- Merck & Co. (Rahway, NJ)
- …This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. Ultimately, this ... in equipment setups, raw material sampling and subdivisions, solution preparations, batch processing planning and execution at a pilot scale, process knowledge… more
- Eisai, Inc (Raleigh, NC)
- …teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing batch records for completeness, accuracy, and compliance with procedures ... in accordance with internal standards.Support approval and issuance of Master Batch Records (MBRs)Assist with entering events, change controls, and complaints into… more
- Aequor (Hicksville, OH)
- …lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring all ... Instructions tare weights for each packaging component number. Reviews batch paperwork for accuracy and issues to the ...batch paperwork for accuracy and issues to the batch records clerk. Checks and prepares paperwork for upcoming… more
- Twist BioScience (South San Francisco, CA)
- …existing MES functionalities, identify opportunities for process automation, electronic batch record optimization, and advanced data utilization. Ensure robust ... OQ, PQ protocols and documentation, specifically tailored for custom software.Electronic Batch Record (EBR) Management: Lead the design, development, and continuous… more
- Merck & Co. (Rahway, NJ)
- …semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert, assist with ... team with authoring relevant SOPs and specifications to enable clinical batch manufacture.Interface with key stakeholders within the design team, molding team,… 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
- Aequor (Houston, TX)
- …and demonstrates ability to read and comprehend GMP documents (ie SOPs, logs, Batch Records) o Problem solving in a cross-functional setting, and participation and ... and demonstrates ability to read and comprehend GMP documents (ie SOPs, logs, Batch Records) Computer Skills Proficient in the use of spreadsheets, databases, and… more
- AUROBINDO (Durham, NC)
- …packaging material as per SOP and according to Packaging Batch Record.Write and revised applicable standard operating procedures(SOPs).Prepare shipping documents ... as required.To perform all entries in ERP system related to the department.To write the deviations and CAPA for the departmental activities.Perform any and all additional tasks relating to the ware house department as requested.Follow company policies, cGMP's,… more
- Merck & Co. (Rahway, NJ)
- …and subject matter expertise in cell-culture process development for biologics, fed- batch cell culture, bioreactor scale-up and scale-down, as well as recent ... advances, and challenges in the fieldExpertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process developmentTrack record of accomplishments in upstream bioprocessing with a… more
- Merck & Co. (Durham, NC)
- …Information TechnologyPreferred Experience and Skills:Experience in-PLCs, SCADA, DCSs, MES, Batch Operations (S88/S95), IT, and OEM.Ability to perform aseptic ... gowning during the execution of job dutiesStrong leadership, interpersonal and communication skills (written and oral) are requiredCurrent Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to… 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 ... will be driven and will do what it takes to keep manufacturing on track in a fast paced start-up environment. They will uphold standards as defined by the manufacturing process, work on continuous improvement and have good time management resulting in… more
- Aequor (Thousand Oaks, CA)
- …that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses. Identifying improvement opportunities within the organization ... and taking proactive steps to build consensus to implement those opportunities. Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management… 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
- Merck & Co. (Rahway, NJ)
- …and subject matter expertise in cell-culture process development for biologics, fed- batch cell culture, bioreactors across scales, as well as recent advances, ... and challenges in the fieldExpertise in independently conducting and directing the design, execution, analysis, and documentation of all stages of cell-culture process developmentTrack record of accomplishments in upstream bioprocessing with a history of… more
- Aequor (Thousand Oaks, CA)
- …use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality ... approval of minor deviations . Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance… 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
- Novo Nordisk Inc. (Durham, NC)
- …system interfacing and integration required Experience in Project Management, Batch Reporting, Database Tools, Self-analytic BI (Business Intelligence) Tools, Data ... Modelling Techniques, and Machine Learning required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the… more
- Insmed Incorporated (San Diego, CA)
- …process execution within a Pilot Plant non-GMP manufacturing environment.Review batch records, SOPs, raw material specifications, protocols and author development ... reports.Demonstrated experience with process validation and scale-down models for biopharmaceutical processes, including interpretation of results and reporting that stands up to regulatory inspection.Demonstrated expert knowledge of scale-up principles with… more
- Repligen (Hopkinton, IA)
- …and file records appropriately.Process requests and generates labels and batch records for production.Documentation Archival, on and off-site.Assist and supports ... On-Boarding Training.Assists with employee Overdue TrainingTasks associated with the review of production and quality-specific documentation as assigned for purposes of the release of production assemblies.QualificationsBachelor's degree in Biological Science… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …during Agency Inspections, filing of Submissions, and IRs.Maintain global master batch record and documentation on the platform process description and collaborate ... to the global change control process and global investigations.Maintain global program project portfolio and prioritize and drive projects from inception through regulatory approval to global implementation.Requirements BS required, Ph.D. preferred in… more
