Senior Specialist, Batch Disposition
2 weeks ago
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.
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