Atef Khezri

A very hands-on leader with 18 years of FDA manufacturing leadership experience, from a well-established pharma giant to a startup CDMO. Passionate about problem solving and coaching my team on leadership qualities and traits. Love to take on challenges, always thinking outside of the box, with positive attitude and relentlessly looking for opportunities to improve quality, cutting waste, making the operation more efficient, and inspiring my team to meet and exceed key performance indicators.

• Co-authored an article on “Approaching Viral vector manufacturing with an emphasis on Quality and Design” published on Pharma’s Almanac on May 10th 2022

Avid Bioservices

• Implemented robust daily management meetings and task sheets to closely monitor downstream manufacturing and coached the managers on troubleshooting and minimizing process and equipment downtime to maximize productivity, as a result reduced downtime from average of 20 hours to 5 hours per batch.
• Implemented and trained manufacturing on a template to capture quality events description real time to optimize the robustness in root cause analysis and the deviations closure process.
• Successful PAI inspection outcome by the PMDA (Japanese regulatory agency) with zero manufacturing findings on a client commercial product.
• Discovered irregular accounting and invoicing practices against the contractual agreements with 2 different vendors and saved total of $500K on fixed annual operating cost.

Catalent Pharma Solutions

• Expanding capacity for buffer, media prep in formulation, by acquiring the necessary qualified equipment and mixing supplies to accommodate the ramp up of production.
• Participated in all the EMPQ activities for suites 1-10 and release of GMP suites around the clock and bringing them online.
• Worked closely with PAI readiness team, represented Manufacturing during PAI audit with clients and FDA with no major findings.
• Implemented Tier meetings at Biopark and BWI sites, and effectively monitoring our key daily metrics.

Merck

• Received an excellence award from the executive director for outstanding performance for reaching the highest manufacturing output for Gardasil Franchise for 2018.
• Received an award from the executive director for having zero observations during an audit.
• Received an Award from the plant manager & manufacturing manager for improving the overall plant efficiency to an all-time high of 103% against the forecast.
• Managed the WIP and discovered how to speed up the rate of packaging machine within the validated parameter on one of the bottlenecks on the Infusor line and increased TP to record high.