0821 MES Training and Change Lead
Description:The Hillsboro Innovative Therapies (HIT) team is at the forefront of bringing new medical advancements from development stages to commercial manufacturing.We work with cutting-edge technologies such as individualized DNA/RNA therapies, cell therapies, and stem cell therapies.As a member of our Manufacturing Execution System (MES) team, you will have the opportunity […]
0803 Device and Packaging Development Lab Engineer
Summary:The Device Development Lab Engineer will play a crucial role in our device development lab, focusing on becoming an expert with the lab’s equipment and technologies. The individual will be responsible for using lab technologies to develop, improve, and validate automated or semi-automated test methods and qualifying computerized systems. This […]
0802 Device and Packaging Development Lab Technician
Summary:The Device Development Laboratory Technician will play a critical role in ensuring the quality and safety of life-changing medical devices and combination products.The job consists of essential physical testing for R&D, verification, complaint investigations, and stability programs within a cGMP environment. Responsibilities:Foster a collaborative and positive team environment through clear […]
4116 Contract Operations Analyst
Duties:The Contract Operations Analyst (CW) is responsible for helping to manage the contracting process and will act as the main point of contact for the Global Sourcing & Procurement (GSP) organization, our Managed Services Provider (MSP), and business stakeholders to ensure contracts are executed timely and accurately.This position also includes […]
9152 Senior Manager, Global Medical Information
Summary:The Real-World Evidence Leads are part of the Medical Evidence Generation function comprised of subject matter experts in evidence planning, study design and data interpretation.The function works to drive excellence in evidence planning and implement novel study design approaches to generate robust evidence to enhance understanding of unmet medical needs; […]
8511 Director, Business Development
Description:The Associate Director Safety Science performs signal detection activities, prepares aggregate safety reports, reviews ICSRs, and works with cross-functional team to evaluate safety signals. Scope:Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving the Company’s products to ensure accuracy of ICSR MedDRA […]
3632 Procurement Operations Analyst
Remote Summary:The Procurement Operations Analyst (CW) is responsible for helping to manage the indirect procurement process and will act as the main point of contact for GSP, our Managed Services Provider (MSP), and business stakeholders to ensure purchase requisitions, change orders and receipts are executed timely and accurately.This position also […]
8547 Global Study Operations Manager
Responsibilities include but are not limited to:Overall study execution oversight.Provide leadership, guidance, and direction to GSO staff assigned to studies.Lead cross-functional Study Execution Team (SET) meetings.Collaborate with cross-functional study members to drive and execute on study deliverables, documents, and plans.Proactively identify, manage, and communicate cross functional study issues, risks and […]
0789 Associate, QA Frontline
Duties:Provide on-the-floor QA oversight and support manufacturing operations.Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations.Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations.Represent QA in support of deviations including active participation in Root Cause Analysis […]
0392 Contracts Associate
Duties include:This role will support the company’s Legal Department and business partners by drafting, negotiating and tracking a high volume of contracts.Researching prior contracting relationship with contracting parties.Drafting, primarily from templates, multiple contract types including Non-Disclosure Agreements, Master Service Agreements, Amendments, Scopes of Work, and Change Orders, using ARIBA and […]