- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading design control ... device design control activities to ensure the delivery of high- quality products and efficient manufacturing processes. The role requires extensive collaboration… more
- Twist BioScience (South San Francisco, CA)
- …Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...our biomanufacturing operations. This critical role will drive efficiency, quality , and robust data integrity within a highly automated… more
- Aequor (Thousand Oaks, CA)
- …cleaning, and reporting including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design , Risk-based Quality Management etc. ... & new ways of working, to assist in the design and implementation of both new technologies, new processes.Job...performance indicators (KPIs) and suggest data-driven improvements Delivering a quality , fit for purpose dataset - plan, build, review… more
- Twist BioScience (South San Francisco, CA)
- …environments.Collaborate with DevOps teams to maintain monitoring, logging, and alerting systems for pipeline reliability and performance. Design and implement ... Senior / Staff Bioinformatics Production Scientist (Hybrid in South...combine genomics expertise with strong production engineering skills to design and implement robust, scalable computational pipelines for large-scale… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThis role is key leadership position within Global QMS and Global Quality Assurance. Overall accountability is develop strategic framework work for GxP ... Function Team Lead development of strategies for the needs assessment, design , planning, delivery, and evaluation of training across the organization. Work… more
- Tris Pharma (Monmouth Junction, NJ)
- …has an immediate opening for a SR . Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, ... guidelines, standards and objectiveOversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …excited about exploring the unknown? Does the idea of driving value through human-centered design pull you in? Are you ready to experiment with us? The Position The ... Senior Manager, Patient Support Data Intelligence is responsible for...analysis, and reporting. Establishes an operational approach along with systems and documented procedures and processes to ensure appropriate… more
- Twist BioScience (South San Francisco, CA)
- …teams and driving teams to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems .Superior interpersonal skills ... will have an opportunity to help shape the team's systems and processes as we continue to scale with...minutes) accordingly.Leads projects and team members through ISO 13485 design control process; creates and maintains a high- quality… more
- Merck & Co. (Rahway, NJ)
- …(eg, cGMP) supporting biopharmaceutical or enzyme manufacturing processes.Knowledge of quality systems , regulatory requirements, and documentation practices in ... Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior Specialist to lead operations supporting enzyme process development and… more
- Merck & Co. (Rahway, NJ)
- …& Development Enabling Technologies Department in Rahway, New Jersey is seeking a Senior Scientist to expand our capabilities to design and engineer proteins ... engineering to improve human health. We leverage computational protein design , advanced automation, high-throughput screening, and machine learning to accelerate… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn, ... in Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication… more
- Repligen (Waltham, MA)
- …vector production. Design and execute experiments to evaluate new filters, systems , and process analytical technologies in the context of mammalian cell ... OverviewWe are seeking a highly skilled and motivated Senior Cell Culture Scientist to join our Advanced...Filtration (TFDF) technologies, as well as testing new filters, systems , and process analytical technologies. Experience with mammalian cell… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity ... IT teams to ensure a strong data and technology foundation Engage senior leaders to drive strategic technology transformations Physical Requirements 10-20% overnight… more
- Formation Bio (New York, NY)
- …who thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and unstructured ... transform unstructured and structured research, biomedical and clinical data into high- quality , actionable assets that power discovery and decision-making across the… more
- Merck & Co. (North Wales, PA)
- …and post marketing support. - The incumbant is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which ... in ensuring that project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves as the statistical… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... make what matters. The Position Seeking an experienced to Sr level Process Engineer to support the bulk process...the bulk process tableting line. This role will improve/develop systems & equipment for the core processes to meet… more
- Cepheid (Miami, FL)
- …Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an ... assay, instrument, software projects and/or system projects.This position reports to the Sr . Director Regulatory Affairs, NPD and is part of the Regulatory Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies, prototype development, and advocate for scalable, compliant architecture and design .Collaborate with global quality , IT, and business leaders to ... in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global … more
- Merck & Co. (Durham, NC)
- …and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director).-This role ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
