The Manufacturing Specialist 2, SAP performs manufacturing support activities to ensure compliant and reliable production. This role focuses on aspects of recipe configuration and troubleshooting related to Systems, Applications, and Products in Data Processing (SAP) material transactions. This manufacturing facility will be 24/7 operational and the role may require flexibility with working days and/or nights and shift rotation.

Director, QA Drug Substance Operations    Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance...

The QA Engineer, DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation. 

The Associate Director, QA for Materials, Supply Chain and QC will be responsible for the supervision of the Quality teams supporting release of materials, Supply Chain functions including warehouse as well as providing Quality oversight for the QC function via supervision ensure that materials released are tested in accordance with GMP regulations. Provides QA support for approval of specifications, documentation, reports, deviations, and changes coming from the QC function. Assures product compliance through Quality systems and effectively ensure initiatives that promote a robust Quality Culture within Quality function and for supporting functions. Proactively engage with the organization...

The Automation Engineer 3, DSM Upstream will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role focuses on supporting the delivery of DeltaV logic for Upstream process areas including Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest.