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Associate Director, Manufacturing (GMP)
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- AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNbased therapeutics.
- The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)- Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) - Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) - Amplify's Manufacturing Enablement Center.
- Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience.
- This role involves managing all aspects of manufacturing processes, from cell culture and gene editing to purification and formulation, ensuring adherence to regulatory standards and maintaining product quality and consistency.
- Execute manufacturing processes according to established SOPs, batch records, and work instructions for the production of cell and gene therapy products.
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