The Manager will lead the upstream manufacturing team within the brand new state-of-the art biologics manufacturing facility located in West Chester, PA. This key role supports the development, qualification and overall success of upstream operations of Teva’s proprietary and biosimilar biologics pipeline. We are seeking a seasoned hands-on manufacturing lead to take responsibility for the upstream manufacturing team. The successful candidate will collaborate extensively with the quality assurance, quality control and the automation, equipment and engineering teams to develop manufacturing policies and procedures, participate in new equipment FAT, commissioning and qualification, develop manufacturing batch record and work instructions along with production SOP’s, and develop and support environmental monitoring strategies.
The management level position will be responsible for the success of upstream operations. This includes collaboration with internal development teams during technology transfer and supporting quality assurance with batch record review, deviation resolutions and Change Controls to facilitate rapid batch release. The position also requires expertise to identify, trouble shoot and implement improvements within a predominately single-use process train. The individual will write, review and ensure issuance of revised documents as well as review and approve executed required documents including, technology transfer reports, changeover checklists, batch documents, standard operating procedures, deviations and change controls, when necessary.