Continuous Improvement, Specialist

• Shift: Mon-Fri 8am-5pm
• Location: Harmans, MD
• 100% Onsite

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.

We have an opportunity for a

• Lead continuous improvement initiatives using Lean Six Sigma methodologies to enhance key site KPIs.
• Drive advanced problem-solving efforts, analyze root causes, and implement sustainable process improvements.
• Promote data-driven decision-making through performance metrics, reporting, and analytics.
• Coach and mentor Lean Six Sigma project leaders, helping remove barriers and ensure successful project completion.
• Champion a culture of continuous improvement and change management across the organization.
• Support Lean Six Sigma training, project execution, and the sharing of best practices across teams and sites.
• Develop and manage site performance reporting for People, Safety, Quality, Delivery, and Cost metrics.
• Collaborate with regional, global, and site leadership to communicate project progress, align priorities, and drive operational excellence.
• Perform other duties as assigned.

• Bachelor's degree with an emphasis in Life Science, Engineering, or Business field.
• 1 - 3 years of 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 preferred.
• Experience leading team improvement efforts in production facilities.
• Lean Six Sigma - Yellow or Green Belt Certification 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 environments.

• Six Sigma training.
• Manufacturing background.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement.