Process Development Engineer Transformation Specialist
6 days ago
We are seeking a skilled Process Development Engineer to join our team, bringing expertise in biotech, cell culture, and purification processes for process improvement and technical support roles.
Key Responsibilities:
- Develop and implement efficient process development strategies for laboratory-to-manufacturing facility transfer of cell culture and/or purification drug substance processes.
- Collaborate with cross-functional teams to drive process improvements, ensuring seamless scale-up and technology transfer for clinical/commercial manufacturing operations.
- Provide technical support for late-stage commercial processes, offering process validation expertise and routine process monitoring/troubleshooting services.
- Drive data-driven decision making through statistical process analysis and data trending.
To be successful in this role, you will require:
- A Bachelor's degree in Chemical or Biochemical Engineering, complemented by 2 years of experience in GMP environments.
- 1+ years of Process Engineering experience, preferably related to scale-up principles and commercial cGMP manufacturing facilities.
- A background in biologics tech transfer into commercial facilities, with knowledge of purification and cell culture processes/equipment.
- Experience working with cell culture bioreactors and purification processes/equipment, including chromatography, UF/DF, and scale-up factors.
This is a competitive opportunity with an estimated salary range of $27.00 to $36.00 per hour.
Our comprehensive benefits package includes medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, commuter benefits, and a 401K plan, providing flexibility to choose coverage that meets individual needs.
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