Manufacturing Technical Lead - Genezen

JOB SUMMARY

With minimal supervision this individual will deliver excellence in manufacturing processing as well as training others to meet site demands. Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into manufacturing.

ESSENTIAL JOB FUNCTIONS

• 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 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.
• Should 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.

People:

• 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

Training:

• 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.

Quality:

• 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

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Frequently required to work in a GMP clean room environment with personal protective equipment/aseptic gowning
• Regularly required to work around equipment and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to loud noise levels
• Spending time on the floor during activity execution is required

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 25 pounds
• Occasionally lift and/or move up to 40 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus
  Communication
• Frequently required to communicate by talking, hearing, using telephone and e-mail