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