Senior Process Engineer

3 days ago


Bridgewater NJ USA, United States Cellares Full time
Job Summary

We are seeking a highly skilled Senior Process Engineer to join our MSAT team at Cellares. As a key member of our team, you will play a crucial role in the development of our advanced cell therapy manufacturing platform.

Key Responsibilities
  • Support the development of manufacturing operations, including GMP system implementation and tasks related to GMP readiness.
  • Lead activities to transfer processes to manufacturing from internal Cellares process development at other sites or directly from customers.
  • Develop and review relevant SOPs for manufacturing operations and systems.
  • Perform manufacturability assessments for new process introductions.
  • Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies.
  • Work with our software team on integration solutions for the manufacturing process and data management, including eBR, MES, QMS, and LIMS.
  • Provide technical leadership to Manufacturing and other departments associated with GMP operations.
  • Assess all major deviations including those that impact product quality.
Requirements
  • Bachelor's Degree in a scientific or related field is required.
  • A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy.
  • Experience in the Pharma/Biotech industry in technology transfer.
  • Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.
  • Adherence to cGMPs is required all times during the manufacture of Cell Therapy products.
What We Offer

Cellares offers a competitive total compensation package, including a base salary range of $90,000 - $210,000 per year, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options.



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