Director of Sterile Manufacturing Operations

4 weeks ago

East Windsor Mercer County NJ, United States Empower Pharmacy Full time
Job Summary

Empower Pharmacy is seeking a highly experienced Director of Manufacturing to oversee the entire operation of our 503B Outsourcing Facility and Contract Manufacturing Organization. As a key member of our leadership team, you will be responsible for ensuring that we maintain the highest standards of safety, quality, service, and innovation in our manufacturing processes.

Key Responsibilities
  • Provide leadership and direction for all aspects of sterile drug production, including formulation, aseptic filling, inspection, and labeling operations.
  • Oversee the manufacture of products, ensuring production, performance, and quality standards are consistently met.
  • Implement automation into the sterile drug production process to increase operational efficiency.
  • Develop and execute long-term strategies for facility expansion, equipment, materials, technology, and workforce resources to ensure sustained manufacturing capacity and efficiency.
  • Lead the site's continuous improvement program with regards to production, reviewing production reports to ensure safety, quality, financial, and delivery goals and standards are met.
  • Develop, implement, and monitor day-to-day operational systems and processes to provide visibility into the goals, progress, and obstacles of key initiatives.
  • Plan, monitor, and analyze key metrics for day-to-day operations to ensure efficient and timely completion of tasks.
  • Provide leadership to production management, organizing departmental management structure and teams for optimal, efficient operations.
  • Deliver 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.
  • Walk the production areas daily to review and assure operations are in a state of control.
  • Confirm 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.
  • Collaborate diligently with other department heads for operational enhancement.
  • Assist with manufacturing software development projects when needed, such as an enterprise resource planning implementation, electronic Quality Management System, etc.
  • Create and implement processes to establish stronger controls.
  • Create and implement processes to monitor and minimize waste.
  • Lead hiring needs for department and play an active role in the hiring process.
  • Provide monthly analysis on operations, presenting to team and the respective Site Leadership Team.
  • Ensure safety throughout operations and identifies preventative action plans to mitigate accidents.
  • Ensure manufacturing equipment is operational and in good working order.
  • Provide management with routine updates regarding the productivity and efficiency of operations.
  • Initiate recommendations on purchasing of new equipment and improvements.
  • Define and monitor key performance indicators to evaluate the effectiveness and performance of direct reports. Provide constructive feedback, as necessary. Create a culture of continuous improvement and provide coaching and mentorship.
  • Promote a collaborative work environment and positive company culture.
  • Perform other duties as assigned.

Requirements
  • 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.

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.

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