The opportunity
Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.
Located in West Chester, PA, Biologics CMC is a division of Teva Pharmaceuticals responsible for the development of biologics. The rapidly growing staff of Biologics CMC specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters. We currently are developing products in various stages of clinical development from IND through BLA filing. Drug Product Development (DPD) is a function within Biologics CMC dedicated to development of formulation, drug product manufacturing process, and process tech transfer to GMP manufacturing sites.
As a Scientist, the successful candidate will plan and execute studies, generate and organize data, author related technical documents in compliance with regulatory guidance and applicable policies. Additionally, the successful candidate will serve as subject matter expert (SME) and owner for multiple analytical instrumentation to support drug product development.
This position is located out of West Chester, PA and the person hired is required to be onsite 5 days a week
How you’ll spend your day
Design and execute the experiments based on QbD principles, evaluate quality of the data and work on ways to improve data analysis and presentation formats.
Represent DPD for selected project in cross functional project management teams, as needed.
Effectively collaborate with different CMC functions as well as other non-technical teams in Teva to facilitate routine operations.
Design and execute formulation and process development studies.
Perform routine analytical tests. Generate and organize data in compliance with regulatory guidance and applicable policies.
Author protocols, reports, technical documents and other relevant regulatory filings documents including IND/IMPD and marketing applications, as needed.
Assist in the set-up and maintenance of research labs including ownership of instrumentation, authorize instrument working instructions and serve as subject matter expert for the related analytical technologies.
Support manufacturing technology transfer, as appropriate.
