Teva Branded Pharmaceutical Products R&D, Inc. is seeking a Sr. Research Associate (West Chester, PA) to participate in cell culture process development for early and late stage development projects under general supervision.
- Develop upstream cell culture process for Teva’s biologics pipeline and generate material for pre-clinical study.
- Perform routine cell culture maintenance and seed culture expansion based on study plans at various scales, including shaker flasks, Ambr15, Ambr 250, 10, 50, 100, and 200L bioreactors.
- Perform equipment set-up, sterilization, daily operation, sampling, and in-process tests. Record experiment results in batch records and lab notebooks in compliance to good documentation practice and perform data analysis as needed.
- Design and conduct experiments for upstream process development.
- Develop experimental plan and execute cell culture and/or harvest studies in laboratory.
- Evaluate new technologies to improve the efficiency of biologics manufacturing process and reduce cost of goods.
- Design fit-for-purpose cell culture experiments according to the stage of development, execute the runs in process development lab, analyze performance data and write technical reports, and prepare presentation for management.
- Critically analyze complex data, interpret and integrate experimental results with project objectives, and write technical reports in timely manners. Interact cross-functionally with downstream process development, Drug Product, Analytical, Facilities, Quality Control, and other internal and external functions to support successful process development.
- Support cGMP (current Good Manufacturing Practices) clinical manufacturing campaigns in Biologics Manufacturing Facility.
- Expand the technical capabilities of Process Development group, by offering expertise in areas such as technology development, platform development, or using a literature precedent.
- Maintain and troubleshoot laboratory equipment, coordinate calibration, and manage raw material stocks and supplies in collaboration with relevant internal groups.
- Manage USP projects for timeline driven deliverables including technical protocols/reports, effective information flow, and issue resolution.