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Tech Transfer Specialist - Full-time / Part-time
| Hours | Full-time, Part-time |
|---|---|
| Location | North Smithfield, RI North Smithfield, Rhode Island |
About this job
This position will assist in technical transfer of new or existing drug substance manufacturing processes to external manufacturing companies (CMOs). Responsible for providing strong scientific logic for all aspects of technology transfer; process fit analysis, process validation, and process troubleshooting to drug substance manufacturing activities at external facilities worldwide. Responsibilities also include providing support for regulatory submissions related to clinical and commercial products.
Principal Responsibilities
* Support technical transfer process to external CMOs in Europe. This includes continuous communication with Quality Assurance, Quality Control, and TMS teams to ensure efficient tech transfer of Company's commercial and clinical drug substance manufacturing activities.
* Provide technical support for technology transfer teams
* Support development, maintenance and continuous improvement of process validation program for drug substance manufacturing processes. Provide technical input to Process Development for defining the process control strategy for new processes
* Ensures open communication and effective collaboration of all involved functions and external parties
* Review technical documents for regulatory agency submissions
* Support the TT Manager & FTE Engineer as they travel to CMO for on site technical support of engineering and validation batches
* Support deviation root cause analysis and product impact assessment
* Support CMC preparation documentation including validation for filing
About Aerotek:
Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .
Aerotek is acting as an Employment Agency in relation to this vacancy.
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