|
Michael Spangler
Analytical and CMC Consultant
Michael Spangler is the owner and Principal Consultant at SPANGLER CONSULTING LLC (www.spanglerconsultingllc.com). Michael provides global consulting services to accelerate the Analytical, specification, and CMC development (Chemistry, Manufacturing, and Control) of pharmaceutical drug substances and drug products.
Spangler Consulting LLC Services:
design and implement fit-for-purpose Analytical development and Stability programs
develop API (active pharmaceutical ingredient) and drug product specifications
author protocols, technical reports, and approvable CMC content
partner with your synthetic and formulation development teams
effectively manage your CRO relationships (contract research organizations)
provide your business the creativity of an articulate scientific leader, who has the ability to communicate clearly to non-scientific business partners, across cultures and around the globe
Before consulting, Michael was an Analytical Team Leader and manager at the Schering-Plough Research Institute. He was responsible for analytical programs from pre-tox through global regulatory approvals. He proposed broad analytical strategies and executed specific tactical plans for drug substance and drug product analysis, excipients, equipment cleaning, dissolution testing, physical-chemical analysis, and microbiological analytical inputs.
At Schering Michael developed, validated, and transferred GMP release and stability test methods and specifications. He was a CMC author contributing to several high-profile drug approvals. He managed CROs (contract research organizations), and supported Consent Decree remediation and Due Diligence programs. He also has a research interest in the performance testing of excipients and drug products, especially creams and ointments.
Michael’s early training was as an HPLC method development and automation scientist. He is well published, has presented, and has invented several novel testing techniques. He earned a BS in Chemistry and a MS in Industrial Pharmacy.
|
