The Technical Services Specialist is responsible for working on aspects of the technology transfer for nebulizer drug products. This would include working with Formulation and Analytical Development, Quality, Production and Regulatory to identify product and process criticalities and how to maintain them along with finding creative solutions to any roadblocks in the Transfer process.
This role is also responsible to maintain necessary timelines for the transfer and any associated ancillary activities.
The individual in this role is responsible for working on multiple projects simultaneously with lead scientist or minor supervision in a fast-paced environment. Aside from Technology Transfer activities, the position requires writing of technical documents to support, including protocols, reports, SOPs and technical assessments. The specialist is expected to work with other scientist to support process development within a team based environment.
This position will be responsible for participating in and leading interdisciplinary teams throughout the product lifecycle.
- 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 documents including master batch records, protocols and reports, SOPs, 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, technical discussions to support process development and filing timelines.
- Provide guidance and training to production employees on product specific criticalities.
- Support and monitor execution of Scale up, Exhibit and process validation batches with production team.
- Work with Cross-Functional team leads in order to identify opportunities for enhancements and champion projects which will improve overall site function.
- Work with development and site multidisciplinary project teams to optimize product transfers.
- 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.
- B.S in Pharmaceutical Sciences (or equivalent) required, M.S in Pharmaceutical Sciences (or equivalent) preferred.
- Minimum of 3 years in Sterile Product development with a focus on Technical Transfer or equivalent manufacturing experience.
- Inhalation product experience is a MUST.
- Experience in Blow-Fill-Seal technology