Director, Sterile Formulation Development 503A

Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country serving the functional medicine markets.  

What sets us apart is our relentless focus on four core values: People, Quality, Service and Innovation. Our dedicated team of professionals collaboratively works to break new ground in the fields of manufacturing, distribution and quality control, providing a uniquely integrated approach to healthcare. Leveraging our vertical integration of the pharmaceutical supply chain, state-of-the-art technology, and a commitment to excellence, we are constantly pushing the boundaries of what is possible in medication accessibility and affordability.  

You're not just starting a job; you're joining a mission. We believe in empowering our team to innovate, grow, and drive real change in the healthcare industry. If you're a forward-thinker who thrives in a fast-paced, transformative environment, Empower is the place for you. Here, you’ll be encouraged to share your ideas, expand your skill set, and contribute to projects that genuinely make a difference. We prioritize the well-being of our team members, and we offer a supportive and engaging workplace where your contributions are not just recognized but celebrated.

Let’s revolutionize healthcare, together. Join us and be a part of something extraordinary.  

At the forefront of Empower Pharmacy’s sterile pharmaceutical innovation, the Director of Formulation Development – Sterile leads transformative projects that ensure safe, effective medication delivery in line with the highest regulatory standards. This role offers the chance to advance aseptic formulation science while expanding access to affordable, high-quality medications. The ideal candidate embraces artificial intelligence (AI) to enhance decision-making, optimize processes, and drive predictive development—fueling faster, smarter innovations that benefit patients nationwide.

• Leads sterile formulation strategy for small molecules, biologics, and combination products, collaborating with Regulatory Affairs and Quality to ensure validation, documentation, and regulatory readiness.
• Develops robust formulations that achieves targeted beyond-use dates and writes/reviews product development reports that meet regulatory standards.
• Oversees the development, scale-up, and technology transfer of aseptic injectable products, including lyophilized, reconstituted and ophthalmic formulations, ensuring alignment with United States Pharmacopeia (USP), Food and Drug Administration (FDA), and current Good Manufacturing Practices (cGMP).
• Integrates AI platforms and machine learning models to simulate formulation performance, predict stability trends, and reduce experimental cycles in formulation design.
• Drives sterile innovation by introducing cutting-edge technologies and formulation techniques to enhance solubility, stability, and delivery of sterile drug products while mentoring a high-performing team and managing third-party partnerships.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

• Strong leadership, critical thinking, and project management skills, with the ability to inspire a team and navigate complex technical and regulatory landscapes.
• Advanced technical knowledge of aseptic processing, parenteral formulation techniques, lyophilization, and FDA, USP, and cGMP compliance expectations; proven experience using AI tools to support formulation prediction, data mining, or simulation; proficient in Microsoft Office tools and formulation software.

Key Competencies

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

Values

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

• Minimum of 10 years of experience in pharmaceutical formulation development with at least 5 years focused on sterile/aseptic manufacturing in a leadership role.
• Requires a master’s degree in pharmaceutical sciences, chemistry, or a related field; a Doctor of Philosophy or Doctor of Pharmacy is strongly preferred.
• Certified Pharmaceutical Industry Professional preferred; Parenteral Drug Association (PDA) membership or American Association of Pharmaceutical Scientists (AAPS) membership strongly preferred
• Demonstrated experience leveraging AI in daily work to drive efficiency, solve problems, and enhance decision-making—adept at integrating AI-powered solutions into all workflows.

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: https://careers.empowerpharmacy.com/benefits/