- Insmed Incorporated (San Diego, CA)
- …material specifications, protocols and author development reports.Demonstrated experience with process validation and scale-down models for biopharmaceutical ... Medium Workplaces™ lists.OverviewWe are seeking a highly motivated expert in purification process development of viral vector gene therapy products. In this role you… more
- Repligen (Rancho Dominguez, CA)
- …bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation , and facility upgrades. Conceives, plans, and executes ... is highly desirable. Hands-on experience with: Tangential Flow Filtration (TFF) Process validation and equipment qualification Tech transfer between sites… more
- Merck & Co. (Rahway, NJ)
- …of product design and development, manufacturing process development, qualification, validation , and design control and risk management techniques to ... requirement management, design verification, automation/ process development, design validation , human factors evaluations and control strategy.Deep and… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and ... guidance, performs analytical method validations and release/stability raw materials, in process (IP), finished products (FP) and stability (ST) samples for pilot… more
- Twist BioScience (South San Francisco, CA)
- …custom software and CSV.Experience with data analytics tools and methodologies for process monitoring and quality control in biotech, including building custom ... Sr . Director, Manufacturing Execution System (MES) (Hybrid in...requirements gathering, system design, coding standards, development, rigorous testing, validation , deployment, and post-go-live support for new and existing… more
- Merck & Co. (Rahway, NJ)
- …on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will ... experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation , filing and supply… more
- Merck & Co. (Rahway, NJ)
- …with device design, requirement management, FMEA, design verification, design validation , statistical sampling, and control strategyExperience with regulatory ... DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls (Associate Director Equivalent) Our company's Device Development & Technology… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …combined experience in commercial scale cGMP manufacturing, operations management, tech transfer, process and equipment validation or quality management; with a ... schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management… more
- Merck & Co. (Rahway, NJ)
- …to capture patient and process risk and identify appropriate in- process controls to ensure robust and efficient throughput.Develop characterization plans ... Job DescriptionAs a Senior Engineer in Device Design and Process...equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.Understanding of autoinjector/parenteral/pre-filled… more
- US Bank (Atlanta, GA)
- …implementation process , as well as model usage and performance. The validation process also identifies corrective actions to ensure timely remediation of ... at the Bank. The overall MRM program is designed to provide governance and control to manage financial models and associated risks that may impact the company,… more
- ACROBiosystems Inc. (New York, NY)
- …support drug development and clinical applications from target discovery and validation , candidate drug screening and optimization, CMC development, preclinical and ... to excellence in providing quality products and services and accelerating the process of therapeutic development. Our mission is to accelerate the process… more
- Merck & Co. (Rahway, NJ)
- …techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related ... Immunoassays, Immunochemistry, Innovation, Laboratory Informatics, Liquid Chromatography (LC), Management Process , Matrix Management, Mentoring Staff, Method Validation … more
- Actalent (Elwood, KS)
- …environments. Expertise in validation testing and protocols. Knowledge in process validation and equipment validation . Excellent technical writing ... utilities, and processes. This position requires consulting with site technical services for process and cleaning validation , while reporting to the Director of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external network for primary intelligence gathering and cross- validation . Oversee development of presentations with clear storylines to communicate ... key conclusions and recommendations to Sr . Leadership. Modernize insight sharing to ensure NNI continues...are well aligned and integrated into North American planning process , including any associated work streams. Ensure self and… more
- Aequor (Thousand Oaks, CA)
- …Filling operations Experience with various quality systems including change control , deviations, corrective and preventative actions, and/or validation ... that enable the B20 plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of… more
- Tesla Motors (Austin, TX)
- …process measurement and control Proven understanding of BOMs, manufacturability, process design, process validation , assembly methods, design reviews, ... experience in a high volume automated manufacturing environment Experience with ergonomic process design, part variation control , and human factors effects on… more
- PharmaLex (Vega Baja, PR)
- …studies, and manufacturing documentation review and approval Develops and authors change controls for cleaning process or equipment changes Maintain an ... looking for experienced or entry-level engineering resources to provide Cleaning Validation services in Juncos PR. Essential Duties and Responsibilities: Development… more
- Ascential Technologies (Andover, MN)
- …capacity analyses, value stream mapping, SMED among others) Robust understanding of process validation concepts and practices including, IQ, DOE, OQ, PQ ... efforts by accomplishing related results as needed Develop statistical methods of quality control . Apply FMEA process to evaluate failure data, if necessary,… more
- Eli Lilly and Company (Lebanon, IN)
- …for tech transfer of products across sites within Eli Lilly, including process validation and commercialization of manufacturing processes for active ... new requests for manufacturing or product changes for project impact. Manages change control process for the project. Drives development of draft operational… more
- TD Bank Group (Mount Laurel, NJ)
- …and performance Represent MRM in regulatory exams and internal audits Present validation findings to key stakeholders and senior management The candidate ... role. Line of Business: Risk Management Job Description: The Senior Manager, Quantitative Analytics oversees and lead a team...strategy and decisions. This role is to lead the validation of Pre-Provision Net Revenue (PPNR) models used in… more