- Takeda Pharmaceuticals (Lexington, MA)
- …drug substances and products based on the current Good/Laboratory/Manufacturing Practice ( cGMP , cGLP) regulations + Harmonization and standardization of AD but also ... development area for active pharmaceutical ingredients and drug products under cGMP 's + Demonstrates effective project management skills + GMP and compliance… more
- US Tech Solutions (Worcester, MA)
- …The Chemist II will perform laboratory testing within a fast-paced cGMP environment. Experience with **capillary electrophoresis** testing is required. **Key ... in accordance with procedural requirements. + Understands, implements and maintains cGMP with respect to laboratory records, procedures and systems in accordance… more
- Bristol Myers Squibb (Devens, MA)
- …Science or Chem/Bio Engineering + Minimum 0-3 years of industry experience. cGMP and/or Cell Therapy manufacturing experience preferred. This job description is ... intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job… more
- Bristol Myers Squibb (Devens, MA)
- …of in-process and batch release samples of Bulk Drug Substance in a cGMP compliant environment. + Perform routine assays such as UV-VIS Spectrometry, Titer, utility ... testing, personnel and environmental monitoring, Total Organic Carbon testing, and more complex assays including various HPLC methodologies (eg, sialic acid). + Perform activities to support lab operations such as housekeeping, alarm acknowledgement, reagent… more
- Actalent (Milford, MA)
- …delivery systems (process skids). + Two plus years of experience in a cGMP manufacturing environment. Additional Skills & Qualifications + High school diploma or ... equivalent with a college-level Chemistry degree or equivalent work experience. + A biotechnology certificate or college degree is preferred. Work Environment The role is within a GMP-based environment on the 2nd Shift (3:00 PM-11:30 PM, Monday to Friday),… more
- Takeda Pharmaceuticals (Lexington, MA)
- …equipment such as Autoclaves, water baths, pH/Conductivity meters etc. + Knowledge of cGMP 's and applicable agency regulations (such as the FDA, EMEA) to ensure ... inspection readiness of department. + Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure. + In the absence of the supervisor they are the person of authority. + Expected to act on behalf of the… more
- Bristol Myers Squibb (Devens, MA)
- …and work experience may be considered. + 2+ years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing ... is preferred. + Experience with quality management systems preferred. + Experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP) preferred. + Experience with labeling software and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …will report to Manufacturing Supervisor. **How you will contribute:** + Perform cGMP manufacturing operations using SOPs, Batch Records, and Form Preps; troubleshoot ... and escalate process issues, execute production operations, and review documentation in real time to ensure compliance. + Initiate and document minor deviations, create and request GMP documentation and work orders as needed. + Enter data in systems such as… more
- Sanofi Group (Framingham, MA)
- …their families. This is a 12-hour, rotating position in a large-scale cGMP biologics facility. The Sr. Manufacturing Technician will be responsible for performing ... a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also… more
- Bristol Myers Squibb (Devens, MA)
- …and the ability to work independently. + Knowledge of regulatory requirements, primarily cGMP , GxP, including 21CFR part 11, and good documentation practices. + Must ... be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking. + Understanding of quality management systems. + Knowledge of… more
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