Continuous Improvement, Specialist

Catalent Pharma Solutions; Maryland; On-site; USD 63,000 - 80,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Tuition Reimbursement

Paid time off

Job summary

Catalent Pharma Solutions in Harmans, MD, is seeking a Continuous Improvement, Specialist to drive Lean Six Sigma initiatives at our FDA-approved gene therapy manufacturing campus. You will lead improvement projects, analyze KPIs, and mentor project leaders to deliver sustainable process enhancements.

The role requires a Life Science/Engineering/Business degree and 1–3 years in manufacturing, with GMP experience and Yellow/Green Belt preferred.

Qualifications

• Bachelor's degree in Life Science, Engineering, or Business.
• 1–3 years of manufacturing-related work with CI/Operational Excellence experience preferred.
• Experience in Biologics, Cell, or Gene Therapy operations preferred.
• GMP regulated environment experience preferred.
• Lean Six Sigma Yellow or Green Belt certification preferred.

Responsibilities

• Lead continuous improvement initiatives using Lean Six Sigma to enhance site KPIs.
• Drive advanced problem solving, analyze root causes, and implement sustainable improvements.
• Promote data-driven decision making through performance metrics and analytics.
• Coach Lean Six Sigma project leaders and remove barriers for successful projects.
• Champion a culture of continuous improvement and change across the organization.
• Support Lean Six Sigma training, project execution, and sharing of best practices.
• Develop and manage site performance reporting for People, Safety, Quality, Delivery and Cost.
• Collaborate with regional/global/site leadership to align priorities and progress.

Skills

Lean Six Sigma

Problem solving

Communication skills

Change management

Project management

Education

Bachelor's degree in Life Science/Engineering/Business

Job description

Continuous Improvement, Specialist Position Summary

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 Continuous Improvement, Specialist to join our team. In this role, you will identify and prioritize improvement opportunities using Lean Six Sigma tools to enhance key site KPIs. You will facilitate problem-solving, promote data-driven decision-making, and mentor project leaders to ensure successful outcomes. This position plays a key role in fostering a culture of continuous improvement and operational excellence across the organization.

The Role

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.

The Candidate

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.

Preferred Skills & Background

Six Sigma training.

Manufacturing background.

Pay

The anticipated salary range for this position in MD is $63,000 – $80,000 Plus Bonus. 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.

Why You Should Join Catalent

• 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.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world.

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.

Equal Opportunity Employer

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.