• Staff Scientist

    ThermoFisher Scientific (Bedford, MA)
    …in a team, share data, and collaborate to resolve issues. + Familiarity with cGMP and ISO 13485 requirements, including CAPA and Risk Assessments. + Experience with ... Lean/Process Excellence/Six Sigma methodologies. + Strong project management skills. + Understanding of process validation. **Additional Proficiencies:** + Adaptability to a dynamic environment while maintaining a focus on quality. + Good understanding of… more
    ThermoFisher Scientific (09/25/25)
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  • Instrumentation/Calibration Technician

    Mentor Technical Group (Boston, MA)
    …Conductivity + Dimension and Electrical + Knowledge in cGMP + Associate degree in Instrumentation Engineering Qualifications Requirements/Knowledge/Education/Skills: ... + AD, Instrumentation Technology, and or Electronics. + AD, Tecnologia de Instrumentacion y / o Electronica. Physical Requirements and Working Environment: + While performing the duties of this job, the employee is regularly required to use hands to finger,… more
    Mentor Technical Group (09/25/25)
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  • Director, Pharmaceutical Sciences Program…

    Takeda Pharmaceuticals (Boston, MA)
    …Toxicology. + Extensive knowledge of current Good Manufacturing Practices ( cGMP ), ICH Guidelines, other pertinent national regulations, compendial requirements and ... communicating with regulatory agencies. + Must have experience in global regulatory submission requirements and processes. **Program Leadership Skills/Competencies:** Experience with the application of project leadership knowledge, skills, tools, and… more
    Takeda Pharmaceuticals (09/25/25)
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  • Manufacturing Technician II - 12hr. Rotation Shift…

    ThermoFisher Scientific (Chelmsford, MA)
    …manufacturing experience and knowledge of computer applications is required. + Experience in cGMP Environment, use of Delta V, and/or SAP is desirable. + Proficient ... oral and written communication skills are required to be effective in this role. **Knowledge, Skills, Abilities** + Ability to interpret data, perform basic calculations, and troubleshooting skills. + Ability to stand for 80% of the shift, move ~40 lbs. up one… more
    ThermoFisher Scientific (09/24/25)
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  • Category Manager - Clinical Disposables…

    Fresenius Medical Center (Lexington, MA)
    …materials/sources, E-commerce, freight, and SAP utilization enhancements. + Complies with cGMP , ISO, other regulatory requirements, and internal SOPs. Complies with ... Safety procedures. + Maintains general housekeeping of working area and plant. + Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining… more
    Fresenius Medical Center (09/22/25)
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  • Validation Engineering Co-Op (Jan - Jun)

    AbbVie (Worcester, MA)
    …and execute validation plans, and validation protocols in compliance with cGMP practices + Ensures investigations of validation failures are completed thoroughly ... and documented accurately Qualifications Minimum Qualifications + Currently enrolled in university, pursuing a Bachelor's in engineering or other related field + Must be enrolled in school at the time of the Co-Op + Must be able to commit to a 6-month program… more
    AbbVie (09/20/25)
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  • Global Head, BioAnalytics, CMC Development

    Sanofi Group (Framingham, MA)
    …structure-function relationships of biological molecules. + **GMP Experience:** Knowledge of cGMP and experience with leading a GMP function. Experience in ... transferring analytical methods to commercial QC. Ensure compliance with regulatory standards. + **Drug Development:** Development of products leading to successful regulatory approvals, demonstrating a thorough knowledge of regulatory requirements from… more
    Sanofi Group (09/20/25)
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  • Associate Director, Cell Therapy Robustness…

    Bristol Myers Squibb (Devens, MA)
    …such as Python, R, etc., is a plus. + Expert understanding of cGMP regulations and/or business and documentation processes. + Highly proficient in technical writing ... and technical presentations, contributing to broader external and internal scientific community as appropriate. Experience in generating formal reports and articles for publication and in technical presentation + Proficient in project and portfolio management… more
    Bristol Myers Squibb (09/19/25)
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  • Manufacturing Specialist III

    Curia (Boston, MA)
    …III will ensure timely manufacturing of all liquid and lyophilized parenteral cGMP products using aseptic processing technology to deliver high quality sterile ... products to the pharmaceutical industry. This role also provides shift support to manager and supervisor. The incumbent will manage daily manufacturing activities including scheduling, documentation, shift transfer meetings and performance reporting, and… more
    Curia (09/18/25)
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  • Quality Technician 1

    Teleflex (Mansfield, MA)
    …experience of working in the medical device industry preferred * Experience with cGMP , FDA regulations, and ISO Quality Systems, strongly desired * Experience in ... Lean/Six Sigma techniques preferred * Six Sigma Green Belt or ASQ Certification desired * Strong analytical & problem-solving experience (DMAIC, 5Ws, Cause-Effect methods preferred) * Previous participation in 5S events & FMEAs preferred * SAP/ERP system… more
    Teleflex (09/16/25)
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