- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product, or New ... sub-teams. Accordingly, the candidate is responsible for executing the technology transfer in accordance with the established standard processes to facilitate… more
- Novo Nordisk Inc. (Boulder, CO)
- …lyophilizers, and analytical instrumentation In collaboration with Chemical Development, transfer and scale-up processes from laboratory to pilot plant scale ... to provide suitable root cause investigation analysis Support the technology transfer of manufacturing processes into Phase I/II cGMP Manufacturing Facilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …/ orchestration tools (Tidal Enterprise Schedule or equivalent), enterprise Managed File Transfer tool (Cleo Harmony or equivalent). Must be able to independently ... learning management system.Administration of enterprise job scheduler, Manage File Transfer , Business Intelligence, dashboards, and database environments. Manage service… more
- Aequor (NV)
- …experience *Biotech/ pharma experience required) * Analytical method validation and transfer experience Ideal candidate with a bachelor's degree in Biochemistry, ... will be part of the global method implementation team responsible for method transfer and method validation to Quality Control for pivotal and late stage programs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …documents (SOPs/SOIs), including external data templates, such as External File Transfer Specifications (EFTs), Data Structure Specifications (eDTS) to ensure data ... with Study Data Managers to oversee quality of external data, transfer standards, and issue management. Ensure consistency of standard implementation across… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing network. Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT. Experience in a cross functional commercial team in ... manufacturing sites. Extensive knowledge in cell therapy operations, technology transfer , investigations, capacity/throughput studies, strategic capacity upgrades. Ability to… more
- Novo Nordisk Inc. (Boulder, CO)
- …as oligonucleotide synthesizers, purification systems and analytical instrumentation Support transfer of process improvements internally and to partner CMO's May ... chemistries is highly desired Previous experience with process development and tech. transfer into a manufacturing setting Working Knowledge of Unicorn software for… more
- Merck & Co. (Ames, IA)
- …impact of site inventory destruction.Leading BOM reviews.Encourage supply chain knowledge transfer within the site.On behalf of the Ames site participate in ... Launch, PIT, Transfer meetings as well as regional S&OP meetings.Part of the Site Leadership TeamManage one (1) direct report, who is responsible for buying and… more
- Aequor (Seattle, WA)
- …troubleshooting/root cause analysis when issues arise, during cross-site material transfer process. Identify, maintain, and manage master data needs/gaps to ... ensure a smooth cross-site material transfer process. Serve as a subject matter expert (SME)...as a subject matter expert (SME) for cross-site material transfer operational processes, providing guidance and support as needed.… more
- Merck & Co. (Rahway, NJ)
- …and/or pilot-scale studies to support mechanistic understanding, scale-up, and transfer of processes to manufacturing. Collaboration and effective communication: ... biochemistry, and cell cultureUnderstanding of basic bioreactor principles, mass transfer kineticsUnderstanding of cell & molecular biology Downstream Sound… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role Overview This position will be responsible for managing the technical transfer and clinical/commercial manufacture of cell therapy products in our external ... improvement at the CMO and ensure timely execution of capacity, Tech Transfer and improvement projects. Establish and manage excellent working relationship with… more
- Merck & Co. (Rahway, NJ)
- …selection, vendor interaction/management, factory acceptance testing, technology transfer support, construction support, equipment qualification, facility start-up ... and knowledge transfer . Candidates with significant experience in engineering design (DS, DP, Plant and Clean utilities), product equipment operation, vendor… more
- Merck & Co. (Rahway, NJ)
- …work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program ... link between analytical methodologies for analysis.Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …equipmentMaintain and troubleshoot calibration test systemsPerform calibrations to transfer traceability from Primary Standards to Laboratory Working ... StandardsSupport validation and production engineers in development of metrological specifications for new equipmentDevelop control charts and statistical process controls for calibration standards and resultsAssist in the implementation and maintenance of ISO… more
- Merck & Co. (Rahway, NJ)
- …compositions and processes, GMP manufacturing considerations and scale-up/tech transfer activitiesDemonstrated experience solving program challenges by leveraging a ... breadth of experiences, including oral product development, pharmaceutical operations, commercialization and scientific organic and physical chemistry, analytical chemistry, biopharmaceutics, material science, process development, and/or engineering and… more
- Catalent (CA)
- …function is responsible for identifying, negotiating, and securing new development, tech transfer , and commercial supply business for Rx softgel and late stage oral ... solid products with new customers, and for managing business relationships and growing business with existing customers. This is a field-based remote role responsible for the western region of the United States.Identify, qualify, and pursue Rx softgel and late… more
- Insmed Incorporated (San Diego, CA)
- …as applied to AAV gene therapy products. The scientist will be involved in transfer of method from Analytical Development into QC. The scientist will author and ... RequirementsUpto 10% Domestic and/or International travel required for method transfer activitiesSalary RangeInsmed takes into consideration a combination of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with the latest industry trends, regulations, and best practices Facilitating the transfer of critical knowledge and expertise from experienced personnel to new ... employees, ensuring the preservation and dissemination of institutional knowledge Serve as the CMR Training representative; Liaise with global and HQ counterparts to promote quality and consistency across regions Ensure compliance with SOPs, KPIs, internal… more
- Merck & Co. (Rahway, NJ)
- …for development of analytical methodologies and cross-functionally for successful transfer methods. Plan optimization and documentation to meet program deadlines. ... Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external scientific publications. Experience with matrix management and peer to peer coaching Strong ability to deliver complex objectives under aggressive… more
- Merck & Co. (Rahway, NJ)
- …qualified candidate would have expertise in design, development, optimization and transfer of robust label-free affinity and kinetics methods (ie, using SPR/Biacore, ... Octet) for assessment of biological activity. The candidate will work with technical leaders in the group to establish these types of assays, to write and review technical reports, and to participate in cross-functional teams.The candidate would have good… more
