Manager, Sterile Manufacturing 503B

Position Summary

The Manager, Sterile Manufacturing 503B is responsible for architecting, scaling, and sustaining Empower’s global sterile manufacturing platform—the core engine behind the most advanced 503B compounding operation in the nation. This leader transforms systems, people, and processes into a synchronized powerhouse of safety, precision, and speed. Leveraging artificial intelligence, data intelligence, and operational rigor, this role ensures growth never outpaces quality or compliance. The Manager oversees the integration of AI-driven manufacturing systems that predict, prevent, and perfect performance. Success in this role is measured by flawless execution, regulatory excellence, and intelligent scalability—delivering benchmark results that expand Empower’s ability to improve and save lives at scale.

Duties and Responsibilities

Operational Excellence

• Design and implement scalable aseptic workflows across multi-line, multi-site environments using AI-driven process optimization.
• Establish rigorous operating rhythms with live data visibility and real-time performance tracking.
• Eliminate process variability through statistical process control and predictive monitoring systems.
  
  

Quality and Compliance

Institutionalize cGMP, USP /, and 21 CFR Part 210/211 compliance into all manufacturing routines.

Lead proactive audit-readiness programs with AI-supported inspection analytics.

Drive lifecycle validation using science-based, data-backed quality risk management tools.

AI-Driven Manufacturing Intelligence

• Deploy machine learning to predict process drift, equipment failure, and contamination risks.
• Implement digital twins and sensor-fusion systems for real-time operational insight.
• Automate quality feedback loops using AI algorithms for anomaly detection and corrective action.
  
  

Team Development and Leadership

• Recruit and develop high-performing sterile manufacturing professionals aligned with Empower’s mission.
• Design a scalable organization model with defined accountability and advancement pathways.
• Build a culture of ownership, urgency, and operational pride across the team.
  
  

Strategic Growth and Integration

• Partner with Engineering, Quality, and Supply Chain to align capacity with demand forecasts.
• Lead cross-functional initiatives that integrate automation and digital manufacturing systems.
• Translate growth objectives into executable roadmaps, balancing innovation with compliance.
  
  

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.

Knowledge and Skills

• Proven expertise in sterile pharmaceutical manufacturing operations, aseptic processing, and cGMP environments.
• Proficiency in applying AI and machine learning for predictive analytics, digital twins, and process optimization.
• Strong background in quality systems, validation, and regulatory compliance across FDA and USP standards.
• Ability to design scalable systems, lead multidisciplinary teams, and deliver complex projects under rapid growth.
  
  

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.
  
  

Experience And Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field required; advanced degree preferred.
• 7 years of experience in sterile pharmaceutical or biomanufacturing environments, with 3 years in leadership roles.
• Demonstrated success implementing AI, automation, and digital manufacturing systems.
• Proven ability to build teams, scale operations, and lead in high-growth, regulated industries.
  
  

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