Job Description
Job description
Principal Specialist, Continuous Improvement
Summary:
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 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-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.
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 practices
The 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 required
• 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
Position Benefits:
• Defined career path and annual performance review and feedback process
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• 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. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
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 [email protected]. 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.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Principal Specialist, Continuous Improvement
Summary:
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 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-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.
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 practices
The 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 required
• 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
Position Benefits:
• Defined career path and annual performance review and feedback process
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• 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. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
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 [email protected]. 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.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
💡 Quick Summary
Seeking a career-building opportunity? The Principal Specialist| Continuous Improvement position is now open for candidates interested in the Manufacturing Jobs sector. This role in Severn offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Manufacturing Jobs is a plus.
