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  • Drug Product Tech Transfer Manager, MSAT
    Gaithersburg, MD

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  • Job Description

    This is an exciting opportunity responsible for overseeing Manufacturing Sciences & Technology (MS&T) related drug product and fill/finish technology transfer and manufacturing activities for biologics manufacturing. You will be charged with overseeing the following activities:

    * Leading MSAT staff and projects relating to drug product manufacturing operations.
    * Providing technical leadership and subject matter expertise relating to drug product fill & finish related deviations, change control, process optimization, and technical troubleshooting.
    * Handling of complex and highly automated systems and overseeing all state-of-the-art equipment including formulation, aseptic liquid filling, pre-filled syringe lyophilization, and  packaging apparatus.
    * Working cross functionally with Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments to lead drug product fill & finish related process improvement, process validation, process change control, deviation investigation and process characterization activities. 
    * Serving as a technical/scientific Subject Matter Expert drug product fill & finish activities.
    * Defining, designing and developing critical process capability, critical process parameters, and process performance measurements through multivariate modeling and statistical measurements of Cp, Cpk, Pp, and Ppk.
    * Training engineering staff on cGMP compliance and SOPs including writing/reviewing batch records, process validation documents, and sections of regulatory filings.
    * Assisting in the build-out of BioPharma Manufacturing Data Systems, Process Intelligence, and Process Monitoring systems.

    Desired Skills and Experience

    * BS in Biochemical Engineering, Chemical Engineering, Biochemistry, Biology, Chemistry or related Life Sciences/Engineering field.
    * 6-10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
    * Experience leading projects relating to manufacturing deviations, change control, process optimization, technical troubleshooting, and manufacturing process changes.
    * Experience with high speed aseptic liquid filling of vials, aseptic lyophilization filling of vials, and aseptic preparation of pre-filled syringes through capping, bottling, and packaging processes.
    * Strong experience working cross functionally within a BioPharma Manufacturing organization leading projects across Process Development, Manufacturing, Regulatory, Quality, and Engineering Services departments.
    * Strong Scientific and Engineering technical experience performing fill & finish manufacturing activities from formulation through packaging activities. 
    * Expertise involving QbD (Quality by Design), scale down studies, process range studies, PAT, statistical analysis, process robustness studies, and Six Sigma.
    * thirty

    About this company

    This is a stellar opportunity within an expanding Maryland based BioPharmaceutical company with an expansive commercial biologics product portfolio and promising development pipeline. 
    Apply Here: by dragging your Microsft Word resume into this yellow box.
    OR you can click the green Apply Now button on the top right of this page to browse for the file.

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