Manager, Aseptic Manufacturing 503B - East Windsor, NJ - Empower Pharmacy

Position Summary:

The Manager, Aseptic Manufacturing, plays a critical role in shaping the future of Empower’s Aseptic Filling department. This position is at the forefront of ensuring that our manufacturing processes align with the highest standards of quality, safety, and efficiency. By leading a team of supervisors, senior operators, and floor operators, the Manager will drive the strategic direction of the department, fostering a culture of excellence and continuous improvement that aligns with Empower’s values of people, service, quality, and innovation.

 

In this role, the Manager will oversee the development, implementation, and monitoring of aseptic filling processes, ensuring that every product meets rigorous quality standards and regulatory requirements. This includes collaborating with Quality Assurance to uphold compliance with Good Manufacturing Practices (GMP), Food and Drug Administration (FDA) guidelines, and other industry regulations. By analyzing production data and implementing lean manufacturing principles, the Manager will identify areas for improvement, optimize performance, and minimize downtime.

 

The Manager will also be responsible for resource management, ensuring that labor, materials, and equipment are allocated effectively to meet production goals. Additionally, the role involves maintaining a proactive approach to safety, conducting regular audits, and leading training programs that keep the team updated on the latest technologies and best practices. Clear communication with senior management and cross-functional teams is essential to report on production performance, quality metrics, and areas for improvement.

 

We invite candidates who are passionate about leading and innovating within a dynamic manufacturing environment to apply. This role is integral to Empower’s mission of producing innovative medications that help people live healthier, happier lives. If you are driven by the opportunity to make a significant impact and are committed to advancing our vision of expanding access to quality, affordable medication, we encourage you to join our team.

Duties and Responsibilities:

• Oversees and leads the strategic direction for the Aseptic Filling department, ensuring safe, efficient, and compliant operations with right first time delivery on schedule and to specification.
• Manages and mentors a team of supervisors, senior operators, and floor operators to continuously achieve outstanding results through fostering a culture of excellence, teamwork, and continuous improvement.
• Develops, implements, and monitors aseptic filling processes to ensure product quality and consistency.
• Identifies and addresses systemic production issues, implementing corrective actions to minimize downtime and optimize performance.
• Collaborates with the Quality Assurance team to ensure all operations meet or exceed required quality standards.
• Participates in regular audits, inspections, and reviews to maintain compliance with GMP, Food and Drug Administration (FDA), and other regulatory requirements.
• Analyzes production data to identify trends, areas for improvement, and opportunities for increased efficiency.
• Implements lean manufacturing principles and continuous improvement methodologies to optimize production processes.
• Ensures all staff are professionally trained in aseptic techniques, equipment operation, and safety protocols.
• Develops and delivers ongoing training programs to keep the team updated on modern technologies, best practices, and regulatory changes.
• Manages the allocation of resources, including labor, materials, and equipment, to meet production schedules and business goals.
• Ensures all equipment is maintained in proper working order and coordinate repairs or upgrades as needed.
• Conducts regular safety audits and risk assessments to identify potential hazards and implements corrective actions.
• Maintains clear and effective communication with senior management, cross-functional teams, and external stakeholders.
• Prepares and presents regular reports on production performance, quality metrics, and significant issues or improvements.
• Leads initiatives aimed at enhancing the aseptic filling process, including the introduction of modern technologies and process optimizations.
• Encourages a culture of innovation and continuous learning within the team.
• Ensures operations comply with local, state, and federal regulations, including environmental impact, worker safety, and product quality.
• Stays informed about changes in regulations and industry standards, adjusting processes accordingly.
• Performs other duties 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 regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

Knowledge and Skills:

• Strong knowledge of aseptic processing, sterile manufacturing techniques, and equipment used in aseptic filling operations.
• Proficiency in analyzing production data, identifying trends, and implementing corrective actions to optimize processes.
• Proficient in the use of manufacturing software and tools, such as ERP systems and quality management software.
• Demonstrated ability to lead and mentor a team, fostering a culture of excellence, innovation, and continuous improvement.
• Excellent communication skills, with the ability to effectively collaborate with cross-functional teams, senior management, and external stakeholders.
• Strong problem-solving skills and the ability to make critical decisions under pressure.
• Strong commitment to safety, quality, and regulatory compliance.
• Ability to stay informed about industry trends, technological advancements, and regulatory changes impacting aseptic manufacturing operations.
• Flexibility to adapt to changing priorities and business needs.

 

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 a related field required.
• Master’s degree or higher in a relevant discipline preferred.
• Minimum of 8 years of experience in pharmaceutical manufacturing.
• At least 5 years in a supervisory or managerial role within aseptic manufacturing or sterile operations.
• Proven experience in managing aseptic filling operations with a deep understanding of GMP, FDA regulations, and other relevant compliance standards.
• Experience with lean manufacturing principles, continuous improvement methodologies, and process optimization in a highly regulated environment.
• Experience with quality management systems and participation in regulatory audits and inspections.
• Certification in Lean Six Sigma or similar process improvement methodologies (preferred).
• Project Management Professional (PMP) certification or equivalent is a plus.

Benefits:

• 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.