- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Sr. QC Data Reviewer as part of the Quality team based in Raritan, NJ.Role OverviewThe QC Data ... Reviewer is an exempt level position responsible for reviewing...operations in a controlled GMP environment.Key Responsibilities Perform peer review /approval of laboratory data including but not limited to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QC Microbiology Data Reviewer is an exempt level position with responsibilities for...and commercial operations in a controlled cGMP cleanroom environment.Create, review and approve relevant QC documents, logbooks, SOP's and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders.Job Summary: This position manages multiple biological developmental projects with supervision, including working with contract ... Team for late stage projects. This position manages multiple biological developmental projects with supervision, including working with contract manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Manufacturing, and Controls) activities of the portfolio small molecule and biological drug products consistent with the company goals; specifically, for the ... on Harmonization (ICH), and other applicable regulations. This includes preparation, review , and approval of CMC documentation for BLA Supplements (PAS, CBE-0,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …proper materials, parts and spare parts are identified and availablePerforms work review , approval and close out of work orders, including management of third-party ... peopleJob duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.Key Relationships: Ability to interact with all… more
- Eisai, Inc (Raleigh, NC)
- …and business acumen to:Direct/manage assessments and resolution of technical issues.Draft, review and approve relevant technical documents, such as change controls, ... laboratory testing in a cGMP environment.Requirements Graduate level degree in biological sciences or related subject required. Ph.D. highly preferred with… more
- The George Washington University (Washington, DC)
- …impact the research enterprise. In the performance of duties, the position will review , research, and interpret changes, trends and new developments related to areas ... procedures to implement and operationalize related initiatives; ensure regulatory review processes are standardized; develop strategies to enable implicated research… more
- Sonora Quest (Sterling, CO)
- …May be responsible for the collection, receipt, and processing of biological specimens into the laboratory.Performs all functions according to established policies, ... criteria to qualify:Associate degree in a laboratory science (chemical or biological science) or medical laboratory technology from an accredited institution,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and forecasting for commercial and IMP relevant activities and QA batch review and release process as necessary.Complaint and Recall Programs Establishment: Manages ... external stakeholders to complete deviations in a timely manner.Development and Review of Standards and Procedures (SOPs) and Training Activities: Responsible for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide guidance and determine immediate path forward for manufacturing issues.Real time review of all documentation, and reporting, in support of process unit ... operations, in accordance with Good Documentation Practices (GDP). Review , revise, or draft Standard Operating Procedures (SOPs).Support on process aseptic process… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate analysis results to customers.Perform statistical analysis to support biological and vaccine clinical assays.Author and review detailed ... and regulatory agencies.--Engage in AI/ML and statistical methodology research.Author and review detailed statistical reports, as well as respond to inquiries from… more
- Sonora Quest (Fallon, NV)
- …and may be responsible for the collection, receipt, and processing of biological specimens into the department, preparation of samples for analytical testing, and ... to threat of exposure to blood and body fluids, chemical, electrical and biological hazards. Ability to distinguish colors and to take direction and assimilate… more
- KFS-LLC (Huntsville, AL)
- …of unique and/or complex environmental problemsProvide technical reviews and review comments for environmental studies and reportsPrepare environmental scopes of ... for DoD and other federal agenciesBachelor's degree (or higher) in biological sciences, cultural resources, natural resource management, or other scientific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to successfully transfer process to cGMP facility to manufacture products.Create, review and approve relevant QC documents, SOP's and WI's.Ensure microbiological ... key critical inputs to site environmental monitoring program.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for execution and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to successfully transfer LVV manufacturing process to cGMP facilityCreate, review and approve relevant QC documents, SOP's and WI's5Ensure microbiological ... key critical inputs to site environmental monitoring program.Perform peer review /approval of laboratory dataUtilize electronic systems (LIMS) for execution and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory dataUtilize electronic systems (LIMS) for execution and ... documentation of testingCreate, review and approve relevant QC documents, SOP's and WI'sPerform...of 4 years relevant work experience, preferably within a biological and/or pharmaceutical industry is requiredExperience in a Quality… more
- Sonora Quest (Fallon, NV)
- …May be responsible for the collection, receipt, and processing of biological specimens into the laboratory.Performs all functions according to established policies, ... in medical laboratory science/medical technology, ORBachelor's degree in chemical or biological science (transcripts may be reviewed to determine eligibility) AND… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …of tumor samples and tissues from mice and NHPAnalyze, summary, review and present dataParticipate in assay development and qualificationMaintain good documentation ... investigational studies with various techniquesRequirements Ph.D. or Master degree in biological sciences (Immunology, cell biology and cancer biology) or related… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …transfer process/analytical testing to cGMP facility to manufacture products.Perform peer review /approval of laboratory data. This individual will work closely with ... required.A Minimum of 2-4 years relevant work experience, preferably within a biological and/or pharmaceutical industry is required Experience in a Quality Control… more
- Catalent Pharma Solutions (Harmans, MD)
- **Batch Record Reviewer ** **Summary:** _Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The ... AAV and other viral vector-based therapies and vaccines._ The **Batch Record Reviewer ** is responsible for providing support to manufacturing for GMP documentation… more
