- Genmab (Plainsboro, NJ)
- …futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment ... pace never seen before. Join Genmab as an Associate Director, Solution Architecture and Engineering , R&D Digital Products as part of our IT & Digital Team and become… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …into the site.This site operates 24/7, and you may be required to provide engineering support to Plant operations 24/7 as needed (overall facilities, utilities, ... overall compliance requirements for the Utilities areas, including SOPs, change control, quality investigations and CAPAs. Support the Production Operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis position will be responsible for facilities engineering support , design, and implementation for mechanical systems and ... equipment, and work order management for cGMP Clinical and Commercial Cell Therapy Manufacturing....individual will partner with various Technical Operation functions in support of personalized cell therapy production through safe and… more
- Merck & Co. (Rahway, NJ)
- …and interface with site and global functions such as infrastructure, engineering , system security, risk management , etc.Education Requirement:-Bachelor's degree ... Job DescriptionOur RaDS IT Research Infrastructure Product Line (RIPL) engineering team is seeking a Senior Specialist - Research...Rahway, NJ or West Point, PA and will provide support services to other sites. Travel is expected to… more
- Merck & Co. (Rahway, NJ)
- … management , budgeting and profit planning, communications, competency building, talent management , change management , and business operations to fulfill ... the establishment of execution plans and priorities.Lead and organize overall change management networks for the department.Design and execute organization-wide… more
- Merck & Co. (Rahway, NJ)
- …processes execution throughout Global Regulatory Affairs and Clinical Safety through change management .-Develop, implement and report process objectives and key ... process management organization capabilities (eg, lean six sigma, change management , executive-level facilitation, project management , negotiations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … support teams for their domain area. This includes managing service contracts, change management , and SLA management . The GSM partners with vendors, ... day-to-day operation of the lifecycle of Incident, Problem, and Change Management . Communicate and interface with matrix...for systems and services, measure and report the results. Support IT Senior Management by maintaining high… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Investigations (QI's). He/she supports CAPAs (Corrective and Preventive Actions) and CCs ( Change Controls) within quality management systems. You will also write ... Reliability Engineer will be responsible for ensuring equipment/systems required to support an expanding Cell Therapy facility is appropriately purchased, qualified,… more
- Novo Nordisk Inc. (Durham, NC)
- …a Quality Mindset that focuses on risk management & mitigation Implement effective Change Management Support Corporate, OFP, local IT & local stakeholder ... People Focus, Equipment Focus & Standards "Gatekeeper". Relationships Manager, Technical Support - OFP Essential Functions Work primarily with production (shop… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports on test performance, including success rates, failures, run, and delay timesChange Management : Participate in change management processes to ensure ... to work in a fast-paced GMP environment.Key Responsibilities Testing Scheduling Management : Configure, monitor, and maintain job scheduling systems (eg Smart QC,… more
- Merck & Co. (Rahway, NJ)
- …will ensure that the portfolio overall and each product has robust lifecycle management plans, appropriate and rigorous technical support processes to support ... will lead a department of up to 15-20 personnel overseeing technical support and product stewardship for our company's medical device and combination products… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in Business Transformation methodologies preferred- Certification in Organizational Change Management methodology preferred- PMP Certification preferred ... applications to meet business needs using a standard methodology. Oversee applications support groups' system validation and change control process. Collaborate… more
- Merck & Co. (Rahway, NJ)
- …to support facility operations, process development activities, compliance investigations/ change management , and authoring of GMP documentation. The position ... process development and scale-up Experience supporting compliance investigations and change management . Experience working with Quality systems. Experience… more
- Merck & Co. (Rahway, NJ)
- …to support facility operations, process development activities, compliance investigations/ change management , authoring of GMP documentation, and lead other ... drug substance and/or biologics- Experience supporting compliance investigations and change management . Experience working with Quality systems. Experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversee production metrics. This individual will support manufacturing investigations, support and manage change controls, and maintain permanent inspection ... responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.Key… more
- Aequor (Waltham, MA)
- …(DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission to NDA approval. Our ... art manufacturing processes.About the job:GMU CMC Operation role will provides holistic support into the operational needs of the CMC organization to simplify… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality, HSE, Supply Chain, Warehouse, Training, QC, EM, Operations Technical Support , Facilities and Engineering , MS&T/FinanceRequirementsHigh school diploma or ... and facilities managementComputerized maintenance management systems (CMMS)Quality Management knowledge, including Change control, Deviation, and CAPA's.EHS… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based in Raritan, NJ. Role OverviewThis position will be responsible for providing support to implement and maintain computerized systems in the cGMP Clinical and ... will be responsible in handling day-to-day activities inclusive of project execution and management , vendor management , data life cycle management , Quality… more
- Novo Nordisk Inc. (Boulder, CO)
- …of API Manufacturing. This position interacts with Chemical Development, AD/QC, Engineering , Facilities, Program Management and QA. Essential Functions ... 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works...for oligonucleotide innovation and manufacturing. Together, we are driving change . Are you ready to make a difference? The… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support to manufacturing equipment projects, cost-improvement initiatives, asset management , reliability, and business operations. Support facility project ... or 3rd shift) as part of the Facilities & Engineering team based in Raritan, NJ. Role OverviewThis position...NJ. Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and… more
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