Medical Regulatory Process Engineer
6 days ago
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.
- 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).
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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