- Novo Nordisk Inc. (Durham, NC)
- … Control and LIMS software experience is highly desirable. Relationships Quality Control Senior Manager. Essential Functions Support plans to maintain & ... role will provide support & management of hardware & software on quality control laboratory computer systems. This includes improving reliability of the QC lab… more
- Twist BioScience (South San Francisco, CA)
- …minutes) accordingly.Leads projects and team members through ISO 13485 design control process; creates and maintains a high-quality DHF.Builds high morale and ... direction.Communicates project progress on behalf of core teams to senior management regularly.Proactively identifies any technical/resource issues, concerns or… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our company's Research Laboratories (is committed to ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Merck & Co. (Rahway, NJ)
- …bioprocessing to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our Company Research Laboratories is committed to ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Aequor (Thousand Oaks, CA)
- …determined by the Variation Lead for reportable changes for Global Distribution control . May also translate product launch/variation strategy as determined by the ... to an executable implementation plan for launch/variation changes for Customer Facing SKU control . This role will own the execution of the implementation plan in… more
- Merck & Co. (Rahway, NJ)
- …systemsKnowledge of Quality by Design, Process Characterization and Control Strategy development#BPRD #PRD #EligibleforERPCurrent Employees apply HERE Current ... Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the… more
- Merck & Co. (Rahway, NJ)
- …data stewards responsible for qualification, data analysis, creation, modification and change control for SAC-P (SAP Analytics Cloud Planning). The SAC-P COE Sr. ... Specialist is responsible for supporting Operations and tickets management, ensuring the FP&A calendar activities. Main Responsibilities - Primary responsibilities for this position include, but are not limited to, the following:Manage and oversee SAC planning… 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 ... and maintenance by driving continuous improvement in the automation and control of the manufacturing processes as well as providing electrical engineering.… more
- Merck & Co. (Rahway, NJ)
- …process development, optimization, and scale-up.Experience with developing crystallizations to control and optimize the purity profile of API and intermediates ... by applying mechanistic understanding of impurity rejection.-Experience with technology development to enhance crystallization processes, such development of crystallization models, process intensification technology to improve crystallization robustness,… more
- Novo Nordisk Inc. (Durham, NC)
- …operation of identified local manufacturing applications. Improve reliability of process control systems to meet current & projected customer, business & regulatory ... plans Own self development & initiative to understand the site process control systems Support audits & inspections as SME for specified process applications… more
- Merck & Co. (Rahway, NJ)
- …working within a team supporting regulated applications deployments and change control processes (GxP, SDLC).A genuine interest in learning and development, ... self-motivated, embraces innovative ideas and fosters a collaborative atmosphere in a global organization.Proficiency in written and spoken English.Preferred Experience and Skills: -PMP or equivalent or Scrum Master or Product Owner certificationPrior… more
- Twist BioScience (South San Francisco, CA)
- We're looking for a Senior Bioinformatics Engineer to join our team and help build robust, scalable infrastructure for processing and analyzing next-generation ... architectural decisions for bioinformatics infrastructureEstablish best practices for version control , testing, and deployment of bioinformatics code and pipelinesWhat… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Scientist, CMO MSAT as part of the External Manufacturing team based in ... technical side of the CMO activities: deviation investigation, change control and risk assessment, process improvement, continuous process validation.Support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Quality Control Testing Scheduler as part of the Quality team based in Raritan, NJ. ... QC Testing Scheduler to join our team for Quality Control . The ideal candidate will manage and maintain our...made to the scheduleCollaboration: Work closely with other analysts, senior analysts, supervisors, and management to ensure that testing… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …compliance requirements for the Utilities areas, including SOPs, change control , quality investigations and CAPAs.Support the Production Operations in ensuring ... that utilities equipment is maintained to meet GMP requirements.Support utilities areas in Regulatory / FDA inspections ensuring successful outcomes.Cross functional collaboration with QC Micro, Operations, QA, Reliability, and other Engineering functional… more
- Aequor (Cincinnati, OH)
- …Master's degree or relevant certifications are a plus. Job Description: As a Senior Automation Engineer focused on modernization initiatives, you will play a pivotal ... role in support of designing, developing, and implementing automation solutions that drive our modernization strategy. You will leverage your expertise to optimize existing systems, introduce new technologies, and ensure seamless integration across various… more
- Merck & Co. (South San Francisco, CA)
- …productionizing pipelines, and reproducible research principlesExperience with version control environments, such as GitExperience with high-performance Linux ... cluster and cloud computingExperience working in cross-functional teams and in matrixed environments#EligibleforERP-Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operations, Regulatory, Quality Assurance, Finance, R&D, Project Management and Quality Control departments to complete the technology transfer for customers. This ... processing and testing equipment, along with the necessary skills to design control strategies is needed to interact with customers.Must have led cross functional… more
- Twist BioScience (South San Francisco, CA)
- …Director of Internal Controls and Financial SOX Compliance is a senior -level position responsible, which oversees Twist's Sarbanes-Oxley (SOX) compliance program, ... duties include leading a team of SOX compliance professionals, assessing control risks, driving and tracking SOX remediation initiatives, and communicating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and change management initiatives.Also responsible for expense or headcount control procedures and management reporting capabilities.Develops and maintains a working ... Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies.Partner… more