Brian L. Glass
Columbia,MO
Summary
Results-oriented CMC and small molecule professional with 34 years of experience in analytical and regulatory processes, including 7 to 10 years in project management within the pharmaceutical industry. Demonstrated expertise in authoring Module 2 and Module 3 sections for IND, NDA, ANDA, and BLA submissions, contributing to successful marketing authorizations. Adept at developing quality systems for startup CROs, encompassing change control and Out-Of-Specification (OOS) procedures. Knowledgeable in diverse regulatory pathways such as NDA, ANDA, BLA, and 505(b)(2) for the US and EU markets.
Overview
34
34
years of professional experience
Work History
Senior Consultant
PharmaTech Associates/USP
Heyward, USA
07.2021 - Current
- Consult with pharmaceutical clients on analytical method validations, CMC development for small molecule pharmaceuticals, laboratory compliance, and data integrity, stressing the importance of quality systems maturity and establishing a 'culture of quality,' especially concerning data integrity
- Work with three clients to prepare written responses to FDA 483 observations, EIR, and warning letters regarding laboratory compliance
- Develop briefing materials for Client/FDA Type B and Type C meetings
- Consult on CMC development activities related to drug substance synthesis, impurity identification, E&L studies, and spike/purge/fate study designs
- Author Module 3 and Module 2 sections for NDA/ANDA and DMF submissions and assist in developing regulatory strategies
Staff Scientist II
Eurofins Biopharma Product Testing
01.2019 - 07.2021
- Analytical development/validation for small-molecule and biological drug substances and products
- A significant area of growth was the development and validation of foods as vehicles for the administration of drug products, per the FDA guidance
Senior Chemist
ION Laboratories, Inc.
08.2017 - 06.2018
- Group leader for analytical and quality development and validation activities for over-the-counter (OTC) pharmaceutical preparations
- My challenge was to improve the laboratory compliance to a level that would allow for the manufacturing of OTC pharmaceuticals—point person for implementing GMP compliance and lab quality system upgrades
- Implement USP residual solvent testing for drug substances and herbal raw materials
- Development, implementation, and training of procedures for out-of-specification (OOS)
Senior Scientist
Catalent Pharma Solutions, Inc.
07.2016 - 06.2017
- Analytical development and product development (for early-phase soft gelatin capsules drug products)
- Method development/validation for products requiring GC analysis and HPLC/UPLC
Senior Scientist
CoreRx, Inc.
07.2013 - 06.2016
- Analytical lead and project manager as part of a cross-functional team assisting clients with pharmaceutical development activities for solid, parenteral, suspension, and semi-solid drug products
- Support regulatory activities for Q1/Q2 sameness for parenteral and ophthalmic ANDA submissions
- Analytical risk assessment for method transfer activities
- Formulation development activities, including de-formulation, excipient compatibility studies, etc
- Process validation support for dissolution and assay/related compounds
- Forced degradation studies for drug products
- ANDA development and documentation for ANDA submissions (drug product sections)
- Manage and advise on CMC activities in the early phase of developing drug products and drug substances, including developing feasibility studies/reports, draft methods, validation protocols, and reports
- Development activities include assay/related compounds and dissolution for solid oral dosage forms
Senior Scientist/Team Leader
ABC Laboratories, Inc. (EAG)
07.2007 - 06.2013
- Team leader for extractable/leachable group within the trace analysis and structural chemistry department
- Development and validation of sophisticated LC/MS and GC/MS analytical methods for trace analysis in parenteral and orally inhaled nasal drug products
- Method development and documentation for NDA and ANDA submissions related to extractable/leachable impurities
Quality Control Specialist
GlobeImmune, Inc.
01.2006 - 09.2006
- Develop and implement quality systems for the quality control laboratory
- Developed and validated an automated cell counting method for killed yeast cell vaccines
- Instrument I/O/PQ protocols and reports
Senior Chemist
Upsher-Smith Laboratories, Inc.
01.2002 - 09.2006
- Lead chemist for ANDA and 505(b)(2) submission
- Designed, developed, and implemented forced degradation best practices policy to determine the stability indicating the nature of HPLC methods
- Analytical lead for development projects as part of a multifunctional team
Senior Chemist
MDS Pharma Services, Inc.
12.1998 - 11.2002
- Authored and executed method validation/transfer protocols
- Perform release and stability testing for drug substances and drug products
- Develop and validate analytical methods for cleaning validations
- Managed ICHQ1B photostability testing for confirmatory and forced degradation studies
- Develop protein HPLC methods for special projects
Quality Control Supervisor
Univera Pharmaceuticals, Inc.
06.1996 - 12.1998
- Supervised the quality control laboratory, isolation and identification of impurities and degradation products of new chemical entities
- Developed HPLC/GC methods for natural products extracts
Technical Services Supervisor
Zenith-Goldline Pharmaceuticals, Inc.
01.1991 - 03.1996
- Developed and validated HPLC methods for OTC and ANDA drug products
- Group training for ANDA requirements in the analytical laboratory
- Formulation development for OTC oral solutions
- Development of methods and execution of cleaning validation protocols for manufacturing
Education
B.S - LIFE SCIENCES (ZOOLOGY)
LOUISIANA TECH UNIVERSITY
05.1988
Skills
- Pharmaceutical development
- Quality Assurance Investigations
- CMC Project Management
- Regulatory Writing (NDA, ANDA, BLA Module 2 and 3, Briefing Documents, etc)
- Analytical Chemistry Problem Solving
- Formulation Development
- Communications to the FDA (meeting request, 483, and warning letter remediation)
Publications
- ICH & USP : Implementing A QbD Analytical Framework, https://www.bioprocessonline.com/doc/ich-usp-implementing-a-qbd-analytical-framework-0001
- Assessing pDNA Purity for Cell & Gene Therapies, https://www.cellandgene.com/doc/assessing-pdna-purity-for-cell-gene-therapies-0001
- New ICH Q14 Guidance Applies QbD to Analytical Procedures, https://www.biosimilardevelopment.com/doc/new-ich-q-guidance-applies-qbd-to-analytical-procedures-0001
Timeline
Senior Consultant
PharmaTech Associates/USP
07.2021 - Current
Staff Scientist II
Eurofins Biopharma Product Testing
01.2019 - 07.2021
Senior Chemist
ION Laboratories, Inc.
08.2017 - 06.2018
Senior Scientist
Catalent Pharma Solutions, Inc.
07.2016 - 06.2017
Senior Scientist
CoreRx, Inc.
07.2013 - 06.2016
Senior Scientist/Team Leader
ABC Laboratories, Inc. (EAG)
07.2007 - 06.2013
Quality Control Specialist
GlobeImmune, Inc.
01.2006 - 09.2006
Senior Chemist
Upsher-Smith Laboratories, Inc.
01.2002 - 09.2006
Senior Chemist
MDS Pharma Services, Inc.
12.1998 - 11.2002
Quality Control Supervisor
Univera Pharmaceuticals, Inc.
06.1996 - 12.1998
Technical Services Supervisor
Zenith-Goldline Pharmaceuticals, Inc.
01.1991 - 03.1996
B.S - LIFE SCIENCES (ZOOLOGY)
LOUISIANA TECH UNIVERSITY
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