Ensure successful delivery of GMP material in partnership with Supply Chain, Quality and supporting functions by providing technical oversight of manufacturing batch execution, deviation management, troubleshooting, and batch release.

When needed, independently perform manufacturing of uniQure's therapeutic products and ensure this is realized and documented according to the highest industrial and GMP quality requirements.

0-3 years of relevant GMP experience in a pharmaceutical/biotech company, with experience working within a quality system and regulated GMP environment. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.

Skills: Quality control, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.

This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities.

Reporting to the Senior Director of Drug Substance Process Development and Manufacture, the Senior Manager, Upstream Process Development and Manufacture will be responsible for managing and supporting the upstream development and manufacturing activities of late-stage programs, including phase 3 process development, tech transfer, GMP manufacturing, on floor support, process characterization, process validation and BLenabling studies.

Basic understanding of Good Manufacturing Practices (GMP) and Quality System Regulations (QSR) The Quality Specialist will serve as QC Inspector Back-up. The Quality Specialist will support the Quality Systems such as: Audits, CAPA and Management Review.

Participate in complex projects, operational excellence initiatives, and quality systems improvements. Maintain GMP compliance and operational readiness of QC areas, ensuring adherence to industry standards.

The Associate Director (AD), Quality Systems and Documentation will maintain and continually improve the global Agenus electronic Quality Management System (eQMS) platform and enable compliant electronic and paper-based document control and archiving for the Agenus Enterprise Quality Management System (QMS.

Job Title: Quality Control Inspector I. Assist Quality Engineering with process and product validation testing. Must Have: Mechanical tester experience - Instron or MTS, gage experience.

MUST HAVES - mechanical tester experience - Instron or MTS, gage experience. Mechanical inspection experience (Tensile testing, peel testing, Instron or MTS equipment or equivalent) required. Calipers, micrometers, blueprint/artwork reading, etc.

The Supervisor Quality Assurance supports the successful manufacturing of parenteral pharmaceutical products by overseeing Quality Assurance Specialists and Sr. Specialists, coordinate QA team activities across shifts on day-to-day basis, and ensuring activities meet all regulatory and internal GMP requirements.

Strong knowledge of quality management systems (QMS), industry regulations, and standards (ISO, GMP, FDA, etc. Overseeing the implementation and maintenance of quality management systems (QMS), including ISO certifications and other relevant industry standards.

Knowledge of GMP and pharmaceutical industry best practices. Execute routine and non-routine testing to support manufacturing, validation, and development studies, including drug substance and drug product samples, stability testing, and various protocol studies.