5 clinical specialist jobs found

We are currently looking to fill a Facilities Compliance Specialist (Technical Writer) position. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our Facilities Compliance Specialists ensure cGMP compliance for the Facilities Management Department. *This is an onsite position located in Rensselaer, NY* As a Facilities Compliance Specialist, a typical day might include the following: Acting as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance Managing and participating in Facilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner...

We are currently looking to fill a Principal External Manufacturing Specialist role. The External Manufacturing Principal Specialist provides technical and process support for all aspects of clinical and commercial parenteral drug product operations in the External Manufacturing Network. Coordinates all aspects of manufacturing operations including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in the monitoring of cGMP compliance at drug product contract manufacturers.   As a Principal External Manufacturing Specialist, a typical day may include the following: Serve as the primary Regeneron technical contact for select DP contract manufacturing sites concerning day-to-day activities. Liaison between Regeneron Quality Control, Quality Assurance, Supply Chain, Operations/Logistics Departments and contract manufacturers or business partners. Ensure the timely routing and review of all master manufacturing records...

Regeneron is currently looking for a Principal QC (Quality Control) Micro Specialist to join our Micro Tech Team. This position will specialize in in developing QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods. As a Principal QC Micro Specialist , a typical day might include the following: Identification, introduction, onboarding and initial qualification of alternative and rapid technologies applicable to microbiological assays and procedures. Become the SMEs of this technologies, assays and procedures. Coordinating Test Method validations, studies, and troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime. Builds processes where gaps have been...

The Sourcing Specialist will be responsible to support assigned categories and is a proven collaborator who can work with cross functional teams across Regeneron, locally, regionally and internationally. Essential Duties and Responsibilities include, but are not limited to, the following: Being accountable for supporting the definition and implementation of the assigned categories strategy to serve global and regional business needs as assigned. Working closely with stakeholders to support discussions related to the assigned categories and aligns category priorities with Procurement management and stakeholders. Supporting negotiations, supplier management activities, and stakeholder engagement activities for the Categories as assigned. Taking direction to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. Supporting Global Procurement by participating in organizational decisions in the...

Regeneron is currently looking for a QC (Quality Control) Micro Specialist to join our QC Microbiology Tech team. This is a lab based position that will specialize in developing new QC microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position will be actively involved in supporting Change Controls, data review, and compliance records for the microbiology verification team. Ensure departmental compliance to regulatory guidelines are maintained.  Drives continuous improvements for microbiological methods.    As a QC Micro Specialist, a typical day might include the following:   Leading Test Method verifications, designing studies, and assisting on troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity overtime.  Implement verified methods...