- Merck & Co. (Durham, NC)
- …bulk active ingredient, finished product, and laboratory testing for the BCG vaccine.The Senior Specialist, Quality Control participates in a team of analysts in ... assay development, assay validation, equipment validation, and GMP laboratory readiness.- The Senior Specialist, Quality Control will be responsible for starting… more
- Merck & Co. (Rahway, NJ)
- …clinical data management concepts; CDISC SDTM and ADaM standards; ensuring process compliance and deliverable quality ; and designing statistical databases with ... programming activities for Early Oncology clinical development projects.Review the quality and reliability of clinical studies using deep scientific knowledge,… more
- Aequor (Thousand Oaks, CA)
- …worker to join our Pivotal Drug Product Technologies Group as Process Development Senior Associate in Thousand Oaks, CA. This group is responsible for late-stage ... (eg, monoclonal antibodies, bispecific T-cell engagers (BiTEs), fusion proteins, etc.). The Senior Associate will work in a highly collaborative team focusing on… more
- Merck & Co. (Durham, NC)
- …maintenance, repair, calibration and troubleshooting of complex automated process equipment.Work compliance systems for maintaining PM program and assessing ... Job DescriptionThe Senior Maintenance Technician is responsible for providing equipment...team culture including significant interaction with Production, Technical Operations, Quality and other support groups. This position will be… more
- Twist BioScience (South San Francisco, CA)
- …production processes, project management, Supply Chain andWarehouse Management, Validation, and Quality Systems . Prior experience supporting other peripheral ... The Sr Master Data Mgmt. Specialist is responsible for...data governance processes for Twist Operations toensure a high quality of data throughout all systems where… more
- Novo Nordisk Inc. (Durham, NC)
- …areas of Systematic Problem Solving, process improvement, & project management Operate within compliance with a Quality Mindset that focuses on risk management & ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...make what matters. The Position Seeking level II or Sr level Application Engineers with Pas-X experience. This position… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …success.Pay and title will be commensurate with experience. Relationships Reports to: Sr . Manager, Human Resources Essential Functions Coaching people managers for ... quality and execution timeliness for HR processes as assigned...and providing appropriate guidance to drive manager consistency and compliance in handling performance management Onboard new managers and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and product stewardship ... continuous improvement activities that ensure the safety, effectiveness, and compliance of the company's products.- The organization will ensure post-market… more
- Merck & Co. (Rahway, NJ)
- …RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research Automation OT Infrastructure. This position will be a ... the Research Automation Operations product (Laboratory and Plant) within RIPL. -As Sr . OT Infrastructure Specialist, you will lead the definition and implementation… more
- Aequor (Thousand Oaks, CA)
- …evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr . Associate will also represent ... the execution of their processes, procedures, and use of quality systems . Duties include purposeful presence on...training, and good documentation practices. Also, ability to make Quality based decisions in order to ensure compliance… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and start-up) of all GMP Utilities as well as closely monitoring the existing systems with respect to quality of final product and efficiency of operation. ... As a Sr Utilities Engineer (Clean Utilities), you will provide...Utilities), you will provide cross-functional support to operations, maintenance, quality and project teams for site GMP utilities. You… more
- Merck & Co. (Lower Gwynedd, PA)
- …Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking a Senior Director to lead the Regulated Robotics & LIMS team within the ... vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. As the AdVAnce facility will not be fully… more
- Aequor (Thousand Oaks, CA)
- Senior Specialist QA Remote any time zone OK...GCO). In this vital role you will support the quality management system team to provide proactive compliance ... Does the thought of building an entirely new digital quality management system, excite you? Do you love to...that support the Digital QMS Maintain knowledge of current systems , tools, standard methodologies, and terminology and ensure adherence… more
- Twist BioScience (South San Francisco, CA)
- Senior Scientist/Scientist, NGS R&DThis role can be filled at the Sr Scientist or Scientist level, depending on experience.The R&D team at Twist is searching for ... NGS kits and Target Enrichment Panel lines, ensuring increased efficiency, quality , and scalability.Innovate and refine commercial kits and components, including… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Senior Controls Engineer will be responsible for installing, modifying, and servicing process control systems throughout the facility as ... of the manufacturing processes as well as providing electrical engineering. The Sr . Controls Engineer will utilize data management skills, PLC (Programmable Logic… more
- Merck & Co. (North Wales, PA)
- …data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality .Strategic thinking - ability to turn ... stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....& Novo Nordisk (eg Investigators and site staff, Health Systems , Contract Research Organizations and Site Management Organizations etc.)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act as an advisor to North America Operations… more
- Merck & Co. (Rahway, NJ)
- …solutions that reduce risk and enable new organizational capabilities.The CTI Senior Specialist is responsible for the daily prioritization and actioning of ... Intelligence (CTI), to include intelligence collection, curation, management, analysis standards, quality control, and dissemination of finished products to a wide… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply ... Operations team.As Senior Clinical Drug Supply Manager you will play a...a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage… more
