World Reach Pharma, LLC
World Reach Pharma (WRP), a newly reactivated FDA-registered 503B outsourcing facility specializing in sterile and non-sterile compounded drug products, is seeking a highly experienced Vice President, Pharmacy Development. This executive will play a critical leadership role in operationalizing the facility for commercial readiness and will assume responsibility as the Pharmacist-in-Charge (PIC). The ideal candidate will bring a blend of regulatory, clinical, and operational expertise to lead WRP through pre-operational validation, licensure, and commercial scale-up.
Key Responsibilities Pharmacist-in-Charge (PIC) Accountability
Serve as the designated PIC per NYS Board of Pharmacy requirements.
Ensure all compounded products meet FDA, DEA, and state regulations.
Supervise compliance of cleanroom operations, environmental monitoring, aseptic processing, and batch recordkeeping.
Oversee final release of drug products, including CoA issuance and deviation logs.
Regulatory, Licensing & Inspection Readiness
Lead efforts to obtain and maintain 503B outsourcing facility status and required licenses.
Act as primary liaison during inspections by FDA, DEA, and NY State Board of Pharmacy.
Prepare, review, and maintain all validation protocols and batch release documentation.
Facility and Equipment Commissioning
Ensure facility layout and operations align with cGMP workflow.
Oversee equipment calibration and cleanroom certification.
Address issues like surveillance setup, facility cleanup, and labeling systems.
Commercial Launch Preparation
Develop and implement SOPs for all production stages.
Collaborate with QA and technician teams to validate workflow.
Drive initial production readiness for nasal spray.
Strategic Leadership & Operational Buildout
Report directly to the General Manager/President.
Hire and mentor pharmacy and QA staff.
Align operations with corporate objectives and expansion planning.
Qualifications
Licensed Pharmacist (New York State) with eligibility to serve as PIC.
8–10 years of experience in sterile compounding and 503B FDA-regulated environments.
Track record managing cGMP-compliant facilities and regulatory audits.
Knowledge of USP
/ , DEA protocols, and FDA 503B compliance.
Experience in start-up or turnaround pharmaceutical operations preferred.
Strong leadership, communication, and team-building skills.
Performance Measures
Obtain NY State Pharmacy and DEA Controlled Substance licenses within first 90 days.
Pass FDA pre-operational inspections with zero major findings.
Produce and release first commercial batch by launch target date.
Implement SOPs, batch records, and CAPA systems within 6 months.
Onboard full facility team aligned to validated workflow.
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Key Responsibilities Pharmacist-in-Charge (PIC) Accountability
Serve as the designated PIC per NYS Board of Pharmacy requirements.
Ensure all compounded products meet FDA, DEA, and state regulations.
Supervise compliance of cleanroom operations, environmental monitoring, aseptic processing, and batch recordkeeping.
Oversee final release of drug products, including CoA issuance and deviation logs.
Regulatory, Licensing & Inspection Readiness
Lead efforts to obtain and maintain 503B outsourcing facility status and required licenses.
Act as primary liaison during inspections by FDA, DEA, and NY State Board of Pharmacy.
Prepare, review, and maintain all validation protocols and batch release documentation.
Facility and Equipment Commissioning
Ensure facility layout and operations align with cGMP workflow.
Oversee equipment calibration and cleanroom certification.
Address issues like surveillance setup, facility cleanup, and labeling systems.
Commercial Launch Preparation
Develop and implement SOPs for all production stages.
Collaborate with QA and technician teams to validate workflow.
Drive initial production readiness for nasal spray.
Strategic Leadership & Operational Buildout
Report directly to the General Manager/President.
Hire and mentor pharmacy and QA staff.
Align operations with corporate objectives and expansion planning.
Qualifications
Licensed Pharmacist (New York State) with eligibility to serve as PIC.
8–10 years of experience in sterile compounding and 503B FDA-regulated environments.
Track record managing cGMP-compliant facilities and regulatory audits.
Knowledge of USP
/ , DEA protocols, and FDA 503B compliance.
Experience in start-up or turnaround pharmaceutical operations preferred.
Strong leadership, communication, and team-building skills.
Performance Measures
Obtain NY State Pharmacy and DEA Controlled Substance licenses within first 90 days.
Pass FDA pre-operational inspections with zero major findings.
Produce and release first commercial batch by launch target date.
Implement SOPs, batch records, and CAPA systems within 6 months.
Onboard full facility team aligned to validated workflow.
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