Formulation Scientist – Sterile

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 three core values: People, Quality and Service. 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 heart of Empower's commitment to innovation and quality, the Formulation Scientist, Sterile role is pivotal in advancing our mission to produce top-tier health and wellness medications. This position embodies our core values: people, quality, service, and innovation, by leading the development and optimization of sterile formulations, including lyophilized products. By ensuring product stability and quality that meet industry standards, you will directly contribute to our promise of delivering exceptional medications that improve patient outcomes.

In this dynamic role, you will spearhead the development and scale-up of complex dosage forms, encompassing pre-formulation, formulation, and process development. Your expertise will be crucial in conducting thorough analyses and troubleshooting sterile processes, identifying areas for improvement, and implementing innovative solutions. By developing and executing thermal characterization and cycle development protocols, you will ensure our products consistently meet the highest standards of excellence.

Collaboration is key at Empower, and as a Formulation Scientist, you will work closely with leaders across manufacturing, quality, and engineering to align development activities with our company systems and commercial-scale manufacturing requirements. You will also coordinate with Sales to understand client and industry requirements, ensuring that our products meet market needs. Your role as a subject matter expert will involve tracking all phases of research and development projects and managing master formulas.

If you are excited to contribute to our mission and be part of a team dedicated to making a difference in health and wellness, we encourage you to apply for the Formulation Scientist, Sterile position at Empower Pharmacy. Your contributions will support our mission to expand access to quality, affordable medications. Embrace the opportunity to be at the forefront of pharmaceutical innovation and make a meaningful impact every day.

• Leads development and optimization of sterile formulations including lyophilized, ensuring product stability and quality meet industry standards.
• Develop and scale up formulations and manufacturing processes for complex dosage forms with minimal guidance, including pre-formulation, formulation, and process development.
• Conducts thorough analysis and troubleshooting of Sterile processes to identify areas for improvement and implement innovative solutions. Develops and executes thermal characterization of a drug product.
• Develops and executes cycle development protocols from new products through production lyophilizers.
• Develops manufacturing processes for Research and Development formulations ensuring the technical transfer is successful for large-scale batches.
• Proactively apply scientific or engineering expertise to develop solutions to complex technical, operational, and/or business problems which require ingenuity and creativity.
• Writes and reviews master formulas, manufacturing procedures, standard operating procedures, stability protocols, reports, and product development reports.
• Executes all research and development studies through in-house and external laboratories.
• Coordinates closely with Sales to understand clients’ and/or industry requirements for specific products or product lines.
• Coordinates Research and Development production scheduling with Manufacturing.
• Works closely with leadership from different departments such as manufacturing, quality, and engineering to ensure development activities align with established company systems and long-term commercial-scale manufacturing requirements.
• Serve as the subject matter expert for all sterile formulations, and product development opportunities at Empower Pharmacy.
• Tracks all phases of Research and Development projects using project management tools.
• Assists recipe management system, Master Formulation Record, to ensure all recipes are detailed, updated, and executable.
• Coordinates and assists with new product training as needed.
• Resolves production formulation issues and provides on-the-floor oversight as needed.
• Performs other duties as assigned.

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 occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.

• Strong understanding of Sterile principles, lyophilization processes, formulation techniques, and analytical methods.
• Knowledgeable on small molecule and large molecule formulation.
• Knowledge of additional industry, regulatory, and compliance guidelines such as Parenteral Drug Association, International Conference of Harmonization, etc., preferred.
• Knowledge of laboratory methods, aseptic/cleanroom practices, and technical documentation preferred.
• Excellent strategic view as well as hands-on problem-solving and analytical skills
• Detail-oriented and possess a high level of accuracy.
• Must be a self-starter and results driven.
• Ability to enter the production environment as needed (sterile lab and cleanroom).
• Ability to maintain confidentiality and act with discretion when handling sensitive information.
• Proven ability to adapt to a fast-paced environment.

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 other accountable to meet commitment.
• 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.

• Advanced degree in a scientific field such as Chemistry, Chemical Engineering, Pharmaceutics, Pharmacy, or a related field required.
• 5 years of related sterile formulation experience required.
• Proven experience in sterile product development, process optimization, and process improvement within the pharmaceutical or biotechnology industry.
• Experience developing drug products from concept through commercialization.
• Experience with 21 Code of Federal Regulation Part 210 & 211, United States Pharmacopeia (USP) <795>, USP <797>, and USP <800> compliance required.
• Experience with Microsoft Office required.

• No-Cost Medication: Get your prescribed compounded medications at no cost, ensuring your health without the financial burden.
• Onsite Health & Wellness – IV Therapy Drips: Rejuvenate with complimentary onsite IV Therapy drips, enhancing your well-being and energy levels.
• Comprehensive Medical, Dental, and Vision Options: Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
• Telehealth visits: Access board-certified Doctors anytime, anywhere for you and your family.
• Paid & Volunteer Time Off: Enjoy paid time off for personal pursuits and contribute to causes you care about with volunteer time off.
• Paid Holidays (8 scheduled; 2 floating): Celebrate with eight scheduled holidays and two floating holidays, giving you flexibility and time for personal traditions.
• Life & AD&D Coverage: Secure your and your family's financial future with life and accidental death and dismemberment (AD&D) insurance.
• FSA (Flexible Spending Account): Manage healthcare expenses smartly with pre-tax dollars in a Flexible Spending Account (FSA).
• 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.
• Company Paid Long-Term Disability: Provided at no cost, which replaces 60% of your income if you become disabled for a long period of time.
• Flexible Schedules: Balance work and life seamlessly with our flexible scheduling options.
• Rewards & Recognition Program: Your hard work doesn't go unnoticed – enjoy rewards and recognition beyond your paycheck.

Additional Voluntary Benefits

• Accident Insurance: Pays a lump sum benefit to help cover expenses following an accidental injury.
• Hospital Indemnity Insurance: Enhance your peace of mind with supplemental hospital insurance for unexpected stays.
• Critical Illness: Protect your finances from the expenses of a serious health issue.
• Short-Term Disability: Protect your income during illness or injury with short-term disability coverage.
• Supplemental Life & AD&D: Add an extra layer of financial protection for you and your loved ones with supplemental life and AD&D coverage.
• Legal Services: Access professional legal assistance to address concerns confidently.
• Identity Theft Protection: Safeguard your identity and finances with our identity theft protection benefit.
• Pet Insurance: Care for your furry family members with our pet insurance coverage.
• Employee Assistance Program: Confidential counseling and support services for a holistic approach to your well-being.