John Kandl

John joined BioTechLogic in 2008 with a focus on contract manufacturing management, process development, and validation activities. John has over 25 years of experience in the biopharmaceutical industry. Prior to joining BTL he held Quality Assurance positions at Exelixis and Tercica, Inc where he maintained oversight of the contract manufacturing for numerous APIs and drug products, developed corporate quality systems, validation programs, and regulatory submissions. Prior to this John was a Project Engineer with SAVIS Inc., an engineering consulting firm for the pharmaceutical/biotechnology industry. At SAVIS, John led numerous analytical, equipment, computer, cleaning, and process validation projects.

Since joining BioTechLogic, John has provided technical operations and quality support services for numerous clients across multiple product types.  Activities include implementation of process characterization and validation programs, PAI readiness and quality system improvement projects, development of Cleaning Validation programs, and cross contamination risk assessments.  Additional projects included the generation of process development protocols/reports, execution of PPQ and supporting studies, design of process simulation testing programs, development of lot release, deviation, change management programs, and implementation of risk based approaches to quality system procedures.

John has participated in multiple facility and quality system improvement projects for new facility startups, to aid in commercial readiness, and resolutions of findings after inspections.  Remediation activities included oversite of facility/utility requalification, revision of procedures, development of engineering and maintenance management programs, review and approval of critical utilities, equipment qualification, cleaning validation, and process validation projects.  Facility startup activities include generation of quality system procedures, development of asset management, maintenance and calibration programs, design and implementation of equipment commissioning and qualification programs and procedures.

Regulatory support activities include preparation of regulatory submission documentation for Biologics, Vaccines, and Combination Products for INDs, ANDA, BLA, NDA, MAA, and PAS’s.

• Stage 1 and Stage 2 Process Validation activities
• Quality Systems remediation and Improvement projects
• Facility Gap Assessments and implementation of Quality Risk Management programs
• Inspection Readiness Preparation
• CDMO Selection and Vendor Management
• Quality Assurance Support Services

University of Missouri
B.S. in Chemical Engineering