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Downstream Process - Scientist III

Indianapolis 100K - 115K Permanent

Job Responsibilities:

  • Lead the establishment of a downstream platform for lentiviral and retroviral vector processes, progressing from small scale to intermediate scale (up to 50L).
  • Continuously monitor process performance, identifying areas for improvement to enhance process efficiency, product safety, and quality.
  • Support initiatives to optimize processes for increased robustness, cost reduction, and improved viral yield and purity.
  • Independently design and execute experiments, accurately recording, analyzing, and communicating findings to senior management and team members.
  • Foster open communication within the team and with stakeholders through one-on-one and group meetings.
  • Stay updated on emerging technologies, identifying and integrating innovative approaches to improve process development.
  • Lead the design, selection, and implementation of single-use systems for upstream bioreactor and downstream unit operations.
  • Develop and maintain SOPs for downstream processes to ensure consistent and high-quality operations.
  • Oversee the process transfer between clients and in-house manufacturing, ensuring seamless transitions.
  • Maintain relationships with external suppliers and collaborate on equipment and material needs.
  • Serve as the subject matter expert (SME) for regulatory audits and client interactions.
  • Ensure a safe working environment and compliance with OSHA, EHS, Quality, and cGMP regulations within the functional area.

Qualifications:

  • BS, MS, or PhD in Biological Engineering or related field
  • 5-8 years of relevant industry experience
  • Strong foundation in biochemical engineering, virology, and cell biology
  • Experience in technical support for cGMP manufacturing and/or process development within the pharmaceutical industry
  • Hands-on experience with cell culture technologies, molecular biology, upstream processing, and aseptic processing
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