7 community care coordinator jobs found

Regeneron is currently seeking an Associate Director/Director for our Quality Control (QC) Technical Resources Chemistry team for in-coming component testing, functional testing for combination drug products and raw material testing. This role will be responsible for bringing new components, determining the qualification and testing strategy, the oversight of the QC method validation of the methods for incoming components including visual inspection, functional testing, compendia testing, and method transfer to or from other internal sites, partners companies, and contract manufacturing companies. As an Associate Director , a typical day might include the following: Support filling operations for any technical support. QC method validation and transfer processes. Maintain open communications with scientist including internal, partner and contract manufacturing organizations. Provide direction to Managers and scientist that support the method development, validation and...

Regeneron, located in Tarrytown, NY is seeking an energetic Process Development Engineer I to support technology transfer and business operations in the Technology Transfer & Logistics (TT&L) group within Preclinical Manufacturing and Process Development. In this role, you will lead production process transfer to support preclinical and clinical manufacturing at internal and external sites, as well as manage and coordinate a wide variety of departmental business operations. A Typical Day in This Role Might Look Like: Lead cross-functional teams to complete process transfer and establishment of production processes at internal and external clinical manufacturing facilities, with a focus on early-stage programs. Work to ensure the successful start-up of manufacturing production campaigns. Drive team cooperation to facilitate resolution of cross-functional issues and/or provide value-adding solutions. Ensure effective, accurate and timely communication...

Regeneron is currently looking for a Drug Product (DP) MSAT (Manufacturing Sciences and Technology) Engineer for our Device Assembly and Packaging team. This role will serve as combination device and secondary packaging design and development lead for biologic product packaging (clinical and commercial). Serve as a technical representative for CMO selection strategy, equipment qualification activities, and be hands on solving issues during technology transfer and cGMP start up. The MSAT team will strive to establish standard methodologies for technical support of cGMP manufacturing operations. As a DP MSAT Engineer, a typical day might include the following: Drives innovation in the area of device assembly, labelling and packaging by identifying the latest technological advancements and ensuring a creative environment and implementation aligning to business needs. Ensuring site to site consistency after the processes are optimally transferred, provide floor support during...

Regeneron is currently seeking an Associate Director to join our Downstream Sciences and Investigations (DSIG) team. The Associate Director- Process Sciences leads a lab based team responsible for the assessment of changes to raw materials and their impact to Manufacturing operations and product quality. The role also maintains awareness of industry and regulatory trends to manufacturing technologies and material sciences to assess and support implementation within IOPS to remain in the forefront of industry.   As an Associate Director- Process Sciences a typical day may include: Leads cross-functional teams in generating and analyzing data to assess raw material attributes for impact to new and existing manufacturing processes which include change notifications, secondary sourcing, raw material investigations, and impurity/byproduct/extractable risk assessments. Perform risk assessments for changes to raw materials to determine potential impact to the processes. Leads...

Regeneron is seeking a Process Development Engineer I as a full-time position to work in the Purification Development group within Pre-Clinical Manufacturing and Process Development (PMPD). In this exciting role you will be primarily involved in the design and implementation of viral clearance studies to demonstrate virus safety of biotechnology products throughout the product development cycle from Phase I clinical trials through commercial licensure. A Typical Day in The Role Might Look Like: Design and leads multiple viral clearance projects with supervision Develops and qualifies scale-down models for viral inactivation, chromatography and membrane filtration unit operations Travels to external laboratories (20 – 25%) to execute viral clearance studies in accordance with GLP Collaborates with cross-functional groups to coordinate study logistics Summarizes studies and results in electronic laboratory notebooks, technical reports, and regulatory filings...

Regeneron Pharmaceutical’s Analytical Chemistry Group is seeking a highly motivated Sr. Scientist to join our group. Sr. Scientists work with LC-MS technologies to guide and support development and characterization of therapeutic protein candidates and other modalities. We apply and solid understanding of various LC-MS platforms and applications to solve analytical problems. A Typical Day in the Role of Sr Scientist Might Look Like: Design, complete, and optimally communicate analytical characterization of biotherapeutics, including monoclonal and bispecific antibodies, Fc-fusion proteins, and other modalities (adeno-associated virus, mRNA, siRNA, etc.) to support drug discovery and development. Lead and deliver on characterization activities to elucidate product quality attributes like post-translational modifications, sequence variants, charge variants, size variants, and host cell proteins. Form and maintain inter-departmental collaborations to solve any potential drug...

The QA Validation Fill Finish team is hiring a Manager! As the Manager, QA Validation you will validate/qualify equipment, systems, and processes related to cleaning, sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures. In this role, a typical day may include: L eads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods, and other industry practices. Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and being responsible for Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, implementing validation protocols, and writing reports of validation...