Sr. Manager, Regulatory Affairs Cell and Gene Therapy - Bothell

We are seeking a Sr. Manager to play a crucial role in interpreting and disseminating global regulations. · Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area o ...

The Quality Engineering team at Juno is responsible for providing Quality Assurance oversight of environmental validation and engineering documents. The position of QA Specialist - Environmental Oversight reports to the Manager, Quality Engineering. · Provide oversight of cleanro ...

The QC Chemist IV serves as a Method Transfer Lead within the QCSV group supporting method transfer validation and bridging activities for biopharmaceutical products. · Lead or support method transfer and validation projects. · Author review protocols reports technical documentat ...

The incumbent is responsible for supporting the operations in our cGMP clinical manufacturing site producing plasmids, viral vectors, and autologous cell therapies. · This role executes manufacturing operations safely, adheres to cGMP and SOPs. · ...

This is a QC expert within the QCSV group responsible for method transfer and/or validation to ensure compliance with cGMP and regulatory expectations. · ...

About the role method transfer lead scientist is a qc expert within the qcsv group responsible for ensuring that analytical methods are transferred and validated according to cGMP and regulatory expectations. · ...

The Learning Management System (LMS) Administrator will manage and coordinate training events and record and control training information for the Learning Management System (LMS) · ...

The Learning Management System (LMS) Administrator will manage and coordinate training events and record control of training information for the Learning Management System (LMS). This position reports to the Quality Training Lead. · LMS Administration · Record control of training ...

BioLife Solutions is a leading developer of cell and gene therapy bioproduction tools and services. The company welcomes applications to join its dynamic team in a performance-based environment where authentic communication and treating colleagues with respect are required. · ...

The Learning Management System (LMS) Administrator will manage and coordinate training events and record and control training information for the Learning Management System (LMS). This role reports to the Quality Training Lead. · ...

The incumbent supports operations in our cGMP clinical manufacturing site producing plasmids,viral vectors,and autologous cell therapies · ...

The Learning Management System (LMS) Administrator will manage and coordinate training events and record control of LMS training information. · LMS Administration · Record control of LMS training information with input from users... · ...

The Fountain Group is currently seeking a Quality Control Chemist for a prominent client of ours. · This position is located in Bothell, WA.Support Project Lead for method transfer and/or validation internally and externally for assigned program(s). · Author or review protocols a ...

The position of Senior Scientist involves leading method transfer and validation efforts within the QCSV group. The individual will ensure compliance with cGMP and regulatory expectations. · Support Project Lead for method transfer internally. · Author protocols for method valida ...

The incumbent is responsible for supporting the ongoing operations of the Manufacturing, Science and Technology (MSAT) team within the manufacturing site. · This role will primarily be responsible for real time process and equipment troubleshooting and critical manufacturing supp ...

Leading pharmaceutical company looking for an experience QC Method Validation & Transfer Coordinator. · ...

This Senior QC Scientist will lead method transfer and/or validation for assigned programs. They will support project leads internally and externally, author or review protocols and reports, plan and track deliverables. · ...

A leading pharmaceutical company is looking for an experienced Quality Control Chemist with a Bachelor's degree and 8-10 years of experience in pharmaceutical/biological drug product development, analytical chemistry and/or QC in a regulated biotechnology, pharmaceutical company. ...

This individual contributor has good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation comply with cGMP and regulatory expectations. · Support Project Lead for method transfer and/or validation internally and externally ...

The individual in this role will be responsible for supporting the ongoing operations of the Manufacturing, Science and Technology (MSAT) team within the manufacturing site. · ...