Senior Specialist, QA Batch Disposition

Senior Specialist, QA – Batch Disposition

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Our Gene Therapy facility, located at the University of Maryland (UMD) BioPark in the city of Baltimore, MD, specializes in upstream and downstream process development of viral vectors for clinical applications. Baltimore is a hub of national and international travel and communications and is also home to and near major universities and several federal agencies, including the FDA, USDA, NIH, Johns Hopkins University, and UMD Schools of Medicine. The. facility houses process development labs and CGMP cleanroom suites for Phase 1 and 2 programs focused on a variety of transformative technologies, including AAV and other viral vectors, vaccines, and oncolytic immunotherapies.

The Senior Specialist, QA – Batch Disposition is responsible for providing Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance and finished drug product. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed. In this role, the individual is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements.

This is a full-time on-site position, Monday - Friday 9am - 6pm.

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

• Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, SMPs, and product specific documents

• Interacts with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of cell and gene therapy products

• Independently executes batch record review for completeness, accuracy and cGMP compliance

• Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs

• Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities

• Act as QA reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management

• Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate

• Other duties as assigned

The Candidate

• Masters’ degree with minimum 2 years experience biologic, biopharmaceutical, or regulated industry. Scientific or Life Science discipline degree preferred OR Bachelors’ degree with minimum 4 years experience biologic, biopharmaceutical, or regulated industry. Scientific or Life Science discipline degree preferred

• 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

• Ability to quickly learn new and novel manufacturing processes supporting new clients

• Identification of problem areas affecting operations (knowledge/problem solving)

• Proficient technical and quality background related to pharmaceuticals

• Proficient with electronic system