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Senior Pharmaceutical Manufacturing Specialist

Empower Pharmacy
East Windsor, NJ Full Time
POSTED ON 4/26/2025
AVAILABLE BEFORE 5/25/2025
Location: East Windsor, New Jersey 08520, United States

Posted: April 25, 2025

Job Type: Full Time

Req# 4017

Manufacturing

Company Overview

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.

Position Summary

The Senior Pharmaceutical Manufacturing Specialist serves as a critical leader in advancing the performance, reliability, and quality of Empower’s aseptic manufacturing operations. This role combines technical mastery with strategic leadership to elevate operational standards, ensure compliance with evolving regulations, and implement scalable solutions that support our long-term growth. Through collaboration, innovation, and deep process ownership, this individual contributes directly to our mission of producing innovative medications that help people live healthier, happier lives, and to our vision of expanding access to quality, affordable medication.

Duties And Responsibilities

  • Leads cross-functional manufacturing initiatives that drive operational excellence, enhance yield and throughput, and ensure compliance with current Good Manufacturing Practices (cGMP) and United States Pharmacopeia (USP) guidelines.
  • Serves as a subject matter expert for complex manufacturing processes, equipment implementation, and aseptic techniques, including oversight of process validations, change control, and deviation investigations.
  • Analyzes production metrics and trends to identify process inefficiencies, develop data-driven solutions, and lead cross-departmental continuous improvement initiatives.
  • Develops and mentors technical staff, instilling a culture of excellence, accountability, and compliance with USP and cGMP standards.
  • Collaborates with Quality Assurance, Engineering, and Validation teams to ensure flawless execution of technology transfers, scale-up activities, and new product introductions.

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

  • Exceptional leadership, strategic thinking, and communication skills with a strong ability to collaborate across departments, influence change, and manage competing priorities in a fast-paced setting.
  • Advanced technical proficiency in aseptic techniques, validation protocols, environmental monitoring, and compliance with USP 797/800, cGMP practices.

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

  • Minimum of 7 years of experience in aseptic pharmaceutical manufacturing or compounding, with demonstrated leadership and advanced technical expertise in regulated production environments.
  • High school diploma with relevant experience required; Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related Life Science field highly preferred.
  • Certified Lean Six Sigma Green Belt (CLSSGB), Certified Lean Six Sigma Black Belt (CLSSBB), Certified Automation Professional (CAP), and Chief Compliance Officer (CCO) preferred.

Employee Benefits, Health, and Wellness

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/

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