As a Senior Formulation Research and Development Scientist at Empower, you will help shape the future of our innovative medications by optimizing sterile injectable formulations for both small molecule and biologic drugs. Your expertise will ensure the development of safe, effective, and stable products that meet global regulatory standards, advancing our mission to deliver high-quality, affordable medications that improve lives. Join us in making a meaningful impact on patients' health through collaboration and innovation.

• Develops and optimize sterile injectable formulations, including solutions, suspensions, and lyophilized products, for small molecule and biologic drugs, utilizing thermal characterization and lyophilization cycle development to ensure optimum stability, efficacy, and compliance with regulatory standards.
• Conducts pre-formulation studies, excipient selection, and stability testing to assess physical, chemical, and microbiological stability, ensuring formulation safety and meeting requirements of global regulatory guidelines such as United States Pharmacopeia (USP) and International Council for Harmonisation.
• Leads scale-up processes from lab to pilot and commercial-scale production in collaboration with manufacturing science and technology teams, adhering to good manufacturing practices and regulatory frameworks to ensure high-quality, compliant products.
• Oversees aseptic processing, sterilization techniques (e.g., heat sterilization, filtration), and fill-finish operations, providing technical support and ensuring alignment with current regulatory expectations for sterile manufacturing.
• Collaborates with cross-functional teams, mentor junior scientists, and manage third-party vendors to streamline formulation development, troubleshoots technical issues, and enhance formulation processes while maintaining compliance with Food and Drug Administration and European Medicines Agency regulatory requirements.

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.

• Excellent analytical, problem-solving, and communication skills, with the ability to work collaboratively across multidisciplinary teams and effectively translate complex scientific data into practical solutions that meet regulatory and patient needs.
• Expertise in formulation techniques, good manufacturing practices, regulatory requirements, and proficiency in laboratory equipment and software tools such as Microsoft Excel, Word, laboratory management systems, and advanced understanding of regulatory compliance including the 21 Code of Federal Regulations Part 210 & 211, United States Pharmacopeia USP <795>, USP <797>, and USP <800>.

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 5 years of experience in formulation development for sterile injectable products, with hands-on experience in lyophilized formulations, parenteral formulations, microspheres, biologic products, and formulation stability studies, excipient compatibility studies, and regulatory submissions.
• Bachelor's degree in pharmaceutical sciences, chemistry, or a related field required; Masters or Doctor of Philosophy degree in pharmaceutical sciences or a related discipline for advanced expertise in formulation development strongly preferred.
• Certified Pharmaceutical Industry Professional or related certification is preferred.

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/