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Manufacturing Specialist

2 months ago

New York, New York, United States Astrix Full time
Manufacturing Technician (Night Shift)

Astrix is seeking a skilled Manufacturing Technician to join our team in a contract development and manufacturing organization (CDMO) based in the US. This role offers a great opportunity to contribute to the development and commercialization efforts.

Key Responsibilities:
  • Conduct sterile manufacturing processes in a GMP-compliant cleanroom, adhering to aseptic techniques and ensuring quality standards.
  • Prepare production spaces by performing line clearances, cleaning, and ensuring equipment calibration and system suitability.
  • Gather, organize, and prepare materials required for manufacturing, including managing inventory levels and submitting purchase requisitions for low-stock items.
  • Operate and maintain chemistry machines and automated dispensing systems to ensure timely drug product release.
  • Support manufacturing investigations and technology transfer processes, collaborating with team members to maintain work schedules and calendars.
  • Complete batch records in accordance with Good Documentation Practices (GDP) standards and follow radiation safety protocols during production and preparation.
Requirements:
  • Bachelor's or Associate Degree required, unless there is significant experience in pharmaceutical manufacturing.
  • Strong technical aptitude with the ability to troubleshoot basic mechanical equipment issues and interact with various software programs.
  • Eagerness to learn and openness to feedback, with proficiency in Microsoft Word.
  • Comfort with occupational radiation exposure (training will be provided) and ability to lift up to 50 lbs.
  • Experience with aseptic gowning and cleanroom operations is a plus, as is familiarity with Laboratory Information Management Systems (LIMS).