- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls (Associate Director Equivalent) Our company's Device Development & Technology ... responsible for leading and implementing medical device and combination product design controls for both new products and inline products from early design concept… more
- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control /QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am EST - ... 4:30 pm EST.The Document Control /QA Associate I will report directly to the QA/QC...Lead and/or Management on daily progressAbility to contribute to project teamsFocus and attention to detail is criticalWorking knowledge… more
- Merck & Co. (Rahway, NJ)
- …and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence ... the established requirements.Represent Device Development & Technology and the project -specific Combination Product Working Groups on cross-functional teams at the… more
- Aequor (Thousand Oaks, CA)
- …at ATO B20. The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 with a ... Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading… more
- Merck & Co. (Rahway, NJ)
- …challenges and influence across the enterprisePreferred Experience and Skills: Project management, including change control and equipment qualificationSAP ... Requests, People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems, Project Management, Regulatory Compliance, Regulatory… more
- Merck & Co. (Durham, NC)
- …safety, quality and process enhancements throughout the supply chain - Project Management Lead and sponsor all Supply Chain Logistics initiatives surrounding ... (SOP) to align to SAP and business processes related to any new project implementations.Site supply chain lead and coordinator for the successful implementation of… more
- Merck & Co. (Rahway, NJ)
- …equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding of autoinjector/parenteral/pre-filled ... to capture patient and process risk and identify appropriate in-process controls to ensure robust and efficient throughput.Develop characterization plans and… more
- Aequor (Thousand Oaks, CA)
- …such as Monte Carlo simulations Familiar with utilizing GitLab for version control , code collaboration, and project management Data analysis expertise and ... and technical documentation skills are a plus, as is knowledge of process controls Understanding business needs and developing Client yet practical solutions to meet… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(PV) oversight. This role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from the affiliate perspective ... Time' mindset to effectively perform quality assessments and deliver quality control on identified areas of focus within external pharmacovigilance (PV) partners… more
- Merck & Co. (Rahway, NJ)
- …will be instrumental in supporting DS commercialization, process characterization, control strategy development, tech transfer to internal and external manufacturing ... all stages of cell culture process commercialization. Risk assessment, control strategies, process comparability reports, Process performance qualification, and/or… more
- Novo Nordisk Inc. (Durham, NC)
- …machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive ... from wide variety of data sources Support manufacturing, business, and project departments with process understanding, analyses, and systematic problem solving… more
- Aequor (Tampa, FL)
- …and finished products. Support QC chemist to provide the method technology transfer and project preparation work, make sure the project runs on time and ... completes CAPA in response to laboratory investigations. Manages change controls effectively. Manages/ supports microbiology projects from production or formulations… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …related projects. He/she will work with Planners, Manufacturing, Facilities, Quality Control , MSAT, and Engineering to support and improve the planning processes ... partner with PAS-X, SAP, OMP and shop floor planning project teams on master data and system adoption Analyze...maintain site capacity data, future state objectives, and schedule control Implement LEAN & flow in the plant, proactively,… more
- Merck & Co. (Rahway, NJ)
- …to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.Conceptualize, plan, and execute ... BPR&D as a upstream bioprocess expert/co-leader in internal and cross-functional project teams.Supervise, coach, and develop talent within the functional area; guide… more
- Twist BioScience (South San Francisco, CA)
- …core teams. Collaborates with team members to develop detailed project plans. Coordinates activities across multiple functional groups including Product ... Management, R&D, tech transfer, manufacturing, and QC/QA.Leads and facilitates project meetings with an efficient and structured approach to ensure successful… more
- Merck & Co. (Rahway, NJ)
- …strategic digital roadmaps, and lead delivery of capital project digital programs.Responsibilities include:Planning and allocating resources for cross-product ... of initiatives to Product Lines and operational teams on project completion.Required Competencies:Proven experience in resource planning, cost estimation, and… more
- Repligen (Rancho Dominguez, CA)
- …a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at our Rancho ... regulations. Develop and maintain engineering documentation including test protocols, change controls , and technical reports. Guide the integration of new products… more
- Merck & Co. (Rahway, NJ)
- …for performance, member experience, and operational efficiency.Risk & ComplianceMaintain strong controls and procedures to comply with all applicable laws and ... management, strategic planning, and regulatory compliance.Strong analytical, negotiation, and project management skills.Exceptional leadership, interpersonal, and communication abilities.Preferred Experience:Experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …initiatives, asset management, reliability, and business operations.Support facility project initiatives as neededMaintain knowledge of and compliance to ... and provide repairs to equipment, instruments, instrumentation systems, electrical systems, controls , motors with voltages up to 600 voltsOperate, monitor, and… more
- Merck & Co. (Durham, NC)
- …opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This ... drug product, including product inspection, warehouse, utilities, and quality control laboratories.The Specialist, Operations will be responsible for providing… more
