- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... for leading cross functional teams on all aspects of technical transfer including analytical transfer , development studies, clinical supplies, manufacturing… more
- Merck & Co. (Rahway, NJ)
- …in the design, development, and optimization of cell culture processes and the transfer of processes to clinical and commercial manufacturing sites. She/He will also ... integrating PAT efforts.Experience with late-stage commercial process development, technology transfer , scale-down model qualification, and process characterization.Knowledge of biologics… more
- Insmed Incorporated (San Diego, CA)
- …They will act as a primary liaison between R&D and Analytical Development for transfer of research bioassays into the CMC space prior to elevation of a drug ... potency bioassay. The Assoc. Principal Scientist will develop, improve, implement, transfer and co-validate cell-based potency assays with a receiving laboratory (QC… more
- AUROBINDO (Dayton, OH)
- …projects from bench-top stage to large scale manufacture of submission batches.Technology Transfer of ANDA Products under Manufacturing of Site Transfer Exhibit ... and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer , leaves of absence, compensation, and… more
- Merck & Co. (Rahway, NJ)
- …experience to develop safe and robust processes through process characterization, tech transfer , validation, filing and supply support. -The incumbent is expected to ... bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities. The scientist will be...to learn and engage in process scale-up and technology transfer , moving from laboratory to pilot plant or factory… more
- Merck & Co. (Rahway, NJ)
- …will be responsible for development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex ... work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program… more
- AUROBINDO (Durham, NC)
- …and small molecules. Expertise in method development, validation, and technology transfer , with strong knowledge of manufacturing, analytical, and quality control ... ones.Generate lab procedures, reports and/or instructions and/or SOPs; Actively transfer procedures/instructions to pilot plant or production, including troubleshooting,… more
- Novo Nordisk Inc. (Boulder, CO)
- …Boulder Pilot Plant Manage in collaboration with Chemical Development and Manufacturing, the transfer and scale up of processes to the manufacturing scale and Pilot ... Plant equipment Support the technology transfer of internal manufacturing processes to the partner CMO's...techniques and equipment is highly desired Experience in the transfer and scale-up of development processes to the manufacturing… more
- Merck & Co. (Rahway, NJ)
- …playing an active role in development of cell culture processes and transfer to clinical and commercial manufacturing sites. She/He will also develop strategies ... bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities.Working knowledge of cell culture media, CHO cell… 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
- Merck & Co. (Rahway, NJ)
- …including process flow diagrams & engineering drawingsProcess development and technology transfer experience including the use of risk assessment and process ... and/or validation is preferredFill/finish process scale-up, Drug Delivery and/or technology transfer experience including the use of gap analysis and risk assessment… more
- Merck & Co. (Rahway, NJ)
- …second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing ... process commercialization.Experience with late-stage commercial process development (CPD), technology transfer (TT), scale-down model qualification (SDMQ) and process characterization… 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
- 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 (Drug Substance, Drug Product, Plant and Clean utilities), product equipment… more
- Merck & Co. (Rahway, NJ)
- …(liquid/ lyophilized/ complex systems).The candidate should have experience with technology transfer to facilitate scale-up of early phase and late phase biologic ... biologics process development and process characterization to enable efficient tech transfer to manufacturing sites.Experience in modeling such as Monte Carlo… more
- Merck & Co. (Rahway, NJ)
- …to develop safe, robust and productive processes, through scale-up, tech transfer , process characterization, validation and filing.- This role involves hands-on ... and crystallization.Demonstrations of successful chemical process scale-up and technology transfer , moving from laboratory to pilot plant or production… more
- Merck & Co. (North Wales, PA)
- …tailored strategies, including content creation, educational programs, and knowledge transfer initiatives, to address those needs.Fostering a Culture of Knowledge ... Sharing: Champion a collaborative environment that encourages employees to contribute to and access the knowledge base. Establish effective dissemination channels, including intranet portals, newsletters, and communities of practice, to enhance knowledge… more
- Aequor (Framingham, MA)
- …May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control. Interpret complex, explicit documentation to ... ensure quality standards and compliance. May provide training to new employees. Work under only very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy. Contribute to the completion of organizational projects and… more
- Merck & Co. (Rahway, NJ)
- …F, foreign tax credits and familiar with financial supply chains and transfer pricing--Able to work in a deadline-driven environmentStrong analytical skills, problem ... solving and project management skillsStrong interpersonal skills, able to work collaboratively in a team environment as well as independently to achieve resultsExtensive experience in US tax planning, with demonstrated expertise in technical tax analysis and… more
- Twist BioScience (South San Francisco, CA)
- …across multiple functional groups including Product Management, R&D, tech transfer , manufacturing, and QC/QA.Leads and facilitates project meetings with an ... efficient and structured approach to ensure successful execution. Generates and disseminates meeting minutes which accurately capture key decisions, open issues and action items. Follows up on status of task and action item execution both within and outside of… more
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