Senior Specialist, QA Batch Disposition

Senior Specialist, QA – Batch Disposition

Position Summary

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 Sr. 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 2nd shift position, Monday - Friday 2pm - 11pm.

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 systems, including developing and producing reports using Microsoft Office (Excel)

• Requires the ability to produce results in a fast-paced environment to meet client deadlines

Pay

The anticipated salary range for this position in Maryland is $93,280 - $128,260 plus annual bonu