8684 Manager, Regulatory Affairs
Summary: The company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult […]
6970 Study Specialist II
Summary:The Company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.These conditions are often inherited, difficult to diagnose, progressively […]
9090 Manufacturing Execution System Recipe Author
Summary:Job duties will be performed on-site in Hillsboro, Oregon.The Team is supporting the Company’s Technical Operations (HTO) which is the commercial Make Assess and Release (MAR) and launch site for North America and Hillsboro Individualized and Cell Therapies (HIT) that is transitioning into a multi-product facility for development, clinical and […]
8910 Metrology Technician Coordinator
Responsibilities:The responsibilities for this position may include, but are not limited to:Review weekly Metrology calibration shipping / receiving workload and work with the scheduler to ensure the assigned schedule is accurate.Contact outside vendors to perform Standards calibrations, Standard repairs, equipment repairs, and to order parts, obtain shipping authorization / RMA […]
2109 Accounting Manager
SUMMARY:This Accounting Manager role is part of the U.S. Controllership team, reporting to the Associate Director, North America Accounting.This position is a backfill for our day-to-day accounting work while the existing team members dedicate their time to an enterprise-wide system implementation project.This temporary position will be at least one year […]
2113 Senior Vendor Laboratory Manager
Duties:Clinical Laboratory & Biospecimen Management (CLBM) is a group within Strategic Research and Development Operations (SRDO) that provides effective and efficient vendor oversight (operational, contractual, and financial) for Central and Specialty Laboratories involved in all stages of company’s clinical trials. CLBM is organized to focus on both Biospecimen Management and […]
1628 Medical Writer
Duties:The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. Responsibilities:Drafts and edits documents used for submissions including CTDs and […]
6561 QC Analyst I
Summary:Conduct routine and non-routine analysis of manufacturing environment and in process commercial products according to standard operating procedures.Responsible for collecting, processing and reporting data.Apply knowledge of good manufacturing practices and good laboratory practices on a daily basis.Compile data for documentation of test procedures and prepare reports for internal and regulatory […]
Computer System CSV Support
Summary:The IT OT Team is supporting Technical Operations which is the commercial Aseptic filling for Drug Product and launch site for North America and Individualized and Cell Therapies which is transitioning into a multi-product facility for development, clinical and commercial supply capabilities for individualized and cell therapies. What you’ll be […]
0545 Training Specialist II
Duties: The Company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory […]