Medical Regulatory Process Engineer

6 days ago


United PA, United States Resilience Corp. Full time
Job Summary

We are seeking a highly skilled Medical Regulatory Process Engineer to join our team at Resilience Corp. in Philadelphia, PA. As a key member of our Manufacturing Science and Technology (MSAT) group, you will provide technical support to our CMP Manufacturing operations and play a critical role in ensuring the success of our cell therapy production.

Key Responsibilities
  • Support cell therapy production by leading the introduction of new manufacturing processes to the facility for clinical and commercial manufacturing of cell therapy products.
  • Perform technology transfer from the development laboratory into all phases of GMP manufacturing.
  • Support the design, test, and qualification of MES recipes for electronic batch records.
  • Support process investigations, equipment and process troubleshooting.
  • Identify and drive implementation of improvements to maximize throughput and capacity utilization.
  • Provide support and content for regulatory submissions.
Requirements
  • Bachelor's degree in Life Sciences, Chemical or Biological Engineering, or related discipline.
  • 3-5 years of relevant industry experience in process development, technology transfer, or GMP Manufacturing.
  • Experience in the scale up and operation of cell / gene therapy manufacturing practices.
  • Hands-on experience cell and/or gene therapy biotechnology unit operations.
  • Experience working for or with contract manufacturing organizations.
  • Experience with digital Manufacturing Execution Systems (MES).
What We Offer

Resilience Corp. offers a comprehensive total rewards program, including equity, an annual cash bonus program, a 401(k) plan with a generous company match, and a benefits package that supports our employees' well-being and career growth.



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