• Associate Principal Scientist

    Organon & Co. (Plymouth Meeting, PA)
    …assigned products across the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
    Organon & Co. (07/22/25)
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  • Principal Scientist , Regulatory

    Organon & Co. (Plymouth Meeting, PA)
    **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( ... portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals...will directly support projects and/or coordinate with Regulatory CMC scientists in the Organon franchise… more
    Organon & Co. (07/22/25)
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  • Associate Principal Scientist

    Organon & Co. (Plymouth Meeting, PA)
    …+ Execute regulatory strategies by developing, authoring, and reviewing CMC submission components and documentation to support post-approval supplements, ... strategies for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes… more
    Organon & Co. (07/30/25)
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  • Distinguished Scientist , CMC Team…

    J&J Family of Companies (Malvern, PA)
    …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... are searching for the best talent for a Distinguished Scientist , CMC Team Leader, Proteins to be...development improvements across the TDS organization. They may also support or lead teams in implementing initiatives to deliver… more
    J&J Family of Companies (07/30/25)
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  • Distinguished Scientist , CMC Team…

    J&J Family of Companies (Malvern, PA)
    …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... are searching for the best talent for a** **Distinguished Scientist , CMC Team Leader, Protein Conjugates** **to...development improvements across the TDS organization. They may also support or lead teams in implementing initiatives to deliver… more
    J&J Family of Companies (07/26/25)
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  • Sr Scientist

    Teva Pharmaceuticals (West Chester, PA)
    …teams, with ability to build cross-departmental relationships * Knowledge of CMC requirements for regulatory submissions (INDs, BLAs) and experience ... Sr Scientist Date: Aug 1, 2025 Location: West Chester,...multidisciplinary team advances biologics and biosimilars. Within Teva, Biologics CMC oversees biologic product development from IND submission through… more
    Teva Pharmaceuticals (08/02/25)
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  • Principal Scientist , Engineering…

    Merck (West Point, PA)
    …and influences process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC ... transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The… more
    Merck (08/08/25)
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  • Scientist II or III Bioanalytical Assay…

    Parexel (PA)
    We are looking to fill a Bioanalytical Scientist position working as **a full-time employee of Parexel FSP on long-term assignment** onsite at one of our clients ... + Develop and qualify cell-based or ligand-binding based bioanalytical assays to support high priority biological and vaccine programs. + Analyze samples using… more
    Parexel (08/02/25)
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  • Sr. Scientist , Small Molecule Analytical…

    Merck (West Point, PA)
    …scale-up and validation support , preparation of Chemistry, Manufacturing, and Controls ( CMC ) documents for global regulatory submissions, and responses to ... and Supply (ACDS) is seeking applicants for a Senior Scientist position available at the Rahway, NJ and West...method development and validation + Familiarity with authoring relevant CMC sections of regulatory submissions Current Employees… more
    Merck (08/08/25)
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  • Principal Scientist , Cell Culture…

    Merck (West Point, PA)
    …with multiple agencies (FDA, EMA, JNDA, TGA). + **Leadership:** Establish, manage and support CMC teams, and align resources to deliver on priorities. Manage ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + ** CMC RA** : Experience supporting/writing… more
    Merck (08/01/25)
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