Process Engineer

3 days ago

San Diego, California, United States LENZ Therapeutics Full time
Job Title: Process Engineer

LENZ Therapeutics is a leading biopharmaceutical company dedicated to developing innovative ophthalmic pharmaceutical 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).
  • Main technical point of contact between LENZ and external manufacturing and analytical partners.
  • 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 NDA and regulatory filing support for CMC-related sections, including Drug Substance, Drug Product, Analytical, and Stability data.
  • Apply statistical methods to various production performance datasets to monitor, track, and trend, and/or assess opportunities for improvement in capacity, yield, and/or utilization, as well as KPI reporting.
  • Collaborate with external partners to troubleshoot and investigate issues that arise within the manufacturing process and effectively communicate findings in a timely manner.
  • Coordinate with CMOs on product process design changes and process improvements to manage product life cycle and CMC risk management.
  • Support Drug Product batch record review and disposition activities with LENZ's Quality Assurance team.
  • Technical support for technology transfer and process/equipment scale-up activities with primary and secondary/tertiary suppliers.
  • Support analytical method transfers and validation to secondary/tertiary contract laboratories.
  • Coordinate manufacturing and testing schedules with CMOs for clinical, registration, process validation, and commercial batch execution.
  • Write and review technical documentation (batch records, SOPs, protocols & reports).
  • Perform data analysis based on clinical MFG process and commercial product data.
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.
  • Experience working with analytical Labs and vendors for both clinical and commercial drug products.
  • 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.
  • Demonstrated ability to multi-task and execute work in a timely manner within a fast-paced environment.
  • Ability to drive multiple initiatives at one time in a fast-moving environment where the expectations to always deliver results will be high.
  • Strong team player and a demonstrated track record of playing a key role in a business environment.
  • Strong communicator that has shown to be able to both verbally and in written word adapt to the style of communication appropriate to their intended audience.
  • Strong computer skills including Microsoft Excel, Word, PowerPoint, and knowledge of ERP/MRP systems.
  • BS or BA in Chemistry, Biology, Chemical Engineering, Engineering, or similar.
  • 5-7 years of biopharmaceutical experience.

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