Bridgewater Chapter Upcoming Events Join PCCI

Member Profiles

 

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.

 

 

 

 

 

Contact Info:

Company:
Spangler Consulting LLC
2241 Morse Avenue

Scotch Plains, NJ 07076

Tel: (908) 232-3117

Email: mspangler@spanglerconsultingllc.com
Web: spanglerconsultingllc.com

 

Good Company! Good Drink! Good Food! Good Program! Good Fun!

 

Site Navigation

HOME  |  ABOUT PCCI  |   DIRECTIONS  |   BRIDGEWATER DIRECTIONS  |   JOIN US  |   BOARD MEMBERS  |   AFFILIATES  |  NEXT MEETING  |  ARCHIVES

PROFILES CALENDAR OF EVENTS  |  BRIDGEWATER CHAPTER  |  FEEDBACK / COMMENTS  |   CONTACT US

Pharmaceutical Consulting Consortium International, Inc.,

info@rxpcci.com or (610) 296-8086

Meetings Held at Embassy Suites - Valley Forge

888 Chesterbrook Blvd, Chesterbrook, Pennsylvania 19087

All content on this website is copyrighted and should not be reproduced without the consent of PCCI.

© Copyright 2016-2018

 

 

Tat Communication Inc