- Exela Pharma Sciences, LLC (Lenoir, NC)
- …( non -viable), surface (RODAC), and swab sampling to support manufacturing and/or qualification activities.Perform aseptic interventions, when necessary, on the ... Aseptic Manufacturing LeadPosition Summary:The Aseptic Manufacturing Lead...position offers a unique opportunity to microbiology professionals a non -traditional (outside the lab) pathway to advance rapidly in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …regulations.Provide Quality Oversight for batch records, change controls, SOPs, non -conformances, risk assessments, and CAPAs associated with manufacturing ... the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team...Quality team based in Raritan, NJ. Role OverviewThe QA Manufacturing Excellence Manager role is an exempt level position… more
- Merck & Co. (Rahway, NJ)
- …GMP clinical supply manufacture of our company's drug product pipeline.- The FLEx Non -Sterile Production Lead will steer this facility within the FLEx network.- They ... will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of formulations in support of oral and… more
- Merck & Co. (Rahway, NJ)
- …configuration for Direct Procurement. Ability to collaborate with other SAP and non -SAP Business Areas, Digital Manufacturing Division, Compliance, our Research ... support to the Pharmaceutical Research and Development (R&D), Supply Chain ( Manufacturing ), Marketing (Human Health) organizations as well as Enabling Functions. The… more
- Merck & Co. (Rahway, NJ)
- …for development of new technologies/capabilities, execution of capital and non -capital improvement projects, and interfacing with the automation system assets ... molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The Associate… more
- Merck & Co. (Millsboro, DE)
- …processes including but not limited to: Sterile Services, Viral Bulk Manufacturing , Blend/Fill, Packaging, and Warehousing.The hiring team will evaluate your skills ... provide you the necessary training the Technician will need to follow Good Manufacturing Practices and Standard Operating Procedures and adhere to all safety and… more
- Novo Nordisk Inc. (Durham, NC)
- …of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable ... agendas in conjunction with other departmental leaders Process Group Responsibilities ( non -Technical) as required representing the Bulk area & contributing globally… more
- American Honda Motor Co Inc (Marysville, OH)
- …fully informed decisions.This position will participate in Honda Development & Manufacturing of America, LLC's (HDMA) Engineering Development Program (EDP), which ... engineers to gain experience on the various facets that create HDMA's manufacturing and business operations. Successful graduates of HDMA's EDP will return to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …include material receipt, incoming inspection and release of materials required for manufacturing and release of patient material/final product of CAR-T at Raritan, ... NJ Legend manufacturing site.Key Responsibilities Be part of the quality team...in support of Final Product Shipments.Generates inspection reports and non -conformances for failures as required. Scanning, filing and archival… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sampling, including viable/ non -viable air and surface sampling, related to the manufacturing of LVV used for autologous CAR-T products for clinical trials and ... of multiple myeloma.Legend Biotech is seeking a QC Microbiology Specialist, Lentivirus CAR-T Manufacturing as part of the Quality team based in Raritan, NJ. The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Supervise manufacturing and manufacturing support activities for ... site personnel to provide guidance and determine immediate path forward for manufacturing issues.Real time review of all documentation, and reporting, in support of… more
- Merck & Co. (Rahway, NJ)
- …Sterile and Specialty Products (SSP) group is responsible for developing non -oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and ... our team enables the translation of preclinical candidates into non -oral drug products. Our team is looking for a...of early phase and late phase biologic drug product manufacturing processes to GMP production facilitiesThe candidate should have… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non -GxP activities, assuring that these systems are compliant with global regulatory ... issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non -GxP computer systems implementations in partnership with Global DX, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Agreements in order to assure that all external contractors involved in manufacturing and testing of drug products for commercial and investigational purposes, drug ... Management: Responsible to collect and/or evaluate data information from critical manufacturing steps process and authoring Annual Product Review as per internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs ... biological developmental projects with supervision, including working with contract manufacturing organizations CMO. This position develops strategy, prepares content… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …extend to joint technical and CMC committees that report to the Joint Manufacturing Committee in the commercial governance structure. This person will also be ... product. This effort is business critical and part of a multi-site global manufacturing network whose aim is to maintain Legend's competitive advantage in the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …including viable/ non -viable air and surface sampling, related to the manufacturing of autologous CAR-T products for clinical trials and commercial operations in ... team based in Raritan, NJ. Role OverviewThe QC Microbiology Supervisor, CAR-T Manufacturing is an exempt level position with responsibilities for performing routine… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …product. This effort is business critical and part of a multi-site global manufacturing network whose aim is to maintain Legend's competitive advantage in the ... improvements, optimization, capacity expansion, and cost of goods / non -conformance reduction efforts worldwide.Key Responsibilities Represent MSAT at joint… more
- Merck & Co. (Rahway, NJ)
- …proteins as well as the biopharmaceutic support for the oral and non -oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development ... develop a team whose roles include design and development of formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …written regulations, policies, procedures, and global procedures.Strive to reduce non -conformances in supported areas by proactively driving compliance.Perform tasks ... preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical… more
