Orion Specialty Laboratories is building a new FDA-registered 503B outsourcing facility in Henderson, Nevada. We are a well-funded startup focused on sterile compounded medications, with initial production centered on testosterone. We seek a Pharmacist in Charge (PIC) with strong 503B experience to lead site operations and secure licensure approval.
Role Summary
You will serve as the PIC for a new 503B facility. You will lead site readiness, support regulatory approval, and oversee early-stage manufacturing. You will work on-site and help build the team, systems, and processes from the ground up.
Key Responsibilities
- Serve as PIC for the Nevada facility and represent the site before the Nevada Board of Pharmacy
- Lead efforts to obtain and maintain state and FDA compliance
- Oversee sterile compounding operations including vial filling and batch execution
- Ensure adherence to SOPs, batch records, and quality standards
- Supervise production and perform quality checks
- Support commissioning, qualification, and validation activities
- Prepare for and participate in FDA inspections
- Help hire and develop pharmacy staff, technicians, and quality personnel
- Oversee early production focused on sterile injectable testosterone
Required Qualifications
- Active Pharmacist license in Nevada
- Prior experience as PIC in a 503B outsourcing facility
- Minimum 3 years of relevant PIC or 503B leadership experience
- Strong background in sterile compounding and manufacturing operations
- Experience working with FDA regulations and inspections
- Ability to work on-site at least 30 to 32 hours per week
Preferred Qualifications
- Multi-state pharmacist licensure
- Experience with sterile injectable manufacturing and aseptic filling
- Direct interaction with FDA during inspections
- Startup or early-stage facility experience
Compensation and Benefits
- Salary range: $160,000 to $180,000, with total earnings up to $195,000 per year
- Bonus based on performance
- W2 employee with benefits
- Relocation support based on distance
- Full reimbursement for licensing and related costs
Work Environment
- Monday through Friday schedule
- Early-stage startup with a small team
- Expected growth to 20+ employees within the first year
- New equipment and increasing automation planned in Q3 and Q4
Why Join Orion
- Lead a new 503B facility from launch
- Direct impact on operations, team, and growth
- Opportunity to build systems and processes from the ground up
- Work with experienced leadership in pharmaceutical operations
Send CV to terryddickerson@gmail.comn or contact Terry Dickerson at 214-755-2242
