Senior Specialist, Batch Disposition

2 weeks ago


Harmans, Maryland, United States Catalent Inc Full time
Job Summary

Catalent 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 documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP)
* Interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of cell and gene therapy products
* Independently execute batch record review for completeness, accuracy, and cGMP compliance
* Support the evaluation and lot disposition of intermediates, finish bulk drug substance, and drug product

Requirements

* Masters' degree in a Scientific or Life Science discipline with 2-4 years' experience in biologic, biopharmaceutical, or regulated industry
* OR Bachelors' degree in a Scientific or Life Science discipline with 4-6 years' experience in biologic, biopharmaceutical, or regulated industry
* Proficient knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs
* Proficient with biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish

What We Offer

* Competitive salary with yearly bonus potential
* 152 hours of paid time off annually + 8 paid holidays
* Medical, dental, and vision benefits effective day one of employment
* Tuition reimbursement
* Generous 401K match and paid time off accrual

About Catalent Inc

Catalent is a global drug development and delivery leader, producing more than 70 billion doses per year. We are committed to preserving and bettering lives through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

  • Harmans, Maryland, United States Catalent Inc Full time

    Job SummaryWe are seeking a highly skilled Senior Specialist, Batch Disposition to join our team at Catalent Inc. This role is responsible for providing Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance, and finished drug product.Key ResponsibilitiesReview documentation for manufacturing activities associated...


  • Harmans, Maryland, United States Catalent Inc Full time

    Director, 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...


  • Harmans, Maryland, United States Catalent Inc Full time

    Catalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a highly skilled Senior Quality Assurance Manager to join our team.The successful candidate will be responsible for providing support and oversight to the Quality Control Team as they support the Quality Control and Batch Disposition...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job SummaryThe Senior Quality Control Manager, QC Program Management is responsible for overseeing the Quality Control and Batch Disposition departments, ensuring timely testing of samples and delivery of QC results. This role requires strong leadership and communication skills to support the QC Client Services Team.Key ResponsibilitiesProvide strategic...


  • Harmans, Maryland, United States LanceSoft, Inc. Full time

    Job Title – QA Batch Record ReviewerLocation – LanceSoft, Inc.Duration: 3 months contract possibly extensionPay Range: $30.00 - $35.00 USD hourly on W2ResponsibilitiesPerform Product Disposition and Lot Closure, ensuring commercial and clinical products meet regulatory standards.Review batch-related documentation to resolve issues and release products,...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job SummaryCatalent Inc is seeking a highly skilled Director, Medical Safety Quality and Compliance to provide strategic oversight and leadership to QA Batch Record Review and Release supporting clinical and commercial drug substance and drug product manufacturing.The ideal candidate will have a strong background in quality assurance, with experience in...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job 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...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job Summary:The Senior Quality Assurance Supervisor 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.Key Responsibilities:Supervise Client Support processes and personnel.Ensure staff are fully trained on all cGMP manufacturing...


  • Harmans, Maryland, United States Catalent Inc Full time

    About the RoleThe Manager, QC Program Management is responsible for providing strategic support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables are met as part of client's analytical implementation.Key ResponsibilitiesManage the OTL for...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job SummaryThe Manager, QC Client Services is responsible for providing support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables as part of client's analytical implementation.Key ResponsibilitiesManage the OTL for analytical method...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job Summary:The Senior Quality Control Supervisor will lead the day-to-day operations in the assigned area of the Quality Control (QC) department at Catalent Inc. This role is responsible for ensuring the quality of products and adhering to regulatory requirements.Key Responsibilities:Supervise the QC team and ensure they are fully trained on all cGMP...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job SummaryThe Manager, QC Program Management is responsible for providing support and oversight to the QC Client Services Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables as part of client's analytical implementation.Key ResponsibilitiesBe the face of Catalent Quality Control...

  • Supervisor, Client QA

    2 weeks ago


    Harmans, Maryland, United States Catalent Inc Full time

    The Senior Quality Assurance Specialist, Client Projects, is responsible for providing QA support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. Overseeing the Client Support team and serves as the dedicated Client QA Representative and...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job SummaryThe Senior Quality Control Supervisor will lead the QC analytical team, ensuring the highest quality standards are met in the development and manufacturing of new treatments for patients worldwide. This role requires a strong understanding of cGMP practices and the ability to mentor direct reports on scientific and regulatory principles.Key...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job SummaryCatalent is a global leader in the development and manufacturing of pharmaceutical products. We are seeking a highly skilled Senior Equipment Process Engineer to join our team in Harmans, MD. As a key member of our team, you will be responsible for introducing new biopharmaceutical products at our development and manufacturing sites.Key...


  • Harmans, Maryland, United States Catalent Inc Full time

    The Quality Control Manager is responsible for providing support and oversight to the Quality Control Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables as part of client's analytical implementation.Manage the OTL for analytical method implementation and support SMPs and Batch...


  • Harmans, Maryland, United States Catalent Inc Full time

    The Quality Control Manager at Catalent Inc is responsible for providing support and oversight to the Quality Control Team as they support the Quality Control and Batch Disposition departments, ensuring samples are tested on time and QC deliverables as part of client's analytical implementation.Manage the OTL for analytical method implementation and support...


  • Harmans, Maryland, United States Catalent Inc Full time

    About the RoleCatalent is seeking a highly skilled Senior Equipment Process Engineer to join our team in Harmans, MD. As a key member of our engineering team, you will be responsible for introducing new biopharmaceutical products at our development and manufacturing sites.The majority of the process will involve liquid formulations manufactured under...


  • Harmans, Maryland, United States Catalent Inc Full time

    Job Summary:Catalent Inc is seeking a highly skilled Senior Equipment Process Engineer to join our team. As a key member of our engineering team, you will be responsible for introducing new biopharmaceutical products at our development and manufacturing sites.This role involves onboarding new process equipment, working closely with production and development...


  • Harmans, Maryland, United States MSCCN Full time

    Job SummaryThe Manufacturing Scheduler will play a critical role in the Supply Chain organization, reporting to the Senior Manager, Production Scheduling. This position will lead the entire manufacturing scheduling process for an assigned production area, serving as the central source of information.Key ResponsibilitiesDevelop, update, and adjust the...