Menu
Log in
Forgot password

   CHEMICAL CONSULTANTS NETWORK

Log in

Michael Spangler

Spangler Consulting LLC

 

Member profile details

Photo
First name
Michael
Last name
Spangler
Organization
Spangler Consulting LLC
Logo
 

Contact information

City
Martinsville
State or Province
New Jersey
Zip Code
08836
Country
United States
Phone
908.461.8365
Phone (Alternate)
908.232.3117
 

Specialties and Services

Fields of Expertise
  • Analytical
  • High Performance Liquid Chromatography
  • Pharmaceutical
  • Quality
  • Regulatory Affairs
  • Technology Transfer
  • Validation
Other Fields of Expertise
Quality Systems
GMP compliance
Quality Management Systems (QMS)
Data Integrity Investigations
Out of Specification (OOS) Investigations
Deviations
Change Control
Corrective Action Preventative Action (CAPA)
Summary
Global consulting services focus on:
• Developing, assessing, and remediating QMS programs and individual Quality Systems
• Accelerating the approvable CMC development of drug substances, drug products, and medical devices
Services
Michael Spangler advises Pharma leadership and Quality organizations, providing review, counterpoint, and an independent perspective on scientific, GMP compliance, and human challenges.
• Upgrade Quality Systems and improve GMP compliance
• Author and review protocols and reports, CMC module 2 and 3 content, and regulatory responses
• Advise on CMC product, analytical method, and process development
• Focus and simplify rational specification development, and justifications
• Provide hands-on regulatory and CMC project management, and QA Interim Management Controls
• Drive investigations, deviations, Change Controls, and CAPAs to documented completion
• Author SOPs and training materials, coach and mentor staff
• Lead CRO projects and Technology Transfers, conduct vendor audits, and support Due Diligence audits
• Support inspection readiness, provide inspection behavior training, and build the back room team
 

Additional Information

Experience
CONSULTING EXPERIENCE

Small Immunotherapy Pharma Company
• Built a GMP Quality Management System (QMS) program. Designed a Supplier Management program, Authored 20+ Quality SOPs.

Small Biotech Company
• Advised senior management on CMC (chemistry, manufacturing, and control) strategies. Reviewed CMC protocols, reports, laboratory investigations and deviations. Critiqued module 2 and 3 regulatory content.

Mid-sized Biotech Company
• Assessed clinical and non-clinical Bioanalytical studies and supporting validations for remediation.
• Performed data corrections, QC reviews, data integrity investigations, and QA approvals.
• Conducted contract lab site audits.
• Authored Bioanalytical study reports and amendments, SOPs, Quality protocols, risk assessments, position papers, QA investigations, deviations, and CAPAs (Corrective Action Preventative Action).
• Led a group of eight GLP consultants supporting DMPK (Drug Metabolism and Pharmacokinetics).
• Assessed and planned the remediation of the QMS, management responsibilities.

Small Contract Analytical Laboratory
• Reviewed and edited GMP validation protocols and reports. Advised executive management during and after business development meetings with potential new customers.

Potential Buyer of a Mid-sized Pharmaceutical Company
• Due Diligence audit of GMP laboratory operations and controlled substances practices, estimated analytical and Quality workload capacity, and evaluated laboratory management. Partnered closely with legal team auditors.

Large Excipient Manufacturer
• Mapped an approvable CMC development strategy and identified potential development pitfalls.

External Services Organization of a Large Pharma Company
• Assessed GMP analytical, stability, cleaning, manufacturing process, and packaging validations, annual product reports, post-approval regulatory filings, and remediated the batch release QA process.
• Successfully prepared for a compliance inspection, hosted inspectors, and led Lessons Learned meetings.

Large Generic Pharma Client, Manufacturing Plant
• Assessed FDA inspection readiness of the stability program and confirmed stability trends. Advised on manufacturing and laboratory OOS (out of specification) investigations. Cleared backlogged deviations, calibrations, and change controls.

Three additional consulting clients (2009-2012) assessing Annual Reports, validations, stability programs, complaints, Adverse Events, and labeling, drafting SOPs, driving deviations, change controls, and CAPAs to documented completion, QA approvals, guiding OOS investigations, and critiquing CMC submissions.
More Experience
EMPLOYMENT HISTORY

Schering-Plough Research Institute
Senior Principal Scientist, Sep 1989 – Mar 2009
• Held analytical research and development positions from Associate Scientist, to Scientist, Scientist II, Senior Scientist, Associate Principal Scientist, Principal Scientist, and to Senior Principal Scientist.
• Led large global analytical teams supporting API and drug product development programs (toxicological drug substance release through post-NDA support). Directly supervised and developed groups of up to 9 scientists in both research and GMP environments. Managed technology transfers and CRO relationships. Participated in Consent Decree remediations.
• 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. Key CMC author for regulatory submissions.
• Analytical Team Leader for the Vorapaxar program from Phase I to Phase III. Directed analytical teams for the reformulation of Temodar/Temodal capsules. Led the analytical program for a priority CNS compound from pre-Tox to Phase I. Authored CMC sections and regulatory documents using the CTD format (common technical document).
• Authored approved CMC content for Elocon Cream, Claritin-D 12 Hour Tablets, Azium Powder and Solution, Claritin Syrup, Clarinex-D 24 Hour Tablets, Temodar Capsules, and Vorapaxar Tablets. Proposed and justified specifications, responded to FDA and Health Authority regulatory questions.

