The Manager, QC Virology oversees the QC Virology team, ensuring GMP-compliant laboratory operations in accordance with regulatory guidelines. This role involves direct management of PCR, RT-PCR, qPCR assays, Adventitious Virus (AVA) testing, and Mouse Minute Virus (MMV) testing. As a technical subject matter expert, the Manager provides support for troubleshooting complex investigations and optimizing laboratory systems while ensuring accurate documentation and compliance with GMP standards. Additionally, this role represents the QC Virology team during customer and regulatory audits and foster the development of team members through effective leadership.

This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

The Sr. Automation Engineer 2, DSM MES provides support to Drug Substance Manufacturing (DSM). 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 leads projects and handles complex changes while coordinating with other internal and external groups.

The QC Chemistry Sr. Analyst 1 works with limited direction to execute QC analytical chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The QC Chemistry Sr. Analyst 1 adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The role is primarily responsible for executing routine analytical methods in support of manufacturing, supporting laboratory execution of analytical method transfers and validations, and training other QC Chemistry laboratory associates. The ability to effectively communicate and function in a fast-paced, highly  technical environment is essential to success.

The Sr. Specialist 2, QC Instrumentation manages routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program with minimal supervision. This role ensures compliance with Data Integrity standards in alignment with regulatory guidelines and company policies. The Sr. Specialist executes and monitors the performance of routine maintenance, performs periodic reviews to ensure continued compliance, and leads the identification and correction of deviations. The role provides guidance to stakeholders and addresses issues related to QC analytical instruments. It also includes periodic on-call and weekend support as needed

The Project Manager 2 is responsible for collaborating with internal and external stakeholders, including but not limited to Environmental, Health & Safety(EHS), Maintenance, contractors, vendors, and clients. This role is responsible to handle administrative aspects of the project from start to completion, track and monitor the project status and milestones, and ensure projects meets all standards, timelines, and budgets.