- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that ... regional management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP… more
- Merck & Co. (Rahway, NJ)
- …-scientific leader with expertise in downstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within ... Manufacturing, all within a diverse and inclusive environment. In addition to process development for pipeline biologics, we are focused on innovating and building… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Principal Scientist, Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product ... methods, including principal component analysis, etc.Develop and implement statistical process control methodologies and data anlaysis to ensure the quality… more
- Merck & Co. (Rahway, NJ)
- …for problem-solving and expertise in upstream bioprocessing to join Biologics Process Research & Development (BPR&D) as a Principal Scientist.BPR&D within Research ... Manufacturing while providing a diverse and inclusive environment for all. Beyond process development for pipeline biologics, we innovate and build next generation… more
- Insmed Incorporated (San Diego, CA)
- …Medium Workplaces™ lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you ... for performing experiments ranging from purification development and optimization, process characterization and clinical manufacturing investigation support. As part… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Global Process Steward as part of the Technical Operations team based in Raritan, NJ. ... for all technical scope for the approved Carvykti commercial process and overall program within Legend and with our...and sound cell therapy technical principles and deliver a process platform is robust and consistent. Portfolio management is… more
- Repligen (Rancho Dominguez, CA)
- …manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems, process engineering, and equipment qualification, preferably within GMP or ISO 9001 ... manufacturing systems. Lead projects in equipment design, tech transfer, process validation, and facility upgrades. Conceives, plans, and executes projects… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …The Position This role will be part of our manufacturing downstream purification process support team, dedicated to one of our manufacturing suites. Responsible for ... equipment start-ups from the laboratory through manufacturing scale. The Process Engineer I will work alongside Process ...The Process Engineer I will work alongside Process Associates and Process Scientists to support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready? The Position Responsible for leading process , reporting and compliance related activities for US Talent Acquisition. Responsible ... that the integrity of US regulations and laws are upheld under globalized process changes Manages the overall US compliance to ensure alignment with country rules… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs ... (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi...documentation. In addition, this role will work closely with process owners, subject matter experts (SMEs) and Quality colleagues… more
- Novo Nordisk Inc. (Durham, NC)
- …and help us make what matters. The Position Seeking an experienced to Sr level Process Engineer to support the bulk process tableting line. This role will ... business & regulatory requirements through the following activities: People Focus, Process Focus, Equipment Focus & Standards "Gatekeeper". Relationships Reports to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to: Lead Engineer, Manufacturing Engineering (Supervisor) Essential Functions Leads process and equipment troubleshooting to support deviations, corrective actions ... improvement changes Participate in design and hazard reviews of plant expansions or process changes and serving as the technical point of contact or user… more
- Repligen (Boston, MA)
- …and driven Bioprocessing Sales Specialist to join our team, focusing on Process Analytics Products for downstream Process Analytical Technology (PAT) using ... and Business Development: Drive sales and business development activities for Process Analytics Products within the Northeast Territory. Develop and execute… more
- Merck & Co. (Rahway, NJ)
- …customers.Your leadership will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal ... and external manufacturing sites, process validation, second generation process development and health authority licensure.-You'll lead the charge in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include interactions with NNI vendors involved in the NNI pharmacovigilance process and routine networking through membership in industry association(s). Manage ... serves as Quality Point of Contact for PV Deviation process covering NNI Patient Safety Acts in the role...the role of Deviation Responsible for NNI PV Deviation process , including the drafting of a deviation record with… more
- Merck & Co. (Rahway, NJ)
- …-Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such ... that the process is scalable without compromising stability, safety, efficacy, and...tools, and predictive approaches to inform molecule, formulation, and process selection. In summary, our team enables the translation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …include interactions with NNI vendors involved in the NNI pharmacovigilance process and routine networking through membership in industry association(s). Essential ... resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and global as applicable Proactively identifies and… more
- Merck & Co. (Millsboro, DE)
- …late-shift activities to support the Sterile operations and Logistics Integrated Process Team (IPT) up to and including Central Services, Media Preparation, ... requirementsCoordinate resources between areas of production utilizing the tier process to meet scheduling requirements.Provide training, and coordinate problems… more
- Merck & Co. (Durham, NC)
- …to the manufacturing team and support for the facilityLeading routine process support, projects, and improvement activitiesServing as subject matter expert on ... the process for daily work and projects, understand full process requirements such as safety, compliance, processProviding guidance for daily production support,… more
- Merck & Co. (Rahway, NJ)
- …experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of ... on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a… more
