Biologics Manufacturing Specialist
3 weeks ago
This role is responsible for ensuring the quality and integrity of biologics manufacturing processes. The ideal candidate will have strong experience in upstream processes and/or cell/gene therapy.
Key Responsibilities:- Deviation and Investigation Writing: Draft and approve deviations and investigations with a focus on root cause analysis and corrective actions.
- Unit Operations Expertise: Develop and maintain expertise in cell culture, bioreactors, TFF, chromatography, and filtration systems.
- Single-Use Disposable Systems: Collaborate with cross-functional teams to implement and maintain single-use disposable systems.
- Root Cause Analysis (RCA): Apply analytical skills to identify and resolve complex issues using tools like 5 Whys, 6Ms, and fishbone diagrams.
- TrackWise System: Utilize TrackWise or similar systems to manage and track deviations, investigations, and corrective actions.
- Upstream and/or Cell/Gene Therapy Experience
- Proven Experience in Authoring Deviations/Investigations
- Strong Biologics Experience
- Familiarity with cGMP Manufacturing Environments
- Strong Writing Skills
- Life Science or Engineering Degree with at least 5 years of relevant experience
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Senior Specialist, QA OTF
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent Inc is seeking a highly skilled Quality Assurance Specialist to provide support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. The ideal candidate will have a strong background in Quality Assurance, Good Manufacturing Practices (GMPs), and biologics/biopharmaceuticals.Key...
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Manufacturing Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent is seeking a highly skilled Manufacturing Manager to lead our biologics production team. As a key member of our operations team, you will be responsible for managing multiple teams to execute procedures for downstream manufacturing and support area of manufacturing using SOPs and batch records.This is a full-time on-site position,...
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Senior Specialist, Batch Disposition
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Senior Specialist, Batch Disposition
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent Inc is seeking a highly skilled Senior Specialist, Batch Disposition to join our team. As a key member of our Quality Assurance department, you will be responsible for providing quality assurance support for GMP documentation of master/working cell banks, bulk drug substance, and finished drug product.Key Responsibilities* Review...
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Manufacturing Operations Manager
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Supervisor, Client QA
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Senior Quality Assurance Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryThe Senior Quality Assurance Manager will oversee the Client Support processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. This role will drive engagement and create a culture where employees are motivated to do their best. The successful candidate will...
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Manufacturing Sciences
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Harmans, Maryland, United States Catalent Inc Full timeThe Manufacturing Sciences & Technology (MS&T) Engineer III will support Manufacturing Operations in the successful transfer and startup of clinical drug substance and drug product cGMP manufacturing operations at Catalent Gene Therapy.The MS&T Engineer III is actively engaged in the technical transfer of client and Catalent Process Development information...
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Senior Quality Assurance Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryThe Senior Quality Assurance Manager will oversee the Client Support processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. This role will build effective teams that apply their diverse skills and perspectives to achieve common goals, drive engagement, and...
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Senior Quality Assurance Supervisor
2 weeks ago
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Medical Staff Supervisor
2 weeks ago
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Quality Assurance Specialist
4 weeks ago
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Senior Scientist QC Compliance Specialist
3 weeks ago
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Quality Systems Audit Manager
4 weeks ago
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Quality Systems Audit Manager
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob SummaryCatalent Inc is seeking a highly skilled Quality Systems Audit Manager to join our team. As a key member of our quality assurance department, you will be responsible for managing and overseeing the core quality systems, including investigation/deviation management, CAPA tracking, change control, risk management, and quality metric tracking.Key...
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Quality Systems Audit Manager
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Title: Quality Systems Audit ManagerCatalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Quality Systems Audit Manager to join our team.Job Summary:The Quality Systems Audit Manager will be responsible for the management and oversight of the core quality systems,...
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Quality Systems Audit Manager
4 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeJob Title: Manager, Quality Systems AuditCatalent 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. We are seeking a highly skilled and experienced Manager, Quality Systems Audit to join our team.Job Summary:The Manager, Quality Systems...
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Director, Quality Assurance Batch Release Leader
2 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeDirector, Quality Assurance Batch ReleaseAbout the RoleThe Director, Quality Assurance Batch Release provides strategic oversight and leadership to QA Batch Record Review and Release supporting clinical and commercial drug substance and drug product manufacturing. This role ensures project objectives are met to a high-quality standard and according to...
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Senior Validation Engineer
3 weeks ago
Harmans, Maryland, United States Catalent Inc Full timeAbout the RoleCatalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Senior Engineer, Computer System Validation to join our team in Harmans, MD.Job SummaryThe Senior Engineer, Computer System Validation will be responsible for participating in validation projects related to...
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Senior Quality Control Supervisor
3 weeks ago
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