Process Development Scientist

1 month ago


Morrisville, United States Barrington James Full time

Process Development Scientist/Senior Scientist


I am partnered with an innovative and exciting biotech company specializing in wound care and ophthalmology. I am working closely with the CTO, who is seeking a passionate scientist to operationalize aseptic GMP manufacturing for their complex biologic products. You will be responsible for ensuring the timely and accurate completion of manufacturing setup, including cleanroom, equipment, process flow, relevant standard operating procedures, sterilization logistics, and more.


Main Responsibilities:

  • Setting up cleanrooms and generating relevant manufacturing standard operating procedures.
  • Designing and validating clear processes to manufacture products under full cGMP compliance.
  • Integrating engineering and life science theories into product development.
  • Optimizing per batch yield through process improvements.
  • Implementing steps to enhance manufacturing efficiency.
  • Coordinating with the Development Team to facilitate assay development and relevant data collection.
  • Leading the hands-on technology transfer, manufacturing, and validation/qualification of processes and equipment.
  • Creating reports, updating stakeholders, and contributing to regulatory filings.


Qualifications:

  • Degree in a relevant field with over 6 years of experience in biologics.
  • GMP experience.


Please note that we are unable to provide sponsorship for this role at this time.


Apply today to learn more or send your resume to rbanton@barringtonjames.com



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