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Senior Director, Quality Assurance - Formulation And Fill
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Full-time
- Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help bring biologic treatments to our patients.
- As the Senior Director of Quality Assurance for Formulation and Fill at Catalent Biologics, you will assume a strategic leadership role, ensuring the highest standards of quality and compliance within our dynamic and fast-growing business, with a specific focus on formulating biologic drugs for sterile fill/finish processes.
- Assess and determine the most suitable sterilization strategy for biologic drug substances considering the instability of most biologics when exposed to heat, radiation, or chemicals.
- Emphasize the preference for aseptic manufacturing, particularly sterile filtration, for unstable biologic products.
- Highlight the challenges of using terminal sterilization methods for biologics, such as heat, radiation, or chemical exposure, and stress the advantages of aseptic manufacturing.
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