Manufacturing Technical Lead

1 day ago

Lexington, Kentucky, United States Genezen Full time
About the Role

Genezen is seeking a highly skilled and experienced Manufacturing Technical Lead to join our team. As a key member of our manufacturing operations, you will be responsible for overseeing and executing our therapeutic manufacturing processes in compliance with Good Manufacturing Practices (GMP) regulations.

Key Responsibilities
  • Oversee and execute Genezen's therapeutic manufacturing processes in compliance with GMP regulations, ensuring the highest standards of quality, safety, and efficiency.
  • Lead process optimization efforts, driving continuous improvement initiatives to enhance productivity, reduce waste, and minimize downtime.
  • Act as the point of contact for Tech Transfer and collaborate with cross-functional teams to ensure smooth process transfer and scale-up from development to commercial production.
  • Collaborate with compliance and documentation teams to provide technical expertise and feedback during the revision of documents.
  • Conduct thorough process evaluations, identify areas for improvement, and implement corrective actions as needed.
  • Monitor and analyze key process metrics, such as yield, cycle time, and equipment utilization, to identify trends and drive process optimization strategies.
  • Support Supervisors in generating Bill of Materials (BOMs) and requesting materials for non-commercial products.
  • Ensure efficient use of material and equipment.
  • Act as backup for the monthly meeting lead for Tier 1 meetings and own the Continuous Improvement board at Tier 1.
  • Act as the primary contact for Supervisors regarding troubleshooting and issue resolution.
  • Be well-versed in all areas of the Manufacturing process.
  • Create and follow-up on work requests in Blue Mountain.
  • Ensure accurate documentation, timely review, maintenance, and submission to Quality Assurance for stand-alone forms and logbooks in their respective area/process.
  • Communicate safety concerns and collaborate with EHS and Supervisors to drive resolution.
  • Provide personnel feedback to leadership team.
  • Ensure staff compliance with all relevant SOPs, BPR's, SLR's and safety guidelines.
  • Act as a role model (Lead by Example) and Act as a resource/SME for MFG staff.
  • Ensure the use of safe work practices and behaviors.
  • Develop and schedule supplemental training sessions in the pilot plant or idle rooms on the MFG floor.
  • Identify MFG technicians training needs and gaps, collaborating with the Training Coordinator to develop and deliver relevant training programs such as OJT training.
  • Coordinate training sessions with MSAT & Compliance teams to ensure MFG team members receive proper technical and compliance training.
  • Provide hands-on training and mentoring to manufacturing personnel, ensuring they possess the necessary skills and knowledge to execute processes accurately and efficiently.
  • Stay updated with industry advancements, new regulations, and best practices related to GMP manufacturing processes, and share relevant information with the team.
  • Develop and maintain MFG operators' qualification data such as Fill qual, VI qual, Vision acuity and media fill.
  • Work with quality assurance to develop and maintain visual inspection library and kit.
  • Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause.
  • Support MFG supervisors with Excursion assessments, CMS assessments, LE's and OOTs.
  • Create, update and maintain MFG Pre-Job brief guide.
  • Ensure staff compliance with all relevant SOPs, BPRs, SLRs, and safety guidelines.
  • Work with MFG supervisors and team leads to Implement appropriate corrective actions.
  • Review GMP documentation daily and escalate as needed.
Requirements
  • Adaptability required as work schedule may change based on business needs.
  • Criminal background check required.
  • Other duties as assigned.

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