Senior Process Engineer

3 days ago


South San Francisco, California, United States Cellares Full time
{"title": "Senior Process Engineer", "content": "Job Summary

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

Key Responsibilities
  • Support technology transfer activities at the site level, including scale-up and process adaptations.
  • Lead and/or support late-stage process development activities, including characterization, comparability, and qualification/validation.
  • Own the technology transfer from Process Development to cGMP Manufacturing operations, authoring change records, drafting/reviewing/approving SOPs and batch records, and training manufacturing personnel.
  • Support the development of manufacturing operations and business processes, including GMP system implementation and tasks related to GMP readiness.
  • Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies.
  • Provide user needs, requirements, and support implementation and UAT of Cellares software solutions.
  • Own root cause investigations and train manufacturing personnel to support robust root cause analysis.
  • Facilitate complex cross-functional investigations and propose and implement corrective and preventive actions.
  • Develop training and onboarding content and curriculum for new hires and new methods.
  • Maintain and report process run summaries and continued process verification reports.
  • Prepare and present data associated with manufacturing processes to internal and external partners, as well as health authority inspectors.
  • Support process qualification and validation preparation, execution, monitoring, and reporting.
Requirements
  • Bachelor's Degree in a scientific or related field.
  • A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy.
  • Experience with technology transfer in the Pharma/Biotech industry.
  • Strong analytical, problem-solving, and critical thinking skills.
  • Excellent teamwork and interpersonal skills.
  • Experience with Operational Excellence and/or Lean Manufacturing is a plus.
About Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. We are headquartered in South San Francisco, California, with our commercial-scale IDMO Smart Factory in Bridgewater, New Jersey.

", "company": "Cellares", "location": "South San Francisco, California", "salary": "$90,000 - $210,000 a year"}

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