What are the responsibilities and job description for the Associate Director, Continuous Improvement position at Catalent Pharma Solutions?
Position Summary
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 Associate Director, Continuous Improvement will work collaboratively with the Sr Director of CI and the entire CI team to ensure attainment of CI excellence across the BWI/Harmans site. This includes building expertise, establishing predictable and consistent processes, focusing on business priorities, and accelerating new technologies. This role will support the development of site leadership team on lean principles. The role will also play a pivotal role in mentoring the site leadership team to embed the skills and behaviors that will result in a sustainable continuous improvement culture within the BWI/Harmans site and ensuring that there is proper focus on standardization, simplification, and rapid adoption of best practices. Reporting to the CI Sr Director, this person is a dedicated resource responsible for operational transformation using lean, six sigma, and other advanced problem-solving and process improvement tools.
This is a full-time on-site position, Monday – Friday 8:00am – 5:00pm.
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.
The Role
Identify continuous improvement opportunities throughout the BWI/Harmans site 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.
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.
Other duties as assigned.
The Candidate
Bachelor's degree with an emphasis in Life Science, Engineering or Business field.
7+ years of phase 3 and commercial stage manufacturing related work with demonstrated experience in Continuous Improvement and/or Operational Excellence.
Three (3) years of experience in Biologics, Cell, or Gene Therapy operations and production.
Four (4) years of experience leading team improvement efforts in production facilities.
Experience in a GMP regulated environment.
Certification in Lean Six Sigma Black Belt from a reputable organization.
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 environment.
Salary : $153,000 - $205,000
