Lead Bioprocess Engineer - Scale-Up & GMP Operations

Growmark

St. Louis (MO)

On-site

USD 140,000 - 160,000

Full time

10 hours ago
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Job summary

AgraForm Biologicals, LLC in St. Louis, MO, seeks a Principal Bioprocess Engineer to lead design, start-up, scale-up and optimization of fermentation and downstream processes.

You will serve as SME for bioprocess systems, drive CAPA, QMS, and regulatory compliance, and collaborate across cross-functional teams to ensure safe, reliable operations. The role requires advanced degree and 7+ years in bioprocess engineering in regulated manufacturing; strong communication and project leadership are

Qualifications

  • Bachelor's degree in chemical engineering or related field; 7+ years bioprocess experience preferred.
  • Experience with fermentation, downstream processing, and scale-up from bench to commercial.
  • Experience in regulated manufacturing with CAPA, deviations, and quality systems.

Responsibilities

  • Lead equipment qualification (IQ/OQ/PQ) for fermentation and downstream equipment.
  • Design, optimize, and scale-up fermentation across bioreactor platforms.
  • Establish CPPs/CQAs for microbial product lines; support CAPA.
  • Lead root-cause analysis and CAPA implementation for deviations and contamination.
  • Ensure process designs comply with EHS and regulatory requirements.

Skills

Analytical skills
Problem solving
Communication
Team collaboration
Industrial familiarity

Education

Bachelor's degree in chemical engineering
Master's degree or PhD preferred

Tools

Bioreactor platforms
DoE planning

Job description

AgraForm Biologicals, LLC in St. Louis, MO, seeks a Principal Bioprocess Engineer to lead design, start-up, scale-up and optimization of fermentation and downstream processes.

You will serve as SME for bioprocess systems, drive CAPA, QMS, and regulatory compliance, and collaborate across cross-functional teams to ensure safe, reliable operations. The role requires advanced degree and 7+ years in bioprocess engineering in regulated manufacturing; strong communication and project leadership are

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