Sr. Manager Drug Product/Formulation for a Rapidly Growing Biotech Company
* Fully REMOTE, Company based in New Jersey,
* Competitive Salary + Benefits
The Sr. Manager Drug Product will have the following Responsibilities:
* Providing technical leadership and operational oversight of drug product formulation and manufacturing activities across all phases.
* Manages the development and implementation of patient-centric drug products, with scaleable and robust manufacturing processes across the different stages of development
* Manages technical transfers and implementation of manufacturing processes at third party service providers.
* Work with Quality Assurance and Regulatory Affairs to assure compliance with applicable GxP and global regulatory requirements
The Ideal Candidate will have the following skill set:
* Master's or Ph.D. in a related field
* 6+ years' experience doing formulation of Liquid and/or lyophilized drug products
* Prior experience leading Process Performance Qualification (PPQ)
* Hands on experience authoring NDA/BLA submissions
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