Executive search firm Monroe Consulting Group is recruiting on behalf of a leading medical group in the Philippines.
Our client is looking for a Compounding Laboratory Consultant to support the setup and operation of compliant compounding laboratories. This role requires travel, with the head office in Metro Manila.
Job Responsibilities:
- Strategic Planning & Advisory: Assess compounding scope (non-sterile, sterile, hazardous, IV), recommend lab models, and conduct regulatory gap analyses.
- Regulatory & Licensing Support: Guide FDA License to Operate applications, prepare documentation, and support inspections.
- Facility Design & Build-Out: Advise on lab layout, workflows, cleanroom classification, and coordinate with architects/contractors.
- Equipment Selection & Qualification: Define specifications, support procurement, oversee installation, commissioning, and calibration.
- Quality Management System: Develop SOPs, master formulation records, CAPA, environmental monitoring, and audit readiness.
- Validation & Readiness: Lead process validations, mock runs, pre-inspection assessments, and gap closure.
- Staffing & Training: Define roles, train personnel, and ensure competency in compounding practices and safety.
- Go-Live & Post-Launch Support: Monitor early operations, recommend improvements, and advise on future scaling.
- Reporting & Stakeholder Management: Provide progress updates, technical reports, and liaise with management, vendors, and regulators.
Key job qualifications include:
- Licensed pharmacist with 8-10+ years in pharmaceutical compounding.
- Hands-on experience in compounding laboratories, including at least one lab or pharmacy build-out.
- Strong knowledge of USP <795>, <797>, <800>, FDA LTO requirements, and SOP development.
- Experience in regulatory compliance, quality systems, inspection readiness, staff training, and equipment commissioning.
- Proven ability to lead multi-disciplinary teams and implement compliant laboratory operations.
