• Research Scientist - ICH Guidelines

    ThermoFisher Scientific (Boston, MA)
    …with analytical support for late-stage or commercial biological products and cGMP manufacturing + Experience with critical reagent management + Experience of ... using JMP or similar statistical tools is a plus + Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency **Working Environment:** Below is listed the working… more
    ThermoFisher Scientific (08/29/25)
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  • Senior Staff Engineer, Modeling

    Takeda Pharmaceuticals (Boston, MA)
    …process development activities. + Understanding of current Good Manufacturing Practices ( cGMP ) **Knowledge and Skills:** + Analytical and Problem Solving Skills - ... Able to troubleshoot critical issues or problems, and determine causes and possible solutions. + Teamwork -- Ability to work well in highly cross functional team environment and across global line functions. + Communication Skills -Able to expresses one's self… more
    Takeda Pharmaceuticals (08/29/25)
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  • Staff Design & Reliability Assurance Quality…

    Integra LifeSciences (Mansfield, MA)
    …Directive), IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP . * Strong analytical skills and a working knowledge of problem-solving methodologies ... * Working knowledge of DFSS techniques * 8 years of experience in a Quality Assurance role for medical device or pharmaceutical product development * Fluent in French and English * Knowledge of industry best practices and advances in Risk Management practices,… more
    Integra LifeSciences (08/27/25)
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  • Talent Pipeline - Laboratory Support Services…

    Cambrex High Point (Agawam, MA)
    …proper operation. + Ability to clean rooms, equipment, & tools for use in cGMP environment. + Ability to maintain positive attendance record. + Positive attitude & ... the ability to work in a team environment. Education, Experience & Licensing Requirements + Associate's Degree or certificate in related science discipline, or + High School Diploma with 1+ years of experience in regulated environment Cambrex is an Equal… more
    Cambrex High Point (08/19/25)
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  • Staff Engineer, R&D

    Jabil (Clinton, MA)
    …- Must have working knowledge of FDA requirements, including 21CFR820, ISO13485, ISO14971, CGMP and other standards as they relate to the design, manufacture, and ... risk assessment of medical devices - Highly proficient in SolidWorks, tolerance stack-ups, geometric dimensioning and tolerancing - Device development experience involving common medical device polymers and related processes - Competent using statistical… more
    Jabil (08/16/25)
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  • Scientist / Sr. Scientist, Analytical Development

    Cambrex High Point (Waltham, MA)
    …scoping, technical oversight, and data review. + Ensure all analytical work meets cGMP standards and company quality system requirements. + Maintain a strong sense ... of urgency to meet project timelines and client deliverables without compromising quality. + Communicate directly with clients to provide project updates, interpret results, address technical inquiries, and present analytical strategies and timelines. +… more
    Cambrex High Point (08/14/25)
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  • Director of Quality

    Catalent Pharma Solutions (Chelsea, MA)
    …dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions in ... Chelsea, MA is hiring a Director of Quality who will provides leadership and daily management of the Catalent Boston Quality Department - Quality Assurance and Laboratory (Analytical Development/Quality Control). The responsibility of the role is to provide… more
    Catalent Pharma Solutions (08/12/25)
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  • Project Manager, Life Sciences

    Stantec (Devens, MA)
    …of 5-10 years' experience in a related field. - Experience in cGxP and/or cGMP is required. - Experience as an Owner's Representative in Project Management on ... biopharmaceutical/ life sciences projects is an asset - Experience managing capital projects previously is required. - Experience with manufacturing processes or process engineering is an asset. - Experience with scheduling software is a plus. This description… more
    Stantec (08/07/25)
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  • Quality Control Technician II, Analytical

    Integra LifeSciences (Braintree, MA)
    …in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other cGMP regulated product preferred environment. + Familiarity with application of ... FDA and/or ISO quality standards in a government regulated industry. Quality Certification (eg, CQE, CQA, Six Sigma) preferred. + Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets,… more
    Integra LifeSciences (07/31/25)
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  • Laboratory Equipment IT Engineer, Regeneron Cell…

    Regeneron Pharmaceuticals (Cambridge, MA)
    …of data as needed + Creating and maintaining configuration specifications for cGMP software for process control, monitoring and testing + Ensuring systems remain ... in compliant state including process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments + Supporting system integration with existing systems (ex.… more
    Regeneron Pharmaceuticals (07/26/25)
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