- Merck & Co. (Rahway, NJ)
- …design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and ... including engineering design, engineering analysis and testing, medical device design controls , risk management, test method/ fixture development, design… more
- Merck & Co. (Durham, NC)
- …Innovation, Process Optimization, Professional Integrity, Project Management, Regulatory Inspections, Risk Control Assessment, Root Cause Analysis (RCA), SAP ... edit technical documents to support regulatory filings including technical reports and risk assessments Author or approve Change Control documentation for… more
- Merck & Co. (Rahway, NJ)
- …Expertise:Utilize extensive experience in design controls , device transfer, control strategies device risk management, and design verification testing ... syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to...syringes, and complex drug delivery systems.Proven expertise in design controls , risk analysis, control strategies,… more
- Merck & Co. (Rahway, NJ)
- …servicing.Establish and track KPIs for performance, member experience, and operational efficiency. Risk & ComplianceMaintain strong controls and procedures to ... Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments… more
- Aequor (Thousand Oaks, CA)
- …and the NPI Lead needs to be able to understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines. ... 100% Onsite supporting ATO Copy of AMAGJP00014054 Standard business hours You've worked hard to become the...Manufacturing" role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems,… more
- Novo Nordisk Inc. (Durham, NC)
- … and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... us make what matters. The Position Serve as a Lead & Subject Matter Expert (SME) to provide technical...from the manager. Responsible for providing data-based insights as business and manufacturing intelligence to an end-consumer business… more
- Merck & Co. (Durham, NC)
- …and associated standard operating procedure (SOP) updates to align to SAP and business processes. -This position will also be responsible for working directly with ... and input to every department on site across a wide range of business activities.- Reporting directly to the Director, Supply Chain Management, the successful… more
- Merck & Co. (Rahway, NJ)
- …as needed. D emonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence ... clinical development teams and the operational/executional arms within the business .-- - - The Program Clinical Supplies Project Manager...and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Merck & Co. (Durham, NC)
- …Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management). Lead Periodic Business and Operations Review Meetings (with ... goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and application level. Some responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports ... insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance & Operations works closely across… more
- Merck & Co. (Rahway, NJ)
- …of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... Internal and External Auditing, Nonconforming Materials, CAPA, Validation, Change Controls , and other product life cycle management activities.Partner with… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... in media/solution development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture predictive modeling (omics (transcriptomics,… more
- Merck & Co. (Rahway, NJ)
- …reports (SORs) to promote fast and efficient closure.As needed, safely perform High Risk Work involving hazardous energy control .Identify and follow through on ... SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relevant skills and techniques in spirit of best-in-class CI leadership Lead development business development analytical due-diligence in alignment with ... by MPS, F&O leadership and in conjunction with current and anticipated business priorities Drives and directs assimilation of market intelligence to ensure that… more
- Merck & Co. (Rahway, NJ)
- …Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems, Electronic Common Technical Document (eCTD), Ethical ... desired results. Reviews and defends stage-gate deliverables for programs including risk assessment and mitigation plans and engages in corporate governance meetings… more
- Merck & Co. (Rahway, NJ)
- …(SORs) to promote fast and efficient closure. - As needed, safely perform High Risk Work involving hazardous energy control . - Identify and follow through on ... PR&D pipeline. Responsibilities: - Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the ... 7 years of relevant experience is required. Demonstrated experience translating business needs to system requirements. Cell/Gene Therapy cGMP manufacturing and… more
