- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director, Global Process Validation as part of the Technical Operations team based ... global MSAT organization. This individual will be responsible for global process validation activities in support of the commercial Carvykti program both within… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as part of the Technical Operations team based in Raritan, NJ. Role OverviewThe Process Validation Technician will support the validation department in ... establishing a robust and sustainable Aseptic Process Validation program through the life cycle of the program.Key Responsibilities Support validation … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …performance indicators and participates in SDLC Lessons Learned sessions to evaluate validation process improvements and efficiencies and measure key success ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Aequor (Thousand Oaks, CA)
- …in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate ... instruments and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol… more
- Merck & Co. (Rahway, NJ)
- …in design controls, risk analysis, control strategies, design verification testing, and process validation , with a strong understanding of quality management ... inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here...you need an accommodation during the application or hiring process . We are an Equal Opportunity Employer, committed to… more
- Merck & Co. (Rahway, NJ)
- …to apply his/her knowledge of product design and development, manufacturing process development, qualification and validation , design controls and device ... position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set… more
- Insmed Incorporated (San Diego, CA)
- …well as drug product.Experience leading and/or interacting with GMP manufacturing, process validation , and tech transfer teams.Domestic and/or International ... Supporting our external manufacturing partners, you will be the process and data expert and will work to further...data expert and will work to further improve the process of manufacturing AAV based therapies. Working closely with… more
- Insmed Incorporated (San Diego, CA)
- …specifications, GMP protocols, and author development reports.Demonstrate experience with process validation and scale-down models for biopharmaceutical ... Medium Workplaces™ lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you… more
- Merck & Co. (Durham, NC)
- …in production. Performs sampling/in- process testing supporting the manufacturing and validation process for current process . Provides timely delivery ... is in direct support of our Sterile Supply manufacturing process for Bulk Drug Substance. Focused areas of responsibility...inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here… more
- Merck & Co. (Durham, NC)
- …used in production. Performs sampling/in- process testing supporting the manufacturing and validation process for current process . Provides timely ... inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here...you need an accommodation during the application or hiring process . We are an Equal Opportunity Employer, committed to… more
- Merck & Co. (Durham, NC)
- …notifying appropriate personnel Conducts sampling/in- process testing supporting the manufacturing and validation process for current process as well as ... and collaboration skills responsible for leads peers in supporting the manufacturing process . Individual will possess the ability to lead a team, train others… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …years of combined experience in cGMP manufacturing, operations management, tech transfer, process and equipment validation and quality management, with a ... preference for cell therapy experienceMinimum of 5 years of experience in a leadership role in Biologics and/or cell therapy operationsDemonstrated ability to build effective and efficient teams and drive change within an organizationExperience in a growth… more
- Merck & Co. (Durham, NC)
- …independentlyPerforms sampling/in- process testing supporting the manufacturing and validation process for current processProvides timely delivery of ... people.This position is in direct support of our Downstream Purification manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but… more
- Merck & Co. (Durham, NC)
- …used in production. - Performs sampling/in- process testing supporting the manufacturing and validation process for current process . - Provides timely ... - This position is in direct support of our Downstream Purification manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …user representative for contractor services including design, fabrication, installation and validation Point person for process improvement activities, including ... of subordinates with direct/indirect referral: None Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needs using a standard methodology. Oversee applications support groups' system validation and change control process . Develop information system ... project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications solutions to meet business needs.Assemble… more
- Aequor (Bothell, WA)
- …This individual contributor has good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation comply with ... POSITION RESPONSIBILITIES: Support Project Lead for method transfer and/or validation internally and externally for assigned program(s). Author or review… more
- Merck & Co. (Rahway, NJ)
- …Stage Analytical Program LeadAbout the roleYou will join our Large Molecule Analytical Validation team to serve as an Analytical Program- Lead. The lead must take ... teams within Biologics and Vaccines AR&D, Global Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory, Quality, and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … improvements/cost reduction program into manufacturing Perform area equipment and process validations in accordance with validation procedures Perform in- ... of routine documentation associated with the manufacture of product Support in- process activities and product development when instructed by supervisor Incorporate… more
- Merck & Co. (Lower Gwynedd, PA)
- …all hands-on laboratory aspects of bioanalytical assay development, qualification/ validation , technology transfer, and/or troubleshooting. The candidate will ... track record for developing assays capable to meet regulatory expectations for validation and line of sight for life-cycle maintenance. The candidate should be… more
