This position is responsible for working on all aspects of the technology transfer for sterile drug products, specifically Blow-Fill-Seal (BFS) and Inhalation 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 minor supervision in a fast-paced environment. Aside from Technology Transfer activities, the position requires writing and reviewing of technical documents to support, including protocols, reports, methods, specifications, SOPs and technical assessments. The Scientist is expected to work with Development 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 Cross Functional Teams (CFTs) 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.
- B.S in Pharmaceutical Sciences (or equivalent) required, M.S in Pharmaceutical Sciences (or equivalent) preferred.
- Minimum of 6 years in Sterile Product development with a focus on Technical Transfer and commercialization. Inhalation product experience is a MUST.
Our Company is an Equal Opportunity Employer committed to fostering diversity in the workplace, both in its employee workforce and in Company leadership. (minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity)