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Position: Technical Services Scientist (OSD)

 

Responsibilities include but not limited to: 

  • Perform scale up/development work associated with site transfers of drug products. 
  • Work with CFT to identify criticalities to transfer and identify development requirements to support  
  • Work on process development  
  • Activities of multiple projects simultaneously. 
  • Write and review technical documents including formulation development protocols and reports, SOPs, specifications, and other necessary technical documents.  
  • Work with R&D and Validation on process development to support from scale up to commercial validation.  
  • Participate in multidisciplinary project teams through the complete product transfer to support the filing cycle.  
  • Organize, and lead technical discussions to support process development and filing timelines. 
  • Provide guidance and training to production employees on general and product specific criticalities. 
  • Work with Cross-Functional team leads in order to identify opportunities for enhancements and champion projects which will improve overall site function.  
  • Work to minimize site costs by finding efficiencies and synergies in the Technology Transfer process. 
  • Work with development and site multidisciplinary project teams to optimize product transfers for efficient Commercialization.  
  • Remain abreast of current regulatory requirements and newest technologies to shorten deliverable timelines and increase the efficiencies of process while maintaining the most current compliance practices.
  • Participating in and leading interdisciplinary teams throughout the product development cycle
 

Education: 

  • B.S in Pharmaceutical Sciences or equivalent or higher  

Experience: 

  • Minimum of 5 year in Solid Oral Dose product development with a focus on Technical Transfer and commercialization. 
Other
  • Secondary Other Category
Oral Solid Dose, Tech Services Scientist
  • Bachelors
  • Full Time Direct Hire
Location 28110, North Carolina
Start Date 4/15/2019