Principal Formulation Development Pharmacist / Formulation Specialist
Location: Atlanta, GA (Relocation Assistance Available)
Job Type: Full-Time | Direct Hire
Industry: Specialty Pharmacy | 503A Compounding Pharmacy
About the Opportunity
Insight Global is seeking a highly specialized Principal Formulation Development Pharmacist / Formulation Specialist for a nationally recognized 503A compounding pharmacy. This is not a traditional dispensing, staff pharmacist, or production management role. We are looking for a scientific leader who can develop, defend, and optimize complex compounded formulations while establishing the organization's long-term formulation development strategy.
This individual will serve as the subject matter expert for formulation science, driving innovation across sterile and nonsterile, hazardous and nonhazardous compounded preparations. The ideal candidate possesses extensive experience developing patient-specific formulations from first principles and can translate advanced pharmaceutical science into reproducible pharmacy operations.
This is a high-priority strategic hire supporting the development of specialized therapies for patients with inherited metabolic disorders, mitochondrial diseases, and other rare conditions.
ResponsibilitiesFormulation Development & Optimization
- Conduct comprehensive audits of existing compound formulations, master formulation records, preparation processes, ingredient selections, packaging, storage conditions, testing protocols, and assigned beyond-use dates (BUDs).
- Design and optimize scientifically sound sterile and nonsterile compounded preparations tailored to individual patient needs.
- Evaluate active pharmaceutical ingredients (APIs), excipients, vehicles, concentrations, dosage forms, routes of administration, and delivery systems.
- Assess formulation feasibility through evaluation of solubility, compatibility, degradation pathways, oxidation potential, hydrolysis risk, preservative systems, adsorption, leachables, and other critical formulation considerations.
- Determine appropriate preparation methodologies including aseptic processing, terminal sterilization, filtration strategies, and alternative manufacturing approaches.
- Develop alternative therapeutic and formulation solutions when requested preparations cannot be safely or reliably compounded.
Scientific Evaluation & Regulatory Compliance
- Conduct and document extensive literature reviews related to stability, compatibility, safety, efficacy, and formulation development.
- Critically evaluate scientific publications, stability studies, and clinical evidence to support formulation decisions.
- Establish evidence-based beyond-use dating strategies utilizing USP guidance, stability-indicating data, microbiological considerations, packaging systems, and storage conditions.
- Review certificates of analysis, supplier qualifications, raw material specifications, and ingredient sourcing practices.
- Ensure compliance with USP <795>, USP <797>, USP <800>, applicable FDA guidance, state board regulations, and internal quality standards.
- Identify appropriate testing requirements, including potency, sterility, endotoxin, stability, preservative effectiveness, particulate matter, pH, and container-closure integrity evaluations.
Program Development & Scientific Leadership
- Establish and maintain a formal formulation development process, including feasibility assessment, risk evaluation, component selection, testing protocols, implementation approval, and performance monitoring.
- Build and support specialized pharmaceutical services focused on patients with metabolic disorders, mitochondrial disease, and other rare conditions.
- Serve as the organization's primary scientific resource for complex formulation challenges and patient-specific compounding needs.
- Provide technical guidance and recommendations to leadership, quality, operations, and clinical teams.
Clinical Collaboration
- Partner with prescribers, pharmacists, dietitians, laboratory personnel, and pharmacy staff to develop individualized therapeutic solutions.
- Evaluate patient-specific factors including age, disease state, route of administration, excipient restrictions, allergies, intolerances, laboratory data, and treatment goals.
- Communicate evidence gaps, formulation limitations, risks, and alternative options to stakeholders.
- Exercise scientific judgment regarding formulation requests that cannot be sufficiently supported by available evidence or safe preparation practices.
Operational Implementation
- Translate formulation science into practical, reproducible pharmacy processes.
- Develop and maintain master formulation records, specifications, process controls, in-process checks, release criteria, storage requirements, and shipping instructions.
- Train pharmacists and pharmacy technicians on newly developed and revised formulations.
- Evaluate packaging systems, cold-chain requirements, shipping configurations, and vendor qualification data.
- Monitor operational feedback, stability concerns, preparation failures, adverse events, and complaints to identify opportunities for continuous improvement.
Required QualificationsPreferred Candidate Profile – Pharmacist
- PharmD or equivalent pharmacy degree.
- Active pharmacist license in good standing with ability to obtain Georgia licensure.
- 7+ years of advanced compounding experience with significant hands-on formulation development responsibilities.
- Demonstrated experience across:
- Sterile Compounding
- Nonsterile Compounding
- Hazardous Drug Preparations
- Nonhazardous Preparations
- Experience personally authoring, redesigning, validating, or scientifically defending master formulation records.
- Strong knowledge of pharmaceutical chemistry, dosage form design, compatibility assessment, stability evaluation, analytical testing, packaging systems, and BUD assignment.
- Direct experience within a 503A compounding pharmacy or comparable formulation-development environment.
- Proven ability to critically analyze scientific literature and apply evidence-based decision making.
- Experience collaborating with pharmacy operations, quality teams, clinicians, laboratories, suppliers, and vendors.
- Willingness to work primarily onsite and relocate if needed.
Preferred Qualifications
- Board Certified Sterile Compounding Pharmacist (BCSCP).
- Experience supporting rare disease, metabolic disorder, or mitochondrial disease patient populations.
- Experience developing and validating complex sterile formulations.
Alternative Candidate Profile – Pharmaceutical Scientist
Exceptional candidates with an MS or PhD in Pharmaceutics, Pharmaceutical Sciences, Medicinal Chemistry, Analytical Chemistry, or a related scientific discipline may also be considered if they possess:
- Significant experience developing patient-specific or compounded pharmaceutical formulations.
- Deep knowledge of 503A compounding practices and USP standards.
- Experience creating pharmacy documentation and supporting operational implementation.
- Experience working under licensed pharmacist oversight within regulated compounding environments.
What Makes This Role Unique
- Opportunity to build and shape formulation-development strategy for a growing specialty compounding pharmacy.
- High-impact role focused on complex and rare disease patient populations.
- Significant scientific autonomy and influence across pharmacy operations.
- National search with relocation assistance available for qualified candidates.
- Opportunity to work at the intersection of pharmaceutical science, innovation, and personalized medicine.
Pay: $120,000.00 - $180,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Work Location: In person
