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Date Added: Wed 26/05/2021

MS&T Engineer- (27)

Gaithersburg, MD, US
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Job Type: Permanent, FullTime

Job Description

Main Focus-

  • Bachelors degree and 2+ years of experience

Responsibilities include, but are not limited to:

    • Partnering with Contract Development and Manufacturing Organizations (CDMOs) to oversee drug substance development and manufacturing activities
    • Provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages
    • Preparing, reviewing, or approving process flow diagrams, development reports, and master batch records
    • Oversee execution of the validation of DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
    • Assisting with the writing and reviewing documents for INDs / regulatory section submissions
    • Prepare, review, or edit validation, CMC regulatory, and Quality documents
    • Collaboration with other CMC team members to build and execute the CMC development plan
    • Trending of drug substance process data, identification and investigation of adverse trends
    • Partnering with CDMO representatives to investigate process and analytical deviations
    • Working closely with project managers at CDMO's to ensure project milestones are maintained

Minimum Requirements:

    • MS or BS in engineering, chemistry, biology, or related discipline, plus at least 2 years of experience in vaccine or biologic manufacturing operations
    • Proven experience in collaborating in matrix teams in a technical environment
    • Strong project management skills and adept at working collaboratively with cross functional teams
    • Strong interpersonal and communication skills
    • Knowledge of protein production and purification manufacturing technologies, such as:
    • Cell culture
    • Shake flasks and stirred tank bioreactors
    • Clarification by depth and tangential flow filtration
    • Column chromatography

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