Process Engineer

2 weeks ago


San Diego, California, United States LENZ Therapeutics Full time
Job Summary

LENZ Therapeutics is a leading biopharmaceutical company dedicated to developing innovative ophthalmic products that improve vision. We are seeking an experienced Process Engineer to join our dynamic team as we prepare to commercialize our lead asset LNZ100.

Key Responsibilities
  • Provide technical support to GMP operators at Contract Manufacturing Organizations (CMOs) as Person-In-Plant (PIP).
  • Oversee manufacturing and analytical testing activities, including API production, Drug Product formulation and filling, release testing, and stability program oversight.
  • Support cross-functional teams in troubleshooting and resolving manufacturing-related issues, problem-solving, CMC risk assessments, and development of improvement plans.
  • Provide regulatory filing support for CMC-related sections, including Drug Substance, Drug Product, Analytical, and Stability data.
  • Apply statistical methods to production performance datasets to monitor, track, and trend opportunities for improvement in capacity, yield, and utilization.
Requirements
  • Strong background in cGMPs, Manufacturing, Analytical, Process Engineering, and/or CMC roles.
  • Experience working at/with a CMO in Drug Substance and/or Drug Product manufacturing roles.
  • Blow-Fill-Seal (BFS) manufacturing experience preferred.
  • Strong understanding of cGMP, 21CFR part 210 & 211, and other regulatory aspects of aseptic compounding and sterile Blow-Fill-Seal manufacturing.
  • Project Management skills and experience, including strong collaboration, organization, communication skills, and results-focused.
What We Offer

LENZ Therapeutics offers a dynamic work environment, opportunities for professional growth, and a competitive compensation package. If you are a motivated and experienced Process Engineer looking to join a leading biopharmaceutical company, please submit your application.


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