Director of Laboratory Services (PharmD Required)
Sweetgrass Pharmacy and Compounding, Mount Pleasant, SC, United States
Sweetgrass Pharmacy and Compounding is seeking a highly experienced
Director of Laboratory Services
to lead sterile and non‑sterile compounding operations. This leadership role is responsible for regulatory compliance, quality assurance, staff management, and operational excellence within a high‑performing laboratory environment.
The ideal candidate is a licensed
PharmD
with deep expertise in
USP 797 and USP 800 , strong leadership experience, and a proven track record in sterile compounding.
Key Responsibilities Leadership & Team Management
Lead, mentor, and manage Lab Technicians and laboratory staff
Conduct performance evaluations and oversee staff development
Facilitate daily huddles and coordinate lab workflow
Ensure adherence to SOPs and company standards
Regulatory Compliance & Quality
Ensure compliance with USP 797, USP 800, FDA, PCAB, NABP, and Board of Pharmacy regulations
Maintain inspection readiness and accreditation standards
Oversee environmental monitoring:
Surface sampling (weekly)
Air sampling (monthly)
Manage competency programs and compliance documentation
Develop corrective action plans for out‑of‑compliance findings
Laboratory Operations
Oversee sterile and non‑sterile compounding activities
Ensure equipment maintenance, certification, and calibration
Maintain cleanroom standards and documentation
Coordinate third‑party testing and filter integrity testing
Inventory & Supply Management
Manage ordering and inventory of drugs, chemicals, and lab supplies
Monitor expiration dates and maintain accurate inventory records
Maintain SDS and Certificates of Analysis
Oversee labeling processes and supply coordination
Compounding Oversight
Ensure all compounded products meet standards for sterility, potency, and quality
Support compounding of sterile (low, medium, high‑risk) and non‑sterile preparations
Oversee preparation of injections, ophthalmics, IVs, and other formulations
Hazardous Drug Program (USP 800)
Lead hazardous drug safety program and compliance
Ensure staff competency and adherence to safety protocols
Monitor environmental controls and minimize exposure risks
Minimum Qualifications
Doctor of Pharmacy (PharmD) – required
Active pharmacist license in good standing
5+ years of leadership experience in pharmacy, lab, or healthcare setting
5+ years of sterile compounding experience
Strong knowledge of USP 797 and USP 800
Preferred Qualifications
Experience in 503A or 503B compounding
Experience with regulatory inspections (FDA, PCAB, NABP)
Board certification (e.g., BCSCP or BCPS)
Skills & Competencies
Master of Business Administration (MBA) Degree
Strong leadership and team management skills
High attention to detail and documentation accuracy
Knowledge of sterile and non‑sterile compounding SOPs
Financial and operational awareness
Ability to work cross‑functionally with pharmacy, operations, and leadership teams
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Director of Laboratory Services
to lead sterile and non‑sterile compounding operations. This leadership role is responsible for regulatory compliance, quality assurance, staff management, and operational excellence within a high‑performing laboratory environment.
The ideal candidate is a licensed
PharmD
with deep expertise in
USP 797 and USP 800 , strong leadership experience, and a proven track record in sterile compounding.
Key Responsibilities Leadership & Team Management
Lead, mentor, and manage Lab Technicians and laboratory staff
Conduct performance evaluations and oversee staff development
Facilitate daily huddles and coordinate lab workflow
Ensure adherence to SOPs and company standards
Regulatory Compliance & Quality
Ensure compliance with USP 797, USP 800, FDA, PCAB, NABP, and Board of Pharmacy regulations
Maintain inspection readiness and accreditation standards
Oversee environmental monitoring:
Surface sampling (weekly)
Air sampling (monthly)
Manage competency programs and compliance documentation
Develop corrective action plans for out‑of‑compliance findings
Laboratory Operations
Oversee sterile and non‑sterile compounding activities
Ensure equipment maintenance, certification, and calibration
Maintain cleanroom standards and documentation
Coordinate third‑party testing and filter integrity testing
Inventory & Supply Management
Manage ordering and inventory of drugs, chemicals, and lab supplies
Monitor expiration dates and maintain accurate inventory records
Maintain SDS and Certificates of Analysis
Oversee labeling processes and supply coordination
Compounding Oversight
Ensure all compounded products meet standards for sterility, potency, and quality
Support compounding of sterile (low, medium, high‑risk) and non‑sterile preparations
Oversee preparation of injections, ophthalmics, IVs, and other formulations
Hazardous Drug Program (USP 800)
Lead hazardous drug safety program and compliance
Ensure staff competency and adherence to safety protocols
Monitor environmental controls and minimize exposure risks
Minimum Qualifications
Doctor of Pharmacy (PharmD) – required
Active pharmacist license in good standing
5+ years of leadership experience in pharmacy, lab, or healthcare setting
5+ years of sterile compounding experience
Strong knowledge of USP 797 and USP 800
Preferred Qualifications
Experience in 503A or 503B compounding
Experience with regulatory inspections (FDA, PCAB, NABP)
Board certification (e.g., BCSCP or BCPS)
Skills & Competencies
Master of Business Administration (MBA) Degree
Strong leadership and team management skills
High attention to detail and documentation accuracy
Knowledge of sterile and non‑sterile compounding SOPs
Financial and operational awareness
Ability to work cross‑functionally with pharmacy, operations, and leadership teams
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