- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, New Jersey. Role Overview ... The Lead QC Microbiology Data Reviewer is an exempt level position with responsibilities for...intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in… more
- BioAgilytix (Durham, NC)
- …Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical ... services . We are tirelessly committed to our customers by...with your knowledge of plate-based assays, cell work, gene therapy and more.We are looking for candidates who have… more
- BioAgilytix (Boston, MA)
- …Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical ... services . We are tirelessly committed to our customers by...an Analyst II/III to join our Cell & Gene Therapy team. The ideal candidates will have scientific lab… more
- Option Care Health (Dublin, OH)
- …or remotely, the Pharmacy Resident assists in the on-going support of field clinical services , and supervises the Drug Information Service . At the field office, ... Care Health, Inc. is the largest independent home and alternate site infusion services provider in the United States. With over 6,000 team members including 2,900… more
- Aequor (Seattle, WA)
- …supports the cGMP Document Control operations for the Client Cell Therapy Above-site organization, including the document approvals, document change control process, ... periodic review and system reporting. Duties/Responsibilities: Primary responsibilities include: Managing...include: Managing an electronic document system for the Cell Therapy Above-Site which includes reviewing and approving document change… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process, equipment, and associated deviations and investigations within a cell therapy manufacturing plant to support both clinical and commercial requirements in ... provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement activities. They will be… more
- Insmed Incorporated (Bridgewater, NJ)
- …Patient Advocacy, appropriate access solutions to help enable timely patient access to therapy Partner with IT and other Patient Services Leadership team members ... you will be a key member of the Patient Services Leadership Team, responsible for leading the pull-through of...the pull-through of the Patient Support Program design and service offering. Specifically, the candidate will have responsibility to… more
- Concorde Career Colleges, Inc. (San Bernardino, CA)
- Overview Respiratory Therapy - Director of Clinical EducationOur Mission:At Concorde Healthcare Career College, we are dedicated to making a difference in the lives ... availability of clinical sites for the educational experience of our Respiratory Therapy students. As a mission-driven institution, we are committed to impacting the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP ... resolution for manufacturing issues Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints … more
- Catalent (Harman, WV)
- …organization for Catalent Maryland. Catalent Maryland is a commercial Gene Therapy manufacturing facility with ten suites actively operating and eight additional ... function in vendor selection and negotiation to obtain most favorable pricing, service , and termsIs responsible for driving performance improvements in the key… more
- Merck & Co. (Rahway, NJ)
- …of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.-- ... design controls process and design history file development.Author and review relevant portions of the regulatory submissions (INDs, IMPDs,...to have a minimum of twelve (12) months of service in current position prior to applying for open… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in ... many stakeholders. Support other quality systems activities, as needed. Support drafting, review and approval of standard operating procedures and any other required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with various Technical Operation ... functions in support of personalized cell therapy production through safe and compliant manufacturing operations according...and spare parts are identified and available. Performs work review , approval and close out of work orders, including… more
- Novo Nordisk Inc. (OH)
- …and Medicaid benefit designs, Payer Coverage, Prescription Coverage Requirements, Step Therapy , Coverage Gap, Copays, and Deductibles and the impact on customer ... by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records. Qualifications Bachelor's or equivalent degree, and/or Pharm… more
- BioAgilytix (Boston, MA)
- …Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical ... services . We are tirelessly committed to our customers by...project updatesAdvise clients on Biomarker assay best practicesAuthor and review documents (plans, SOPs, reports)Data analysis and interpretationWork collaboratively… more
- Aequor (Seattle, WA)
- …Management System (LMS). The position will report to the Global Cell Therapy Quality Training Lead REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Must have ... the LMS within 1 business day of receipt and retained per procedure. Review training form submissions for adherence to good documentation principals, accuracy and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP ... personnel to provide guidance and determine resolution for manufacturing issues. Review critical level investigations and supporting corrections and CAPAs. Lead… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for managing the technical transfer and clinical/commercial manufacture of cell therapy products in our external manufacture organization. He/she will be the ... timely execution of the production plan at the CMO's. Leads the management review process with CMO's based on agreed KPI's Drives and steers continuous improvement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …specialists and partner with cross functional areas in support cell therapy production for clinical and commercial patients. Key Responsibilities Supervises an ... with all cGMP, company policies, and appropriate regulatory standards. Performs work review , approval and close out of work orders, including management of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Environmental Monitoring sampling of the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled ... to successfully transfer process to cGMP facility to manufacture products. Create, review and approve relevant QC documents, SOP's and WI's. Ensure microbiological… more
