy laws. The Operations Pharmacist serves as a key operational leader, guiding pharmacy and cleanroom personnel while promoting a strong culture of quality, compliance, and continuous improvement. This position also plays a central role in regulatory readiness, cross-functional coordination, and personnel development.
PRIMARY RESPONSIBILITIES
Manage day-to-day compounding activities for sterile and non-sterile products within the facility.
Ensure adherence to all applicable regulatory requirements, including FDA 503B guidance, cGMP standards, USP chapters, DEA regulations, and state laws.
Drive operational efficiency through process improvements, performance tracking, and workflow enhancements.
Oversee all aspects of controlled substance management, including procurement, storage, inventory reconciliation, and documentation.
Review and authorize Master Batch Records, Batch Production Records, and final product release documentation.
Ensure proper labeling, packaging, and verification of finished drug products.
Supervise environmental monitoring programs, cleanroom operations, and aseptic process validation activities.
Manage stability programs and ensure appropriate expiration dating based on scientific justification.
Support product development initiatives, including formulation, analytical testing, and method validation.
Lead and participate in regulatory inspections and audits; oversee corrective and preventive action (CAPA) activities.
Establish and maintain training programs and competency assessments for compounding personnel.
Oversee recruitment, onboarding, and performance management of pharmacy staff.
Maintain facility licensure and ensure compliance with all state-specific regulatory requirements for product distribution.
Direct recall activities and ensure proper handling of expired or non-conforming products.
Provide technical expertise and guidance on complex compounding and production-related matters.
Maintain continuous inspection readiness for regulatory agencies.
ADDITIONAL RESPONSIBILITIES
Contribute to the development and implementation of new initiatives aimed at improving compliance, safety, and operational performance.
Serve as a resource to internal teams on pharmacy and compounding-related topics. Act as a subject matter expert in pharmaceutical compounding practices.
Partner with Quality Assurance to strengthen investigation processes, product disposition decisions, and complaint resolution.
Stay current with evolving regulatory requirements and scientific advancements relevant to compounding.
QUALIFICATIONS & SKILLS
Comprehensive understanding of regulatory requirements related to compounding, including cGMP, USP standards, and controlled substance regulations.
Strong leadership capabilities with a focus on quality and compliance.
Hands-on experience with aseptic processing and sterile product manufacturing. Proficiency in technical documentation, including SOP development, deviation investigations, and report writing.
Excellent communication and interpersonal skills across all organizational levels.
Demonstrated commitment to continuous improvement and operational excellence.
EDUCATION & EXPERIENCE
Doctor of Pharmacy (PharmD) or equivalent advanced scientific degree required.
Active pharmacist license in good standing.
Experience with analytical testing, formulation development, or stability studies preferred.
Familiarity with Microsoft Office applications and quality management systems.
WORK ENVIRONMENT
Work is performed across multiple settings, including cleanrooms, laboratories, and office spaces.
Regular exposure to aseptic processing environments and potentially hazardous materials. Requires prolonged standing and occasional lifting (up to 15 pounds).
Strict adherence to gowning procedures and environmental controls is required.
Pay: $120,000.00 - $175,000.00 per year
Benefits:
- Health insurance
- Paid time off
Work Location: In person
