Must-Haves
- PharmD or equivalent pharmacy degree.
- Active pharmacist license in good standing and ability to obtain licensure in GA.
- Seven or more years of advanced compounding experience, including meaningful personal ownership of formulation development. Exceptional candidates with fewer years may be considered if their work demonstrates unusual depth.
- Demonstrated experience with all four environments:
- Sterile compounding.
- Nonsterile compounding.
- Hazardous preparations.
- Nonhazardous preparations.
- Has personally authored, substantially redesigned, or scientifically defended master formulation records—not merely approved formulas developed by vendors or other employees.
- Strong understanding of pharmaceutical chemistry, dosage-form design, compatibility, stability, BUD assignment, packaging, storage, and analytical testing.
- Direct experience in a 503A pharmacy or exceptionally strong adjacent experience combined with a sophisticated understanding of 503A practice.
- Ability to evaluate scientific literature critically and distinguish strong evidence from weak or nontransferable information.
- Experience working across pharmacy operations, quality, clinicians, technicians, laboratories, and vendors.
- Willingness to work primarily on-site and relocate.
Preferred
- Board Certified Sterile Compounding Pharmacist, or BCSCP.
Key responsibilities
Formulation development
- Design and optimize patient-specific sterile and nonsterile compounded preparations.
- Evaluate APIs, excipients, vehicles, concentrations, dosage forms, routes of administration, and delivery devices.
- Assess solubility, chemical and physical compatibility, degradation pathways, preservative strategy, adsorption, leaching, oxidation, hydrolysis, light sensitivity, temperature sensitivity, and more.
- Evaluate whether filtration, terminal sterilization, aseptic processing, or another preparation method is technically appropriate.
- Select appropriate containers, closures, administration devices, storage conditions, and shipping configurations.
- Perform or verify pharmaceutical calculations and evaluate practical manufacturability and reproducibility.
- Develop alternatives when a requested formulation is not sufficiently supported or cannot be prepared safely and reliably.
Scientific and regulatory assessment
- Conduct and document comprehensive literature searches.
- Evaluate the quality and applicability of published stability, compatibility, and clinical information.
- Determine whether ingredients are appropriate and eligible for use in 503A compounding.
- Review certificates of analysis, supplier qualifications, component specifications, and storage requirements.
- Understand the distinction between default USP BUDs and BUDs supported by appropriate stability-indicating and microbiological evidence.
- Identify when sterility, endotoxin, potency, stability, preservative-effectiveness, particulate, pH, container-closure-integrity, or shipping studies are appropriate.
- Maintain strong working knowledge of USP <795>, <797>, and <800>, applicable FDA requirements, state-board requirements, and pharmacy policies.
FDA currently states that bulk substances used in 503A compounding must meet specified eligibility conditions and be accompanied by a valid certificate of analysis from an appropriately registered manufacturing establishment. USP <795>, <797>, and <800> respectively address nonsterile preparations, sterile preparations, and hazardous-drug handling.
Clinical and interdisciplinary collaboration
- Work with prescribers to understand the therapeutic objective and patient-specific need.
- Collaborate with the metabolic dietitian on clinically and pharmaceutically appropriate preparations for patients with complex nutritional and metabolic requirements.
- Evaluate age, disease state, route, administration method, allergies, intolerances, excipient restrictions, laboratory information, and other patient-specific considerations.
- Clearly communicate technical limitations, risks, evidence gaps, and alternatives.
- Be willing to decline or redirect a requested formulation when the available evidence, ingredients, process, or testing cannot support safe and reproducible preparation.
Operational implementation
- Transfer newly developed or revised formulations into pharmacy operations.
- Train pharmacists and technicians on critical formulation and process requirements.
- Observe initial preparations and confirm that written procedures are practical and reproducible.
- Establish appropriate packaging and cold-chain requirements.
- Evaluate shipping-container performance and available vendor qualification data.
- Monitor complaints, preparation failures, adverse events, stability concerns, and operational feedback for signals that require reassessment.
