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Latitude, Inc. Manufacturing, Science, and Technology Engineer in Gaithersburg, Maryland

Manufacturing, Sciences, and Technology Engineer who is responsible for technical oversight of external development and manufacturing activities for vaccine drug substances (DS). The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

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 both our client and 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