Chris Abney's Email Addresses & Phone Numbers

📖 Summary

Over 20 years experience in the solid dose, modified release contract manufacturing industry. Worked on countless development and tech transfer projects many of which I managed through validation and commercial launch. Extensive knowledge of cGMPs and industry regulatory trends such as QbD. Interact with customers on a daily basis. Involved in numerous regulatory and customer audits including the FDA, MHRA, Anvisa, and DEA. Developed both beginner and intermediate training programs for various manufacturing processes. Excellent communication skills, both written and oral, that are essential in interacting with both internal and external customers. Experience with Lean manufacturing principles and 5S. Extensive knowledge of the operation and theory behind: o Fluid bed granulation, drying, rotor processing, and Wurster coating o High Shear granulation o Extrusion and spheronization o Pan coating o Encapsulation- powder and pellet o Tablet compressionProduction Manager @ From January 2010 to Present (6 years) Process Optimization Manager @ Process Optimization Manager • Manage a team of 9 SME’s responsible for all tech transfer, scale up, process optimization, and validation projects coming into the site • Provide professional customer service to both internal and external customers • Manage numerous projects simultaneously • Take a proactive approach to project management in order to anticipate issues before they arise • Meet with all potential customers to discuss project scope and timelines • Perform yearly review of all commercial processes in order to determine if there are any opportunities for optimizing batch times, yields, etc. • Defined equipment specifications and user requirements for Catalent Schorndorf plant expansion • Escort and interact with potential clients, customers and agency auditors on plant tours. • Have led two and participated in several Kaizen events around training, process improvements, and equipment changeover • Develop and write manufacturing batch records • Assist in project quotations • Set clear objectives for the team and myself From January 2010 to Present (6 years) Production Manager @ • Responsible for the day to day operation of a 24/7 commercial manufacturing operation overseeing approximately 150 employees • Involved in monthly forecasting and budgetary submissions • Drove batch “right first time” culture • Managed through daily scheduling, manufacturing, and personnel issues in order to maintain a greater than 98% OTD metric • Developed tracking tools used to measure Safety, Quality, Delivery, and Cost as it pertains to the manufacturing area • Wrote standard operating procedures • Worked with the Quality department on deviations, root cause analysis, and implementation of corrective actions From April 2007 to January 2010 (2 years 10 months) Technical Leader @ • Provided technical/ processing assistance to both the client and to the Winchester manufacturing department • Assisted in preparation of timelines, master batch records, protocols, and other project related functions • Operation and troubleshooting of various solid dose manufacturing equipment including fluid beds, high shear granulators, encapsulation machines, tablet presses, pan coaters, blenders, and etc. • Trained and educated personnel about techniques involved in solid dose manufacturing • Ensured that my direct reports performed work accurately and efficiently in order to meet deadlines and quality expectations • Assist in project quotations From January 2001 to April 2007 (6 years 4 months) Lead Operator @ • Performed various tasks in Fluid bed manufacturing including granulation and Wurster coating • Operated Winchesters “development” scale machine where I worked in a customer facing role which helped develop my communication skills • Operation and troubleshooting of various solid dose manufacturing equipment From November 1992 to January 2001 (8 years 3 months) Chris Abney is skilled in: GMP, Sop, Validation, Pharmaceutical Industry, FDA, Technology Transfer, CAPA, Change Control, Quality System