- Merck & Co. (Rahway, NJ)
- …individual will be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and ... device design , requirement management, FMEA, design verification, design validation, statistical sampling, and control strategyExperience with regulatory… more
- Merck & Co. (Rahway, NJ)
- … design and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support ... , requirement management, design verification, automation/process development, design validation, human factors evaluations and control strategy.Deep… more
- Merck & Co. (Rahway, NJ)
- …requirements for commercializing new products.Technical Expertise:Utilize extensive experience in design controls, device transfer, control strategies device ... in autoinjectors, prefilled syringes, and complex drug delivery systems.Proven expertise in design controls, risk analysis, control strategies, design … more
- Twist BioScience (South San Francisco, CA)
- …timeline, meeting minutes) accordingly.Leads projects and team members through ISO 13485 design control process; creates and maintains a high-quality DHF.Builds ... and driving teams to achieve aggressive goals. Experience with ISO 13485 design control and Quality Management Systems.Superior interpersonal skills and ability… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Principal Scientist, Process Control and Data Analytics will be responsible for leading a team focused on developing and implementing product ... control strategies, statistical analysis, and advanced statistical methods for...such as partial least squares regression, multivariate analysis, and design of experiments.Demonstrated leadership and management experience, including the… more
- Merck & Co. (Rahway, NJ)
- …expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal ... and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on experimentation at the laboratory… more
- Merck & Co. (Rahway, NJ)
- …Process Improvements, Protein Purifications, Regulatory Submissions, Social Collaboration, Statistical Design of Experiments (DOE), Statistical Process Control ... substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in… more
- Twist BioScience (South San Francisco, CA)
- …for our custom MES, including detailed requirements gathering, system design , coding standards, development, rigorous testing, validation, deployment, and ... Process Development, and Regulatory Affairs teams to define MES requirements, design seamless integrations with other enterprise systems (eg, ERP, LIMS, QMS),… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to one of our manufacturing suites. Responsible for assisting with design and implementation of manufacturing processes, instrumentation and equipment start-ups from ... development and implementation of procedural or automation improvement changes Participate in design and hazard reviews of plant expansions or process changes and… more
- BioAgilytix (Durham, NC)
- …governance framework, with hands-on responsibility for data quality, access control , and compliance protocols.Define standards, build quality assurance processes, ... integrity to meet regulatory requirements, including HIPAA, GxP, GDPR, and FIRPA. Design data quality KPIs and implement initial quality checks independently,… more
- Merck & Co. (South San Francisco, CA)
- …implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of ... key collaborator with principal investigators and lab-based colleagues.Primary Responsibilities: - Design , develop, and deploy GenAI models to automate the… more
- Insmed Incorporated (San Diego, CA)
- …of cGMP processes for viral vectors.Take responsibility for the design and execution of purification process development studies.Independently design ... with both internal and external drug substance analytical, quality control , quality assurance, and manufacturing teams.Exercise judgment in selecting methods,… more
- Merck & Co. (Rahway, NJ)
- …is consistently done to reduce instances of recurrence. Identify and design improvement opportunities within the Support Model to reduce compliance risk ... in a highly regulated industry.Experience with business process mapping and system design for workflow management is an asset.Strong aptitude for authoring Technical… more
- Merck & Co. (Rahway, NJ)
- …immensely creative and collaborative team of scientists and engineers to design upstream, cell-culture processes while developing technical strategies related to ... challenges in the fieldExpertise in independently conducting and directing the design , execution, analysis, and documentation of all stages of cell-culture process… more
- Merck & Co. (Rahway, NJ)
- …industry.Required Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a ... knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …guage effort, and deliver robust, right first time EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter ... standardizations and update documentation (eg SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.Act… more
- Twist BioScience (South San Francisco, CA)
- …will combine genomics expertise with strong production engineering skills to design and implement robust, scalable computational pipelines for large-scale NGS data ... role; internal equity; and alignment with market data.Key ResponsibilitiesPipeline Design & ImplementationDevelop and maintain production-grade bioinformatics pipelines for… more
- Novo Nordisk Inc. (Durham, NC)
- …machine learning for anomaly detection and predictive maintenance, advanced control strategies for quality improvements, inventory management using predictive ... and scope with stakeholders Collaborate with cross-functional teams to support the design and building of data pipelines for cleaning, transforming, and combining… more
- Merck & Co. (Durham, NC)
- …with strong scientific and technical skills to contribute to the design , development and manufacturing of sterile products, making accessible our company's ... drug product, including product inspection, warehouse, utilities, and quality control laboratories.The Specialist, Operations will be responsible for providing… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of ... timely reporting, investigation, and resolution of manufacturing deviations, change control , and corrective and preventive actions.6. Oversee and coordinate the… more
