Technology Transfer Scientist 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. This hire will be expected to work with Formulation and Development, Production, Regulatory and Quality Teams to support the commercialization of products in a team environment.
Key Responsibilities include:
- Support and resolve manufacturing or analytical issues for inhalation products. Provide technical support as a SME to cross-functional teams during development, commercial launch or problem solving for a given drug product.
- Provide technical support and documentation review for technology transfer ongoing projects.
- Key role in product & process optimization in terms of cost reduction, cost saving, improvement of process efficiency and Operational excellence.
- Conceive, plan, design and conduct advanced independent research in process or product development. Capable of taking complete scientific responsibility for a project. Functions independently to troubleshoot and solve difficult technical problems.
- Participates/ Interacts with highly diversified cross functional team of professionals to ensure that all aspects of projects are completed on time, within budget, and meet the highest scientific, regulatory, quality, marketing and commercial standards.
- Ability to gather data together, perform basic statistical analysis in order to extract knowledge, trends, for the performance evaluation of products and processes.
- Develop and communicate product transfer plans, cost estimates, business plans, timelines and contingency plans for responsible projects in areas of Vendor Development/ Gross Margin Improvement/ Supply chain Optimization
- Establishing, maintaining and fostering good working relationships with customers including Established Product Operations, commercial divisions.
- B.S./M.S. in Pharmaceutical Sciences
- Five (5) years in Sterile Product development with a focus on Technical Transfer and commercialization of Inhalation products.
- Strong analytical and product development work experience is required to include a broad understanding of scientific concepts and analytical testing requirements per USP, GMP and FDA guidelines