- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Lab Oversight Specialist as part of the Quality team based in Raritan. Role ... OverviewThe QA Lab Oversight Specialist role is an exempt level position...the site Quality Control laboratories responsible for testing of pre- clinical , clinical , and commercial stage CAR-T cellular… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... with the scientific community to influence the field.BPR&D includes three lab -facing technical functional areas: Process Cell Sciences (PCS), Upstream and Downstream… more
- BioAgilytix (Boston, MA)
- …or Medical Laboratory Scientist (MLS) through the American Society for Clinical Pathology (ASCP) or equivalentNot less than five (5) years' experience of running ... BioAgilytix Diagnostics is CLIA-certified, CAP-accredited, New York State licensed clinical diagnostic testing facility providing esoteric testing services to the… more
- Merck & Co. (Lower Gwynedd, PA)
- …bioanalytical vaccine immunogenicity assays to support regulated preclinical and clinical vaccine development. The individual will be responsible to contribute ... with limited supervision to all hands-on laboratory aspects of bioanalytical assay development, qualification/validation, technology transfer, and/or… more
- Merck & Co. (Rahway, NJ)
- …at the Rahway NJ facility. This position will be located in the Prep Lab facility which is responsible for interfacing with scientists who are manufacturing drug ... substance to support early clinical studies, scaling up new chemistries, and exploring new...the Specialist level is a member of the Prep Lab team and will be responsible for working directly… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …includes hiring, development and performance management of staff, reviewing/approving laboratory test data, developing and implementing QC procedures and methods, ... supporting laboratory investigations and ownership of various QC department projects.Key...related to the manufacturing of autologous CAR-T products for clinical and commercial operation in a Controlled cGMPenvironment.Be responsible… more
- Merck & Co. (Rahway, NJ)
- …(small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The ... as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot...development and seamless tech transfer to commercial sites. Prep Lab Area :- The Prep Lab is… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... with the scientific community to influence the field.BPR&D includes three lab -facing technical functional areas: Process Cell Sciences (PCS), Upstream and Downstream… more
- Merck & Co. (Lower Gwynedd, PA)
- … clinical applications. Familiarity with Regulated Bioanalysis and Good Laboratory Practice (GLP) is strongly desired. Demonstrated supervision and mentorship of ... successful candidate will be to design and develop immunology-based preclinical and clinical assays for our vaccines pipeline. The individual will be responsible to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to near ... cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams, Central &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to accelerate and expand that transformation. At Legend Biotech, we are excited to bring clinical trials to patients in our pursuit of a cure. While we are focused ... understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.Proficient with using… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross-functionally. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has ... managing people required7 or More Years managing initiatives requiredCompetenciesEnd-to-end clinical trial experience directing/overseeing data management services and deliverables… more
- Merck & Co. (South San Francisco, CA)
- …This position requires high level of motivation and dedication to lab experimentation with excellent comprehension of molecular biology, cell signaling pathways, ... (BS) or 5-7 (MS) years respectively of relevant professional laboratory research experience.Specific Responsibilities:Employ innovative molecular and cell biology… more
- Merck & Co. (Rahway, NJ)
- …complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of biologics active pharmaceutical ... and the passion for mentoring and working along others in a laboratory setting.- Applicants must have effective organizational and multi-tasking skills, have… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively ... to implement a quality system in accordance with 21CFR part 58 (Good Laboratory Practice (GLP), and other global regulatory authority requirements, and industry best… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …techniques and procedures. Procedures include, but not limited to clinical diagnostics, sample collection, administration of drugs or therapeutics, anesthetic ... given preference. Experience and/or certification (ie, ALAT, LAT, LATG) in laboratory animal research is desirable. Candidate must have a demonstrated understanding… more
- Aequor (South San Francisco, CA)
- …to develop and execute innovative biomarker and diagnostic strategies to drive clinical development through all phases of the portfolio and conduct foundational ... disease-oriented translational research to maximize our scientific and clinical impact. We are seeking a dedicated, experienced, and independent contract Scientist 3… more
- Insmed Incorporated (San Diego, CA)
- …ranging from purification development and optimization, process characterization and clinical manufacturing support. As part of this collaborative group, your ... position.ResponsibilitiesExecute technical strategies for purification process development to support pre- clinical and clinical programs at all development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position responsible for reviewing all data produced by the Quality Control Lab during In-Process and release Drug Product QC Testing, related to the ... manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key Responsibilities Perform peer… more
- Aequor (Bothell, WA)
- …processes for recombinant proteins and biological macromolecules for early- and late-phase clinical trials. The responsibilities of this position include but are not ... of relevant experience TECHNICAL SKILLS REQUIREMENTS: Relevant experience in laboratory or manufacturing setting, preferably with preparative or analytical… more
