Catalent Pharma Solutions - Harmans, MD

posted 13 days ago

Full-time - Senior
Harmans, MD
Chemical Manufacturing

About the position

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. The Continuous Improvement (CI) Senior Specialist - BWI / Harmans Site is responsible for leading CI initiatives across the BWI campus. This includes building expertise, establishing predictable and consistent processes, focusing on business priorities, and accelerating new technologies. This role will be part of a site CI team charged with developing and imbedding the skills and behaviors that will result in a sustainable continuous improvement culture within the BWI site with focus on standardization, simplification, and rapid adoption of best practices. This position reports to the Site CI Director. By focusing on CI, this role will contribute to Catalent's Patient First philosophy by driving the site to improve processes and continue to meet the growing needs of clients and patients with the highest quality drugs in a timely manner. This is a full-time on-site position, M-F 8am-5pm. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

Responsibilities

  • Identify continuous improvement opportunities throughout the organization by routinely studying, prioritizing, and selecting projects that leverage lean six sigma tools to drive improvements in key site KPIs.
  • Facilitate advanced problem solving and analysis of specific improvement opportunities leading to the implementation of effective sustainable solutions.
  • Promote the use of data and metrics for identifying improvement opportunities and problem-solving activities.
  • Coach and mentor lean six sigma Project Leaders to complete projects by identifying and eliminating barriers.
  • Engage teams as a Change Agent to help establish a Continuous Improvement culture and execute advanced problem-solving activities.
  • Support design, development, and delivery of lean six sigma training and project execution.
  • Manage weekly / monthly site reporting (People, Safety, Quality, Delivery, Cost).
  • Other duties as assigned.

Requirements

  • Bachelor's degree with an emphasis in Life Science, Engineering or Business field.
  • Minimum of 4 years of GMP / Commercial manufacturing related work with demonstrated experience in Continuous Improvement and/or Operational Excellence preferred.
  • Experience in Biologics, Cell, or Gene Therapy operations and production preferred.
  • Experience in a GMP regulated environment.
  • Experience leading team improvement efforts in production facilities.
  • Lean Six Sigma - Yellow or Green Belt Certification preferred.
  • Fully competent in the use of common computer software - Microsoft Windows, Microsoft Word, and Microsoft Excel, Microsoft PowerPoint.
  • Ability to successfully prioritize, and manage large, complex projects, deadlines, and tasks with little supervision in both team and independent environment.

Benefits

  • Competitive medical benefits and 401K.
  • 152 hours of PTO + 8 Paid Holidays.
  • Dynamic, fast-paced work environment.
  • Opportunity to work on Continuous Improvement Processes.
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