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Duties/Responsibilities | |
1 | Review of late-stage Product Development efforts in formulation, process robustness and manufacturing controls, providing input for technology transfer or process validation required to achieve a successful transition |
2 | Provide support in the form of expertise and document ownership for each stage of development in the pharmaceutical development process as needed and product lifecycle activities within the Commercial Blue Ash Facility |
3 | Author manufacturing, packaging and in-process sections of Investigational New Drug (IND), New Drug Application (NDA) and Amended New Drug Application (ANDA) filings and supportive documents as directed |
4 | Review regulatory filings and generate needed documents for support |
5 | Perform risk analysis and assure appropriate parameters are evaluated with the needed statistical approach to associated testing for justification and support of critical process parameters and quality attributes |
6 | Collection and statistical evaluation of raw material critical quality attributes (CQA), in-process testing and critical process parameters (CPP) for continuous process improvement and annual report evaluations |
7 | Author and review technical memos, qualification/validation protocols and reports for cleaning and manufacture of drug product to demonstrate a state of control |
8 | Execute sampling and testing as needed for Technical Services protocols and Blue Ash, OH facility intermediate testing |
9 | Author and review SOPs (standard operating procedures) for production where the introduction of new products or processes are being addressed |
10 | Project management as delegated for technical transfer and continuous improvement efforts within Aprecia |
11 | Provide leadership and support for next generation equipment design. Includes Process Analytical Technology (PAT) design and implementation, powder dosaging, 3D printing, liquid delivery systems, and transport system technology |
Full Time
Pharmaceutical
$99k-116k (estimate)
08/24/2022
06/20/2023
aprecia.com
EAST WINDSOR, NJ
100 - 200
2004
Private
PAT ZAFARINO
$5M - $10M
Pharmaceutical
Aprecia Pharmaceuticals develops, manufactures and commercializes precision drug delivery systems and other related products.
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