• Lead Specialist, QA Validation & Engineering

    Catalent Pharma Solutions (Harmans, MD)
    …standards and Catalent policies/procedures supporting the commercial GMP manufacturing of biological drug substance and drug product. This position will ... departments of a CMO for Phase I/II/III GMP manufacturing of biologic bulk drug substance and sterile finished drug product. The anticipated salary range for… more
    Catalent Pharma Solutions (05/22/25)
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  • Lead Specialist, QA Batch Disposition

    Catalent Pharma Solutions (Harmans, MD)
    …providing Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance and finished drug product. **Position Schedule:** ... compliance. + Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product. + Other duties, as assigned. **The… more
    Catalent Pharma Solutions (05/11/25)
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  • Quality Control Analyst II

    Abeona (Cleveland, OH)
    …Practices (GMP) testing for Quality Control (QC). Performs in-process and release testing for drug substance and drug product. Supports the authorship and ... gram stain, bioburden, rapid sterility testing, and visual inspection of the drug substance and drug product using standard techniques in biochemistry,… more
    Abeona (04/22/25)
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  • Principal Research Scientist II, Early Phase…

    AbbVie (North Chicago, IL)
    …experienced analytical scientist to support early phase development of New Chemical Entities (NCEs) drug substance and drug product in both preclinical and ... + Mentor analysts on the development of phase-appropriate analytical strategies involving Drug Substance and Drug Product and support the development of NCE… more
    AbbVie (04/16/25)
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  • Advisor Research Scientist (Synthesis) - ADN Ramp…

    Lilly (Indianapolis, IN)
    …the value chain and in multiple locations + Understanding the interaction of bulk drug substance and drug product formulationinteraction of equipment set(s) ... with process ( drug substance and drug product) + Significant experience with registration, including authoring of technical reports, Development History… more
    Lilly (03/13/25)
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  • Inventory Control Associate

    Insight Global (Bothell, WA)
    …GMP material, receiving, inspection, storage, transferring and issuing inventory of materials, drug substance in intermediates, governed by SOPs. The Inventory ... samples with external contract sites. Responsibilities: Principal Responsibilities Ship GMP bulk drug substance , intermediates, and QC samples with IATA/DOT 19… more
    Insight Global (05/11/25)
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  • Senior Director of Analytical Development - SMDD

    Lilly (Indianapolis, IN)
    …for delivering an ambitious portfolio across different modalities, therapeutic areas, and drug substance / drug product. **Key Responsibilities** _People ... with 10+ years of experience in analytical development and commercialization of drug substances and drug product ( _Will also consider a MS Degree in Organic… more
    Lilly (05/06/25)
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  • Supervisor, QA Operations - Nights

    Fujifilm (Holly Springs, NC)
    …is responsible for providing supervision and risk-based QA support for the Drug Substance Manufacturing areas and processes. **Company Overview** FUJIFILM ... open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one… more
    Fujifilm (04/03/25)
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  • Scientist: ELISA

    ThermoFisher Scientific (East Syracuse, NY)
    …methods for the testing of raw materials, excipients, biologics and other modalities in-process, drug substance , and drug product samples. The candidate will ... used in the testing and characterization of raw materials, excipients, in-process, drug substance , and drug product samples including qPCR, ELISA, CE-SDS,… more
    ThermoFisher Scientific (04/29/25)
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  • Formulation Scientist - Regulatory Affairs

    Eurofins (Indianapolis, IN)
    …research and development or formulation role focused on large molecule/biologics drug substance /product development. + Pharmaceutical industry experience in CMC ... technical drug development ( drug substance and/or drug product experience in analytical development or formulation). Preferred but Optional: + Three or… more
    Eurofins (04/17/25)
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