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Principal Specialist, Continuous Improvement - Severn Maryland
Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/06/2025
Principal Specialist, Continuous ImprovementSummary:Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.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--. 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 Principal Specialist, Continuous Improvement - 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.-- The Principal Specialist, Continuous Improvement 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-5pmCatalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role: - 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
- Assist in the identification and sharing of best practices across the organization
- Manage weekly / monthly site reporting (People, Safety, Quality, Delivery, Cost):
- Develop data collection systems and performance reporting
- Prepare and deliver complex presentations to ensure adequate understanding, resources, and support for ongoing and future CI projects
- Coordinate with Global and Regional Deployment Leaders regarding project status, issues, and accomplishments
- Network and collaborate with other Catalent CI Leaders Managers/Directors to share best practicesThe Candidate:
- Bachelor's degree with an emphasis in Life Science, Engineering or Business field and a minimum of 7 years of GMP/ Commercial manufacturing related work with demonstrated experience in Continuous Improvement and/or Operational Excellence preferred.
- Master's degree with an emphasis in Life Science, Engineering, or Business field and a minimum of 5 years
- 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 - Black belt preferred
- Excellent verbal and written communication skills with the ability to work with people at all levels of the organization, including the executive leadership team
- Ability to successfully prioritize, and manage large, complex projects, deadlines, and tasks with little supervision in both team and independent environmentThe anticipated salary range for this position in Maryland is $118,720 to $163,240 and annual bonus, when eligible.-- The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Position Benefits:
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