Batch Record Reviewer

Summary:

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 (https://biologics.catalent.com/our-locations/north-america/baltimore-usa/) . 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 Batch Record Reviewer is responsible for providing support to manufacturing 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 manufacturing/MTO functions as needed. In this role, The Batch Record Reviewer 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, 7:00 pm to 7:00 am

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

• Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.

• 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

• Independently executes record review for completeness, accuracy and cGMP compliance and compile and report performance metrics for Batch Review and Release

• Contributes to process improvement of records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met

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

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

• Prepare reports right the first time (RFT) reports and keep upper-level management informed of progress as manufacturing reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management.

• Performs duties under limited supervision and according to standard operating and manufacturing procedures

• Collaborates within Manufacturing to resolve record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory

• Support on-the-floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.

• Perform tasks in a manner consistent with all Catalent policies including safety (EHS), quality systems and cGMP requirements

• Understand risks and delays to batch release and communicate appropriately

• Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs

• Participate in site and corporate quality and process improvement initiatives. Represent MTO on project teams and represent the Batch Disposition manufacturing perspective as needed

• Interact with stakeholders to support the development, manufacturing, testing, packaging, and release of cell and gene therapy products

• Other duties, as necessary

The Candidate:

• B.S. Life Sciences discipline

• +4 years’ experience within the biologic, biopharmaceutical, pharmaceutical or regulated industry

• +2 years’ experience in a Quality Assurance/Quality Control or Manufacturing function

• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines

• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

• Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish preferred

P osition Benefits:

• Defined career path and annual performance review and feedback process

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• 152 hours of paid time off annually + 8 paid holidays

• Competitive salary with yearly bonus potential

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

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.

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