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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 Continuous Improvement (CI) Senior Specialist - 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. This role 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
Bachelor's degree with an emphasis in Life Science, Engineering or Business field
Minimum of 4 years of GMP / Commercial 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
Experience leading team improvement efforts in production facilities
Lean Six Sigma – Yellow or Green Belt Certification preferred
Fully competent in the use of common computer software – Microsoft Windows, Microsoft Word, and Microsoft Excel, Microsoft PowerPoint
Ability to successfully prioritize, and manage large, complex projects, deadlines, and tasks with little supervision in both team and independent environment
Pay
The anticipated salary range for this position in Maryland is $93,000 to $120,000 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.
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
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.
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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Localização
Harmans, Maryland, United States of America, 21077
ID do trabalho0088259Categoria
Qualidade & Regulatórios
Data de publicação
03/10/2025
Are you experienced in driving operational transformation through lean and six sigma methodologies? Join a dynamic team focused on fostering a culture of continuous improvement to enhance manufacturing excellence, ensuring the delivery of life-saving therapies while prioritizing patient safety and quality.
Localização
Philadelphia, Pennsylvania, United States of America, 19154
ID do trabalho0084139Categoria
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Data de publicação
03/13/2025
We are looking for an experienced professional to provide Quality Assurance support, ensuring compliance with regulatory standards and driving continuous improvement in manufacturing and packaging operations. This role is pivotal in fostering a culture of quality, enhancing patient safety, and supporting the mission of delivering life-saving products.
Localização
Harmans, Maryland, United States of America, 21077
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We are looking for a detail-oriented professional to provide Quality Assurance support in GMP documentation, ensuring compliance with regulatory standards. This role is vital in advancing innovative therapies, contributing to a mission of improving patient health through excellence in quality and safety.
Localização
Harmans, Maryland, United States of America, 21077
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Are you experienced in Quality Assurance within the biopharmaceutical industry? Join a dynamic team dedicated to ensuring compliance with GMP standards, reviewing critical documentation, and driving quality improvements. Contribute to the mission of enhancing patient lives through innovative therapies in a fast-paced environment.
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Harmans, Maryland, United States of America, 21077
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Join a dynamic team dedicated to enhancing lives through quality assurance in supplier management. Drive supplier audits, oversee compliance, and lead improvement initiatives while ensuring adherence to GMP standards. Contribute to the mission of delivering life-saving therapies by fostering excellence and innovation in supplier quality processes.
Localização
Greenville, North Carolina, United States of America, 27834
ID do trabalho0083694Categoria
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Localização
Harmans, Maryland, United States of America, 21077
ID do trabalho0088462Categoria
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We are looking for a dedicated professional to provide quality assurance support for GMP manufacturing projects, ensuring compliance and oversight from inception to closure. This role is vital in delivering life-enhancing products, contributing to the mission of improving health and well-being through excellence in biopharmaceutical development.
Localização
Harmans, Maryland, United States of America, 21077
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Join a dynamic team dedicated to improving patient lives by providing quality assurance support for advanced therapeutic products. This role involves overseeing GMP operations, collaborating across functions, and ensuring compliance with regulatory standards, all while fostering a culture of excellence and safety.
Localização
Philadelphia, Pennsylvania, United States of America, 19154
ID do trabalho0087752Categoria
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Data de publicação
03/13/2025
Seeking a Quality Assurance expert to lead compliance initiatives, mentor teams, and drive continuous improvement in a dynamic environment. This role is vital in ensuring excellence in quality and safety, contributing to the mission of enhancing lives through innovative healthcare solutions.
