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    Process Engineer - Seattle, United States - Alpine Immune Sciences, Inc.

    Alpine Immune Sciences, Inc.
    Alpine Immune Sciences, Inc. Seattle, United States

    2 weeks ago

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    Description
    Alpine Immune Sciences is seeking a highly motivated individual to join the CMC team as a Process Engineer (Upstream).

    This individual will be part of a team working to develop upstream processes that are robust, scalable, well characterized, and economical for clinical and commercial manufacturing.

    The successful candidate should have experience in cell culture, cell culture and perfusion manufacturing unit operations and be able to interact with Alpine's network of external CDMOs.

    This is a Hybrid role that will be based out of our Seattle, WA office.

    Duties and responsibilities:


    • Apply a fundamental understand of mammalian cell culture operations including single-use bioreactors and perfusion and harvest technologies to support technology transfer and scale-up of clinical/commercial manufacturing processes.
    • Apply a good understanding of engineering principles for the scaling of cell culture unit operations from bench to manufacturing scale.
    • Provide floor support/person-in-plant for manufacturing activities during clinical and validation campaigns (travel may be required)
    • Work with external vendors (CDMO) and provide leadership/guidance in solving clinical and commercial drug substance process issues involving equipment, scale and raw materials.
    • Experience with statistical Design of Experiments and/or Quality by Design.
    • Experience with risk assessments (FMEA)
    • Develop process knowledge and ownership.
    • Authors technical documents, including technical reports and protocols.
    • Participate in cross functional teams and represent Upstream CMC.
    Qualifications:


    • B.S (M.S./ Ph.
    D. a plus) degree in an Engineering or Scientific field with 4 years or more industry experience in cell culture process development, characterization and/or commercial process support.


    • Experience with scaling up unit operations with an understanding of cGMP requirements, FDA, and ICH guidelines.
    • Experience in communicating and presenting complex technical information to internal and external teams.
    • Self-motivated, ability to muti-task, and a desire to acquire new technical skills.
    • Flexibility to change project objectives and enthusiasm.
    • Excellent written and verbal communication skills.
    • Works well independently and in teams in a highly dynamic, cross-disciplinary environment.
    #LI-hybrid

    At Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Professional level position, with a compensation range of $100,000 - $115,000. Note that candidates must be located in WA state.

    We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans.

    We believe quality time outside the office is vital to our employees' satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed.

    Alpine team members enjoy competitive salaries and equity participation (stock options).
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