Director, Manufacturing - 503B

Company: Empower Pharmacy
Location: Houston
Posted on: January 23, 2025

Job Description:

Director, Manufacturing 503B - East Windsor, NJLocation: East Windsor, New JerseyPosted: July 17, 2024Req# 2656ManufacturingCompany OverviewEmpower 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 SummaryAs the Director of Manufacturing, you will be at the heart of Empower's mission to produce innovative medications that help people live healthier, happier lives. This critical role oversees the entire operation of our 503B Outsourcing Facility and Contract Manufacturing Organization, ensuring that we maintain the highest standards of safety, quality, service, and innovation. Your leadership will drive the strategic planning and execution necessary for our facilities and staff to operate effectively and efficiently, positioning Empower as a leader in the industry.In this hands-on director role, you will provide visionary leadership for all aspects of sterile drug production, from formulation and aseptic filling to inspection and labeling. Your expertise will be pivotal in overseeing the manufacture of our products, ensuring that we consistently meet production, performance, and quality standards. You will spearhead the implementation of automation in our sterile drug production processes, increasing operational efficiency and advancing our continuous improvement programs. By reviewing production reports and monitoring key metrics, you will ensure that safety, quality, financial, and delivery goals are met, and operational systems are optimized for visibility and progress.Furthermore, the Director will develop and execute long-term strategies for facility expansion, equipment, materials, technology, and workforce resources to ensure sustained manufacturing capacity and efficiency. At Empower, we are committed to fostering a culture of continuous improvement and collaboration. As the Director of Manufacturing, you will lead by example, providing coaching and mentorship to your team while promoting a positive company culture.If you are a dynamic, proactive leader and ready to take on this challenging and rewarding role, we invite you to apply now. Join Empower and contribute to our vision of expanding access to quality, affordable medication. Together, we can drive innovation and make a significant impact on the health and wellness of our communities.Duties and Responsibilities

• Provides leadership and direction for all aspects of sterile drug production to include formulation, aseptic filling, inspection, and labeling operations.
• Oversees the manufacture of products, ensuring production, performance, and quality standards are consistently met.
• Implements automation into the sterile drug production process.
• Transfers products into the facility and between manufacturing lines to increase operational efficiency.
• Leads the site's continuous improvement program with regards to production. Reviews production reports to ensure safety, quality, financial, and delivery goals and standards are met.
• Develops, implements, and monitors day-to-day operational systems and processes to provide visibility into the goals, progress, and obstacles of key initiatives.
• Plans, monitors, and analyzes key metrics for day-to-day operations to ensure efficient and timely completion of tasks. Drafts and revises Standard Operating Procedures (SOPs) and work instructions for all operational duties.
• Provides leadership to production management.
• Organizes departmental management structure and teams for optimal, efficient operations.
• Delivers progress and production reports to executive team members as requested.
• Responsible for product inventory levels for the site, ensuring inventory meets company expectations, playing an active role in Sales and Operating Planning through scheduling.
• Walks the production areas daily to review and assure operations are in a state of control.
• Confirms facility is maintained in a constant state of inspection readiness by ensuring staff are compliant with current Good Manufacturing Practices (cGMP) and related elements such as facilities, documentation (SOP, validation protocols, etc.), training, reports, and records.
• Collaborates diligently with other department heads for operational enhancement.
• Assists with manufacturing software development projects when needed, such as an enterprise resource planning implementation, electronic Quality Management System, etc.
• Creates and implements processes to establish stronger controls.
• Creates and implements processes to monitor and minimize waste.
• Leads hiring needs for department and plays an active role in the hiring process.
• Provides monthly analysis on operations, presenting to team and the respective Site Leadership Team.
• Ensures safety throughout operations and identifies preventative action plans to mitigate accidents.
• Ensures manufacturing equipment is operational and in good working order.
• Provides management with routine updates regarding the productivity and efficiency of operations.
• Initiates recommendations on purchasing of new equipment and improvements.
• Defines and monitors key performance indicators to evaluate the effectiveness and performance of direct reports.
• Provides constructive feedback, as necessary. Creates a culture of continuous improvement and provides coaching and mentorship.
• Promotes a collaborative work environment and positive company culture.
• 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 often required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. Employee must be able to get gown qualified and able to perform all duties on the manufacturing floor. Employees will regularly be exposed to areas in which moving mechanical parts, fumes, and toxic chemicals are present. The noise level for this position will vary and the employee may be exposed to loud noise levels. Employees may occasionally be required to lift up to 25 lbs. Vision abilities required by this job include close vision.Knowledge and Skills
  • Demonstrated technical knowledge in title 21 Code of Federal Regulations Parts 210 & 211 compliance for a Food and Drug Administration regulated facility (503B).
  • Demonstrated technical knowledge in vial, syringe filling operations.
  • Demonstrated technical knowledge in aseptic and lyophilization operations.
  • Strong proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook), Jira and other productivity software.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 a relevant field required, scientific field preferred.
        • 20+ years of experience in cGMP manufacturing or equivalent work experience, 25+ years preferred.
        • 15+ years' experience in a manager level position or higher running aseptic manufacturing operations is required.Employee Benefits, Health, and Wellness
          • 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.
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Keywords: Empower Pharmacy, Sugar Land , Director, Manufacturing - 503B, Executive , Houston, Texas