• Process Development Senior Scientist - Synthetics…

    Amgen (Cambridge, MA)
    …responsible for late phase analytical development, including method development, method validation , method transfer, process and product development support, and GMP ... and stability testing. + Familiarity with USP monographs and chapters, and ICH/ FDA guidance documents related to analytical method transfer and validation ,… more
    Amgen (07/20/25)
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  • Principal Biostatistician FSP - Chemistry,…

    Cytel (Cambridge, MA)
    …support for CMC-related studies, including formulation development, stability studies, process validation , and analytical method validation . + Collaborate with ... + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want our employees to succeed and… more
    Cytel (07/18/25)
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  • Principal Systems Engineer

    Olympus Corporation of the Americas (Westborough, MA)
    …specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and ... the development of statistically sound design verification protocols/reports, design validation , and delivery system qualification activities + Lead the system… more
    Olympus Corporation of the Americas (06/28/25)
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  • Principal Process Engineer - OPEX

    Cardinal Health (Chicopee, MA)
    …of CI, and mentor junior engineers and technicians. + **Regulatory** **and Validation -** Lead or Support IQ/OQ/PQ activities, risk assessments, and documentation to ... ensure compliance to FDA , ISO13485, and internal QMS requirements. **_Qualifications_** + Bachelor's...Project is preferred + Experience with medical device process validation (IQ/OQ/PQ) preferred + Experience with automated manufacturing systems,… more
    Cardinal Health (06/19/25)
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  • Senior Systems Engineer

    Hologic (Marlborough, MA)
    …in this role, you'll need expertise in: + **Medical Device Compliance:** Proficiency in FDA QSR (21 CFR Part 820), ISO 13485, and design controls. + **Systems ... Leadership:** Ability to lead subsystem architectural discussions, verification and validation testing, and troubleshooting. + **Collaboration:** Proven experience in… more
    Hologic (06/17/25)
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  • Associate Medical Director, Pharmacovigilance…

    Sumitomo Pharma (Boston, MA)
    …signal management throughout product lifecycle including signal detection, signal validation , signal escalation, development of risk mitigation strategies and ... aggregate review of post-marketing safety data in support of safety signal validation , trend detection, risk benefit management, and development of risk mitigation… more
    Sumitomo Pharma (05/16/25)
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  • Specialist, Lead Manufacturing Associate, Cell…

    Bristol Myers Squibb (Devens, MA)
    …their work. + Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. + Must… more
    Bristol Myers Squibb (07/24/25)
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  • Manufacturing Associate II, Cell Therapy

    Bristol Myers Squibb (Devens, MA)
    …their work + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing is preferred.… more
    Bristol Myers Squibb (07/24/25)
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  • Data Science Engineer

    Takeda Pharmaceuticals (Lexington, MA)
    …and best practices for data transformation, data integrity, test design, validation , and documentation; Integrate commercial data (sales, claims, prescription, payer ... new product and implement a new REMS module in TrackWise, as required by FDA ; Implement the Reltio MDM process across multiple countries for a major US healthcare… more
    Takeda Pharmaceuticals (07/19/25)
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  • Sr R&D Process Development Engineer

    J&J Family of Companies (Danvers, MA)
    …internationally ~5% of the time. **Strongly Preferred Qualifications** : + Experience in FDA Class II and III medical devices preferred. + Experience in equipment ... and tooling design, fabrication, process development, and validation . + Hands on experience in prototyping in pilot manufacturing and rapid prototyping; basic… more
    J&J Family of Companies (07/19/25)
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