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Jessica Morgan

@jessicamorgan1

Quality Control Analytical Manager at Matica biotechnology, implementing LIMS and leading analytical method transfers, investigations, and GMP compliance.

United States

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At Matica biotechnology, I oversee QC laboratory operations, analytical testing, and compliance. I lead method transfers between Analytical Development and Quality Control, and contributed to implementing and validating the LIMS.

Previously, as Quality Control Analytical Supervisor at Matica biotechnology, I established the Analytical sub-department and directed QC laboratory setup for GMP operations. I also partnered with Information Technology on site-wide LIMS implementation and developed QC Analytical training programs.

Earlier, I performed analytical testing and supported laboratory improvements at Tolmar and PharmAssist Inc. At PharmAssist Inc., I developed an Ion Chromatography assay method under ICH and GMP guidelines and supported method qualifications for client BLA submissions. I hold a B.S. in Pharmacology and Toxicology and am a Certified Quality Auditor.

Experience

Work history, roles, and key accomplishments

Current

Quality Control Analytical Manager

Current

Matica Biotechnology

Jan 2023 - Present (3 years 9 months)

Accountable for all QC laboratory operations, including analytical testing, staff management, and compliance oversight. Lead analytical method transfers and serve as primary liaison with clients, vendors, and suppliers.

Quality Control Analytical Testing Staff Management Compliance ICH Guidelines Method Transfer LIMS Data Integrity SOPs CAPA OOS OOT Audit Budget Management Equipment Qualification EH&S

Quality Control Analytical Supervisor

Matica Biotechnology

Jan 2022 - Dec 2023 (1 year 11 months)

Established the Analytical sub-department within the Quality Control organization, defining structure, workflows, and resource needs. Supervised and led QC Analytical staff, including hiring, training, mentoring, and performance management.

Quality Control Team Leadership LIMS Implementation GMP Regulatory Compliance SOPs URS SIA Training Programs CAPA Cross Functional Collaboration

QC Chemist III

Tolmar

Jan 2020 - Dec 2022 (2 years 11 months)

Performed routine analytical testing for dermatology and injectable product lines, including finished product, stability, bulk, and in-process samples. Served on laboratory improvement teams to enhance morale and streamline workflows.

HPLC LIMS Veeva CA Endevor Chromeleon Viscometer Rheometer CAPA RCA GMP Analytical Testing Data Integrity Training

Analytical Chemist II

PharmAssist Inc.

Jan 2017 - Dec 2020 (3 years 11 months)

Performed GMP-regulated analytical testing for multiple clients, including stability, release, and expedited samples. Supported root cause investigations and contributed to CAPA implementation.

GMP Analytical Testing Stability Testing Release Testing SOPs CAPA LIMS Method Development Ion Chromatography Data Integrity Training

Research Assistant, Method Development and Analytical Services

Alvogen

Jan 2015 - Dec 2017 (2 years 11 months)

Performed compendial testing and wet chemistry testing based on USP and EP. Assisted in the development of a tamper deterrent FTF product and utilized SAP for Controlled Substance inventory.

USP HPLC FTIR UV Vis Dissolution Content Uniformity Blend Uniformity SAP Wet Chemistry

Contractor

Pfizer

Jan 2013 - Dec 2014 (1 year 11 months)

Provided innovative insights for the project theater and assigned potential key opinion leaders. Consolidated and encoded competitor product information into the Pfizer database.

Market Research Data Analysis Database Management Project Coordination

Gastrointestinal Global Franchise Medical Intern

Pfizer

Jan 2013 - Dec 2013 (11 months)

Conducted extensive research on competitor products and contributed to a major Rx to OTC switch project. Supported data analysis and claims review for regulatory submissions.

Research Data Analysis Clinical Trials Regulatory Affairs Pharmacology Toxicology

Education

Degrees, certifications, and relevant coursework

American Society for Quality

Certified Quality Auditor, Quality Auditing

Certified Quality Auditor issued in October 2025, valid through December 2029.

University at Buffalo, The State University of New York

Bachelor of Science, Pharmacology and Toxicology

Activities and societies: Research Assistant, Department of Pharmacology and Toxicology

Bachelor of Science in Pharmacology and Toxicology. Served as a Research Assistant in the Department of Pharmacology and Toxicology, supporting a study on chlorpyrifos exposure in adolescent agricultural workers.