- Merck & Co. (Durham, NC)
- …operations on the production floor, coordination across processing suites, real-time batch record review, execution of aseptic processing requirements as needed, ... to :- Executes operational review and comment resolution of batch records to include binder assembly.Maintains gown qualification.Maintains qualification within… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing to ensure sterility of the product/process is not compromised.Support batch review & material release in SAP for In-house reagents.Support Floor ... prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, cross-functional environment to… more
- Aequor (Davie, FL)
- …Manufacturing Practices (cGMP's), and Standard Operating Procedures (SOP's) and Batch Record instructions. Responsible for performing additional related duties as ... to prepare various types of complex high quality technical documentation ( Batch Records (BR), Change Controls (CC), protocols, summary reports, technical… more
- Tris Pharma (Monmouth Junction, NJ)
- …Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications. She/he operates and maintains various pharmaceutical packaging ... of pharmaceutical products according to SOPs, cGMPs, FDA standards and batch record specifications Performs the day-to-day activities of the packaging process… more
- Twist BioScience (South San Francisco, CA)
- …organized, have the ability to follow established SOPs and complete manufacturing batch records to contribute to the daily production schedule. The ideal candidate ... and/or various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule. They will… more
- Merck & Co. (Rahway, NJ)
- …controlExperience with state-of-the-art cell culture processes including intensified inoculum/fed- batch and perfusion process development.Background in data science ... Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.Experience with mathematical modeling, theoretical… more
- Merck & Co. (Rahway, NJ)
- …independently perform or coordinate routine and specialized audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities ... clinical supplies.- Duties include compliance oversite of program-related activities, batch record review and approval, deviation and/or out-of-specification approval,… more
- Aequor (Tampa, FL)
- …wrapping containers. 1-3 Years Experience Summary Execute assembly instructions per Batch Record requirements for Packaging and Labeling processes in compliance with ... the corresponding Room Sanitizations per Departments procedures. Key Accountabilities Follow batch record instructions in the execution of manual process for Primary… more
- Aequor (Hicksville, OH)
- …May assist in the weighing/mixing of sanitizing agents. Completes required batch documentation records. Assembles and disassembles pumps, mills, kettles, etc. ... 70 in horizontal meridian in each eye.Key Performance Indicators Manufacture according to Batch Right the First Time (BRFT) by supporting reduction in rejection of… more
- Merck & Co. (Rahway, NJ)
- …include e quipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge ... capture, and troubleshooting equipment with the aim of advancing process development, aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of… more
- Merck & Co. (Boston, MA)
- …on adoption metrics and business outcomes (reduced cycle time, fewer deviations, improved batch yield). - - - Qualifications: - Bachelor's degree in Life Sciences, ... Biomedical Engineering, Chemical Engineering, Computer Science, or a rel ated field; advanced degree preferred. - 5+ years of experience in technical product management, particularly within the biopharma or healthcare sectors. - Demonstrated understanding of… more
- Aequor (Davie, FL)
- …with data engineers/ data scientists to integrate sensor data and batch records into centralized analytics platforms. Power Platform Developmento Build and ... deploy low-code applications using Power Apps, Power Automate, and Power BI to digitize workflows and enhance productivity.o Use Copilot and Power Fx to simplify app creation and automate repetitive tasks. Validation & Complianceo Ensure systems meet GxP, FDA,… more
- Merck & Co. (Rahway, NJ)
- …GMP Compliance, Inventory Control Management, Logistics Coordination, Master Batch Records, Materials Procurement, Pharmacy Inventory Management, Pharmacy Management ... Software, Production Planning, Site Initiation, Social Collaboration {+ 4 more}-Preferred Skills:Job Posting End Date:09/29/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process of existing SOPs in time to support Manufacturing Strategy.Ensure Master Batch Record changes are made in time to support Manufacturing Strategy.Ensure ... proper training is prescribed as per the document changes made.Liaison with Operations, Technical Operations and QA to ensure alignment of changes.Continuous improvement of all GMP documents to ensure they are streamlined and robust, easy to use and intuitive;… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manager. Higher-level approvals are required for those related to significant batch impact, or elevated resource allocation as directed by engineering ... manager.RequirementsBachelor's Degree - Preferably in Engineering or Life Sciences.0-2 years of experience in Facility, Engineering, or Operations (internship or co-op experience in a GMP setting preferred).Proficiency of Microsoft OfficeExperience with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …techniques.Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, ... concise, format according to Good Documentation Practices (GDP).Perform tasks on time in a manner consistent with quality systems and cGMP requirements.Work in a team based, cross-functional environment to complete production tasks required by shift… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …creation of master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO ... personnel.Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.Coordinates authorized destruction of investigational products with approved vendors and obtains required… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of equipment, and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, ... concise format.Perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse, Engineering, and Quality, and work as part of a cross-functional team to complete… more
- Merck & Co. (Rahway, NJ)
- …viral clearance, precipitation, crystallization, and continuous processing for batch and intensified/continuous bioprocesses.- The role will also include ... strategic Applicants should have effective organizational and multi-tasking skills and strong communication skills both verbal and presentation of data is required. A track record of leveraging data science and digital tools for delivering impactful solutions… more
- AUROBINDO (Dayton, OH)
- …Must have experience in development to large scale submission batch manufacture. ResponsibilitiesSenior Scientist with previous industrial experience developing and ... filing generic drug dosage forms (orals/liquids)Ability to develop the product using FBD, Compression and EncapsulationAbility to perform extensive Literature Search on assigned Projects.Thorough understanding of the ANDA (and preferably NDA) filing process in… more
