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Biopharmaceutical Manufacturing Specialist

1 month ago


Norwood, Massachusetts, United States Randstad Full time
Job Summary

Randstad is partnering with a leading pharmaceutical company to recruit a skilled Biopharmaceutical Manufacturing Associate to support GMP Manufacturing of biopharmaceuticals in Norwood, MA.

The successful candidate will be part of a cohesive team responsible for producing GMP mRNA-based personalized medicine for evaluation in human clinical trials. They will apply existing and new knowledge of bioprocess unit operations and cGMPs to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations.

This is a contract-to-hire opportunity with multiple shift options available. Candidates should have relatively open work availability to meet the business needs.

Key Responsibilities:

  • Execute manufacturing operations using disposable technologies, automation, and Manufacturing Execution Systems (MES)
  • Develop batch records, SOPs, and training materials for the startup of the Norwood Facility
  • Closely partner with QA peers for rapid disposition of personalized cancer vaccines
  • Demonstrate general knowledge of standard manufacturing practices and equipment
  • Strictly adhere to current good manufacturing practices, standard operating procedures, and manufacturing documentation
  • Monitor process operations to ensure compliance with specifications
  • Assist in the investigation of procedural deviations
  • Practice safe work habits and adhere to Moderna's safety procedures and guidelines

Requirements:

  • 2 years of experience in GMP manufacturing
  • Experience with sterile manufacturing and biopharmaceuticals
  • Knowledge of Quality Assurance and cGMPs

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