- Merck & Co. (Rahway, NJ)
- …and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work ... and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Repligen (Hopkinton, IA)
- …in Document Control in an ISO 9001 certified Quality Management System or equivalentStrong knowledge of Microsoft Office, including Word and Excel. MS Access ... OverviewWe are seeking a Document Control /QA Associate I to join our growing Quality...actively participate in the Repligen ISO 9001 Quality Management System . This role is responsible for assisting the document… more
- BioAgilytix (Durham, NC)
- …governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes, ... processes to automate data extraction, transformation, and loading from core systems (LabVantage LIMS, ERP) into a centralized data repository.Design and implement… more
- Farrar Corporation (Norwich, KS)
- …centers, (PLC's) programmable logic controllers, control panels, pneumatic and hydraulic systems , and electrical control systems . Primary Duties & ... safety rules, code books, and specifications Demonstrated ability to inspect electrical control systems , equipment, and machines and identify problems Knowledge… more
- Merck & Co. (Durham, NC)
- …technology transfer focusing on either upstream, downstream, and/or culture media/support systems . Off-shift and weekend coverage will be required based on business ... qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates… more
- Merck & Co. (Rahway, NJ)
- …syringes, and complex drug delivery systems .Proven expertise in design controls , risk analysis, control strategies, design verification testing, and process ... products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical… more
- Twist BioScience (South San Francisco, CA)
- …a proven ability to scale accounting operations, and the determination to lead the department through growth and continuous improvement.Position is Hybrid - Tuesday, ... support strategic initiatives by establishing the proper general ledger structure and controls for investments in new products and servicesEnsure proper oversight of… more
- Novo Nordisk Inc. (Durham, NC)
- …in relevant areas Own self development & initiative to understand the site process control systems , data management systems , and differing data sources (PCS, ... systems and associated applications required Proven expertise in system interfacing and integration required Experience in Project Management, Batch Reporting,… more
- Twist BioScience (South San Francisco, CA)
- …culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/ control systems (SCADA, DCS, PLC, HMI) from a software ... DescriptionWe are seeking an experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation,… more
- Aequor (Thousand Oaks, CA)
- …a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI Lead is expected ... Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and preventative… more
- Merck & Co. (Rahway, NJ)
- …Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control System , Inventory Management, Management Process, Multiple ... and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings...assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Summary:The Payments Manager will help lead the strategic direction, operational quality, and innovation of the credit union's payments ... for performance, member experience, and operational efficiency.Risk & ComplianceMaintain strong controls and procedures to comply with all applicable laws and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of IT security strategy and serving as a security advisor to ensure IT systems are implemented and maintained to the highest security standards. Individuals in this ... for performing technical risk and vulnerability assessments at the network, system , and application level. Some responsibilities developing and implementing security… more
- Repligen (Rancho Dominguez, CA)
- …Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing systems . Lead projects in equipment design, tech transfer, process validation, and ... are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at… 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
- Repligen (Clifton Park, NY)
- …the tools and techniques of Lean Manufacturing and incorporate it into the culture. Lead the implementation of the Repligen Performance System (RPS) throughout ... linear motion, cartesian motion (ie, pick & place, measurement, load, and unload). Controls - vision systems , PLC, sensors, pneumatics, hydraulics, electronics,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Merck & Co. (Rahway, NJ)
- …and IT functions, and develop strategic digital roadmaps, and lead delivery of capital project digital programs.Responsibilities include:Planning and allocating ... our Company's manufacturing division.Understanding of the existing IT portfolio of systems and products.- Understanding of the external technology landscape and the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThe purpose of the Senior Director, Forecasting & Business Analytics is to lead the forecasting and financial and analytical support of commercial assets. In ... addition, this role will lead the forecasting process supporting the Business Development team...established Revenue forecasting process, puts into effect governance and controls steps to safeguard the integrity of the process… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