Purdue Frederick Research Center
Research Scientist, 1987 to 1989

Warner-Lambert / Parke-Davis
Associate Analyst, 1984 to 1987
Education
MS, INDUSTRIAL PHARMACY – Long Island University, 1996
College of Pharmacy, University Plaza, Brooklyn, NY, research and published thesis

BS, CHEMISTRY – Juniata College, 1983
Huntingdon, Pennsylvania, ACS accredited, with senior research
Publications
• A Blueprint for Outsourcing Audits of Approved Validations, FDA-NJPQCA Joint Quality Conference, (New Jersey Pharmaceutical Quality Control Association), East Hanover, NJ, May 23, 2017.
• Pharma GMP Validation, New Jersey Pharmaceutical Quality Control Association Quality Certification Course Instructor, East Hanover, NJ, May 21, 2014.
• To Validate or Not To Validate, A Daily Question for the Pharmaceutical Scientist, New Jersey Pharmaceutical Quality Control Association, Kenilworth, NJ, January 15, 2013.
• Analytical Innovations Focused on Petrolatum and Prototype Semisolid Formulations, Laboratory for Drug Delivery Seminar, New Jersey Center for Biomedical Materials, Rutgers University, New Brunswick, NJ, June 21, 2009.
• A Validated, Stability-Indicating Method for the Assay of Dexamethasone in Drug Substance and Drug Product Analyses, and the Assay of Preservatives in Drug Product, M.D. Spangler and E.A. Mularz, Chromatographia, 54 (5/6), 329-334, 2001.
• A Novel Percolation Method for Determining Solubilities of Pharmaceutical Agents in Semisolid Vehicles, M.D. Spangler and D. Harris, Pharmaceutical Development and Technology, 4 (4), 545-552, 1999.
• Eight Chromatographic Techniques in Support of the Development of an Antipsoriatic Drug, SCH 40120
- ACS Middle Atlantic Regional Meeting, Fairleigh Dickinson University, NJ, May 1999.
- Chromatography Forum of Delaware Valley, Philadelphia, PA, December 1998.
- New England Chromatography Council, Hartford, CN, March 1996.
• In Vitro Metabolism of 10-(3-Chlorophenyl)-6, 8, 9, 10-tetrahydrobeno [b] [1, 8] napthyridin–5 (7H)-one, A Topical Antipsoriatic Agent. Use of Precision-Cut Rat, Dog, Monkey and Human Liver Slices, and Chemical Synthesis of Metabolites, Shmuel Zbaida et. al., Biopharmaceutics & Drug Disposition, 19: 315 332, 1998.
• Oil Migration: A Performance Test of Petrolatum, M.D. Spangler, T.D. Miles, and E.A. Mularz, Pharmaceutical Technology, 21 (9), 86-99, 1997.
• Hydroxylation of SCH40120 a Polycyclic N-aryl Pyridone by Cunninghamella Echinulata, C.W. Heinzelman, R.J. Friary, M.D. Spangler, D.R. Dodds, and R.A. Roehl, American Society for Microbiology, Miami Beach, FL, May 1997.
• Enantiomerization of an Atropisomeric Drug, R.J. Friary, M.D. Spangler, R. Osterman, L. Schulman, and J.H. Schwerdt, Chirality 8 (5), 364-371, 1996.
• Quantitation of the Organic Solvent Extractables (OSE) of Petrolatum and Analysis by Capillary Gas Chromatography, M.D. Spangler and M.B. Sidhom, Journal of Pharmaceutical and Biomedical Analysis, 15 (1), 139-143, 1996.
• Organic Solvent Extractables of Petrolatum, M.D. Spangler, M.B. Sidhom, E.A. Mularz, and F.M. Plakogiannis, American Association of Pharmaceutical Scientists, Miami, FL, November 1995.
More Publications
• Biotransformations of a Polycyclic N-aryl Pyridone by Cunninghamella Echinulata, C.W. Heinzelman, R.J. Friary, M.D. Spangler, and R.A. Roehl, Society for Industrial Microbiology, San Jose, CA, August 1995.
• In Vitro Metabolism of SCH40120, a Topical Leukotriene Inhibitor, in Animals and Man, S. Zbaida, et. al., European Conference on Specificity and Variability in Drug Metabolism, Besancon, France, May 1995.
• Computers in Regulatory Affairs: An Update on Progress, M.M. Rumore, M.D. Spangler, and A.A. Albano, Regulatory Affairs, 6, 87-96, 1994.
• Isocratic Reversed Phase HPLC Analysis of a Pharmaceutical Cream, M.D. Spangler, Supelco Reporter, 13 (2), 12, 1994.
• An HPLC Method for a Pharmaceutical Cream to Assay the Preservative, Multiple Actives, and Related Products, M.D. Spangler, Eastern Analytical Symposium, Somerset, NJ, November 1992.
• Finding a Bleachable Fluorescein Dye Solution, M.D. Spangler, Intercollegiate Student Chemist Convention, Temple University, Philadelphia, PA, April 1983.
Miscellaneous
Pharmaceutical Consulting Consortium International profile (PCCI)
http://www.rxpcci.com/profiles/spangler-m.htm

LinkedIn profile
https://www.linkedin.com/in/michael-spangler-0049867
The ideas, advice and positions expressed by individual members of the Chemical Consultants Network are the member's own and not the responsibility of CCN or its sponsors, the American Chemical Society and the American Institute of Chemical Engineers.

© 2017 Chemical Consultants Network 

Chemical Consultants Nework is jointly supported by AlChE and ACS

Powered by Wild Apricot Membership Software