Areas of expertise include: Quality Assurance, Quality Control, Regulatory Affairs, GMP/GLP/GCP Global Compliance, Manufacturing Operations (both clinical and commercial), Pharmaceutical Engineering, GMP Facility Design and Start-up, and Validation.
Across Tim Mitchell’s 40+ year career in the biopharmaceutical industry, he has helped successfully bring over 20 drugs to market and had direct oversight and support of 12 new GMP aseptic manufacturing facilities worth over $1.3 billion in total constructed/installed costs; all of them being sterile/aseptic manufacturing facilities. He has been a trusted consultant to some of the industry’s largest manufacturers and throughout the years has consulted with Wyeth, Bristol-Meyer-Squibb, Eli Lilly & Company, Amgen, and Roche.
• Extensive experience with human gene and cell therapy, human stem cell therapy, immunobiologics, and recombinant large molecule technologies, focusing substantially in the areas of quality assurance and control, regulatory affairs, global compliance, process development, manufacturing operations, validation, aseptic facility engineering, and site management.
• Most recent experience has been within the Mesenchymal stem cell therapy, AAV gene therapy, and (CAR-T) cell therapy development space. Majority of career in direct support of new biologic product development and licensing, from pre-clincial IND development and submission, through each phase of clinical study and clinical process development (GCP/GLP/GMP), through final product BLA filing and operational transition into commercialization.
• In-depth knowledge of aseptic and sterile product manufacturing operations. Primary career focus has been associated with gene and cell therapy, biological, and drug parenteral products supporting global compliance assessment and management, through facility design and operational GMP control, finished product manufacturing, labeling, and packaging.
• Balanced career spent within quality, regulatory, operations, and global compliance, with the majority of those years in management roles overseeing both project activities and operational departments in support of CMC development, clinical, and commercial GMP manufacturing operations.
• Direct face-to-face interaction with FDA (CDER, CBER, ORA), European Union (EMEA, MHRA), Japan (PMDA), Health Canada, Australian (TGA), and Chinese (CFDA) regulatory authorities regarding IND, BLA, and NDA submissions, pre-approval inspections (PAI’s), post-approval (commercialization) GMP inspections, follow-up written communications addressing compliance questions to existing operations, along with new facility design and validation presentations to agency representatives prior to construction.
• Thorough knowledge associated with the establishment and management of CMC regulatory documentation and operational and quality/compliance programs and systems in the support of these new manufacturing facilities, built for both large-scale commercial and pilot-scale clinical production of sterile human cells, biologics, and protein-based pharmaceuticals in compliance with global GMP regulations.
PURDUE UNIVERSITY:
Master of Science 1984, Genetic Biology; Bachelor of Science 1983, Biochemistry
MAJOR COMPANIES I HAVE WORKED FOR:
Eli Lilly & Company (14 years)
Adventis Behring (4 years)
Celgene Corporation (4 years)
NABI Biopharmaceuticals (4 years)
LinkedIn Profile: www.linkedin.com/in/tim-mitchell-06259564
AJ Kirchoff has been a practicing registered pharmacist for 40+ years, working with many of the top companies in the United States since graduating from Purdue University. Throughout her career, she has consulted with various aseptic GMP compounding pharmacies, pharmaceutical GMP manufacturing companies, and GLP laboratories. Her scope of regulatory compliance oversight spans from DEA (controlled substance regulations), state drug dispensation regulations, to US FDA GMP manufacturing regulations. Prior to becoming a registered pharmacist, AJ worked for Eli Lilly & Company as a Quality Control chemist.
• Most recent experience has been working with various biotech clients in both the early and later stages of clinical development to establish “phase appropriate” quality systems to meet the needs of GMP controls applicable. The overall objective has been to initiate a quality system that is effective at GMP controls, yet scalable as the client nears product commercialization.
• Served as the interim Document Control Coordinator for clients prior to their becoming fully staffed. AJ created standards for various document structure, review, and approval, while maintaining accurate access to those effective SOPs. She acted as a member of the client’s staff under contract.
• Assessed multiple GMP Quality Systems for compliant adherence of the effective SOPs during normal site operations. All SOPs must generate documented evidence of proper execution.
• Directly driven organizational effectiveness by utilizing available personnel to meet operational needs, based on both specific campaign projects and regular business operations. Scheduling, training, hiring, and evaluating are among the management tools that she has become proficient with. AJ has been extensively involved with the organization and execution of Covid-19 immunization clinics.
• Over the span of her career as a Pharmacist-In-Charge (PIC), AJ has led many regulatory inspections of operating pharmacies. Such agencies as State Boards of Pharmacy, Internal Auditors, DEA Agents, Local Law Enforcement, and Loss Prevention are among such agencies that she has interfaced with and followed-up on negative observations that may have been noted.
• The initial period of AJ’s professional career was spent working for Eli Lilly and Company as a Quality Control laboratory chemist carrying out various test methods on both final and interim commercial product being manufactured at the site. She often would train new analysts to the department upon hire.
• During AJ’s career as a Registered Pharmacist, she managed small-scale drug compounding operations. Such operations would include the manufacture of oral, topical, vaginal, and rectal dosage forms to individualized specific patient requirements. In addition, aseptic finish-fill operations constituted much of her time overseeing sterile hormone injection forms and sterile ophthalmic dosage forms. As the Pharmacist, AJ served as the Quality Assurance oversight throughout manufacturing and provided final product release approval.
• Among examples of continuous improvement opportunities that AJ worked, there were multiple occasions she led the implementation of automatic drug dispensation robotics in the pharmacies. She would work directly with the companies installing and configuring the units. She provided direction on their most efficient use for each particular location. AJ would become first trained on the operation of the robotic units, working to identify and alleviate initial operational glitches. She later would train staff members of pharmacy to carryout normal daily use. The implementation of such automation created significant drug dispensation efficiency by reducing time and personnel required.
PURDUE UNIVERSITY:
Doctor of Pharmacy (Pharm. D.) 1986
REGISTERED PHARMACIST IN:
Indiana, Missouri, Arkansas, Arizona, South Carolina, Virginia
LinkedIn Profile:
www.linkedin.com/in/aj-kirchoff-8534bb218
