Director of Downstream Process Development

    Updated today
    Raleigh, NC 27676
    Full-time, Part-time
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    Job Description

    Job Title: Director of Downstream Process Development

    Location: Durham, North Carolina

    Salary: DoE


    • Manage staff in Downstream Process Development.
    • Responsible for day to day technical supervision of the downstream scientists and associates.  Serve as in-house advisor on key scientific discipline areas.
    • Be an expert in downstream process technologies. Innovate and spearhead development of downstream process technologies that can result in significant increases in efficiency and purity.
    • Operate within a cross-functional project team environment and coordinate efforts with all relevant internal functional areas including Quality, Manufacturing, Upstream Process Development, Program Management, Analytical Development, Formulation Development.
    • Have direct experience with establishing downstream processes for biologics in cGMP manufacturing settings.
    • Guide staff in building scalability attributes into downstream processes.
    • Experience throughout the biopharmaceutical product life cycle including process characterization studies, in-process control strategy and process validation.
    • Coach and develop a highly talented and motivated staff base.
    • Experience in operating in a client driven environment and communicating results and strategies cogently to a diverse audience.



    • Full responsibility for the direction of all downstream process development activities.
    • Evaluate, develop and implement new downstream technologies leading to process improvements and efficiency of operation or enable company to showcase the excellence of our development operations. Publish papers in leading journals and present at key industry conferences as applicable.
    • Assist in attracting new clients to company through presenting and showcasing KBl's technical and scientific capabilities as they apply to potential client projects. Support the development of appropriate proposals by interfacing with Business Development.
    • Create working plans within DSP team to manage program load and resources & equipment.
    • Develop and maintain budgets, manpower and capital requirements for downstream process development and manufacturing areas. Develop and monitor performance criteria to allow measurement and continuous improvement of efficiency and quality, thereby ensuring meeting of committed targets of on-time and error-free performance.
    • Lead, assess, coach, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
    • Assure cGMP success through effective tech transfer and support of cGMP manufacturing. Coordinate efforts with manufacturing to achieve program success.
    • Determine areas for gaining efficiency, coordinate with individual groups and ensure harmonized implementation of best practices.
    • Document all activities according to the appropriate laboratory procedure and/or standard operating procedures.



    Minimum requirement is a Bachelor of Science degree in a scientific discipline with a minimum of 15 years of technical management experience; a Master's degree with 13 years or a Doctorate degree in a scientific or biochemical engineering area (or equivalent) and at least 8 years related experience and/or training preferred. Additionally, at least 5 years’ experience serving in a relevant managerial capacity required.

    • Must have knowledge of GMPs and biotechnology-derived product regulations.
    • Also requires a demonstrated track record in the following key areas:
    • Knowledge of downstream process development for biologics
    • Ability to multi-task and handle successful execution of multiple parallel programs
    • Knowledge of cGMP and manufacturing operations
    • Knowledge of tech transfer
    • Knowledge of good lab practices including hands on implementation
    • Knowledge of regulatory guidelines, particularly those for IND filing.


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    Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

    About Kelly®

    At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

    Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

    Posting ID: 609326330Posted: 2021-05-06Job Title: Director Downstream Process Development