Quality Control R D

Professional Summary

Dedicated and results-driven Senior Scientist with over 20 years of experience in R&D, QA/QC specializing in analytical chemistry. Proven expertise in developing and validating analytical methods, driving innovation, and leading cross-functional teams. Strong background in analytical method development (chromatographic), quality control, and regulatory compliance with a proven track record of successful project delivery and solving complex problems.

Core Competencies

Analytical Method Development and Validation (FDA regulatory submission)

Process Improvement: Lean Six Sigma (Green Belt)

Manual Testing & Test Case Development

Process Validation: protocol development Manufacturing processes/equipment

Auditor- Lead Assessor ANAB and A2LA, FDA 483

Cleaning Validation, Environmental Monitoring

Facilities; Gowning, Sanitation, Utilities

OOS, CAPA, Change Control

Quality Control & Assurance

Qualification: IQ OQ PQ

Regulatory Compliance (FDA, EMA, ISO)

Project Management

Data Analysis & Interpretation

Cross-Functional Team Leadership

Technical Documentation

Instrumentation Expertise (TOC, KF, HPLC-UV, GCMS(MS), LCMSMS, LC-QTOF)

Professional Experience

Senior Scientist, Analytical R&D

Fresenius Medical Care, Ogden UT (Contractor)

05/2023 – Present

Led the development and validation of analytical methods for cGMP Initiative for RD analytical laboratory for Nitrosamines by LCMSMS and GCMSMS, Total Organic Carbon water testing, and Extractable Leachables special projects, ensuring compliance with regulatory standards.

Collaborate with cross-functional teams, such as engineering and quality control, to support product development (Testing methodologies and in-home Medical Devices) from the initial concept through final design/product release.

Conducted stability studies and robustness studies on various matrices (PD Solutions)

Developed analytical method (LC-QTOF and GC-QTOF) for prevention of product recall – extractable/leachable with tight timelines, with qualitative and quantitative requirements.

Performed routine calibration, maintenance, and troubleshooting of analytical instrumentation including reporting of all documentation and wrote all protocols for Preventative Maintenance.

Scientist, Analytical Chemistry

Longboard Scientific Consulting (Owner)

05, 2017 – Present

Developed and validated robust analytical methods for botanicals, pharmaceuticals, and food/ag, meeting regulatory and compliance requirements.

Facility Design and Workflow Optimization (several projects) increasing process efficiency in clinical diagnostics and botanical testing with a sample throughput of over 5000 samples per week- chemistry and microbiological testing with a 12-week timeline.

Conducted several method transfers, ensuring seamless integration and compliance with Test Methods including new product/process QS-21 vaccine adjuvant.

Performed instrument qualification and test case development routine maintenance and analytical instrumentation (HPLC-UV-ELSD, TOC, LCMSMS).

Development of state (Board of Pharmacy- OH) testing regulatory framework for botanicals.

Job History

Thermo Fisher Scientific. San Diego, CA

06/2010 to 02/2013.

Applications Manager Chromatography Consumables North America (8 direct reports) Clinical and Pharmaceuticals Market LCD- Chromatography and Sample Preparation Products.

Innovative Pharmaceuticals/Amneal Pharmaceuticals

QC Director- Manufacturing and Testing Transdermal Technology (Patent holder) 08/2008 to 06/2011. Project Lead on Facility decommission and transfer CA to NJ.

Neurocrine Biosciences

Scientist I

Preclinical QToF Operator- Metabolism (56418 Drug Candidate, now approved) 02/2007 to 03/2008

AIG

Risk Manager (Environmental) 03/2006 to 03/2007

Waters Corporation

Technical Support Specialist (Drug Discovery/Pharma markets) 02/2002 to 03/2006

Support Business Development and Sales: High-throughput purification developed and supported HPLC purification gram scale. Los Angeles Top Sales Performance 2003, 2004.

Education

Ph.D. in Analytical Chemistry specializing in polymers

University of Akron, Akron OH

B.A. in Chemistry

Goucher College, Baltimore MD

Certifications

C (ASCP) CM

CLS - Hawaii

Green Belt (Six Sigma) in progress

Project Management (Google)

Professional Affiliations

Member, ASTM

Member, ISPE

References: Available upon request.

Contact this candidate