Director, Formulation Development (R&D)

About the Role

The Director, Formulation Development (R&D) is a hands-on scientific expert responsible for developing and commercializing sterile injectable and nonsterile formulations across Empower Pharmacy's 503A and 503B portfolio. This role advances products from concept through formulation, stability, packaging, scale-up, technical transfer, and launch across various therapeutic areas, including men's health, women's health, HRT, weight management, GLP-1, peptides, longevity, sexual health, dermatology, and wellness. Success requires deep compounding expertise, technical problem-solving, execution rigor, and learning agility.

Responsibilities

• Formulation And Product Development:
  • Personally develops sterile injectable and nonsterile formulations, selecting APIs, excipients, concentrations, dosage forms, preparation methods, and packaging.
  • Resolves challenges involving solubility, compatibility, pH, osmolality, sterility, endotoxins, particulate matter, container closure integrity, and aseptic processing.
  • Improves existing formulations, stability, packaging, beyond-use dates, production efficiency, and material utilization while troubleshooting challenges.
• Stability And Analytical Development:
  • Designs and executes stability programs, establishes testing requirements, evaluates trends, and translates results into formulation decisions.
  • Evaluates assay, pH, osmolality, particulate matter, sterility, endotoxins, antimicrobial effectiveness, and container closure integrity.
  • Conducts formulation research, literature reviews, and excipient evaluations, using AI selectively to support research.
• Scale Up And Commercialization:
  • Converts laboratory formulations into scalable production processes, establishing compounding methods, process parameters, and packaging configurations.
  • Transfers formulations into 503A and 503B operations, partnering with cross-functional teams to resolve technical challenges.
  • Advances products through feasibility, formulation, testing, stability, packaging, production implementation, and launch.
• Quality And Regulatory Execution:
  • Develops formulations consistent with 503A/503B requirements, USP standards, cGMP principles, and Empower quality systems.
  • Creates accurate, traceable, and inspection-ready documentation.
  • Identifies and resolves formulation, sterility, stability, packaging, analytical, and manufacturing risks.
• Portfolio And Cross Functional Execution:
  • Translates provider demand and market opportunities into development opportunities across therapeutic areas.
  • Partners with cross-functional teams to move formulations from concept into routine operations.
  • Serves as a hands-on formulation expert, solving complex development problems and driving projects through completion.

Qualifications

• PharmD and active pharmacist license strongly preferred.
• 8+ years of pharmacy, formulation development, or compounding experience with substantial 503A and/or 503B experience.
• Significant hands-on sterile injectable and nonsterile development experience, including stability, aseptic processing, scale-up, and technical transfer.
• Proven ability to independently solve complex formulation challenges and execute a high-volume development portfolio.

Skills

• Deep expertise in 503A/503B formulation development, sterile injectables, nonsterile compounding, stability, and scale-up.
• Strong knowledge of USP standards, aseptic compounding, cGMP principles, and pharmaceutical development practices.
• Advanced ability to design stability studies, interpret analytical results, and translate findings into production processes.
• Key competencies include customer focus, strategic AI adoption, process optimization, collaboration, resourcefulness, complexity management, accountability, adaptability, and effective communication.

Benefits

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more.