Jessica Hendricks
Quality Control Director
- Role
- Director of Quality Control at axogen
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Jessica Hendricks
Analytical chemist dedicated to improving the integrity of laboratory data and building a high performing analytical team. I have a strong attention to detail and enthusiasm for building processes. 10+ years experience in U/HPLC-MS/MS and quality control including method validation, proficiency testing, quality control testing, and laboratory management. High level understanding and execution of GLP, CAP/CLIA, and GMP regulated studies. Additional laboratory experience in flow cytometry, confocal microscopy, and protein expression. Currently overseeing the Quality Control department for release testing, raw materials, and stability of Axogen’s flagship product, Avance. Support regulatory filings, investigations, method optimization, and process workflows to reduce cost and release of drug product.Quality Control Site Head for In-Process testing, Release, Stability, Microbiology, and systems for (GMP) manufacturing of oligonucleotides in pharmaceutical development. Responsible for on-time delivery of reports/COAs, quality systems, investigation and deviation closure. Served as Quality Control team lead for Biomarker Services overseeing data for ligand binding assays, liquid chromatography mass spectrometry, flow cytometry, and molecular genomics across two laboratory environments, bridging Bioanalytical Labs and Global Central Labs in exploratory and Clinical Phase trials, establishing GLP compliance at GCL.I successfully developed a first and second tier screening method for the detection of adenosine deaminase severe combined immunodeficiency (ADA-SCID) in addition to quality control material in dried blood spots associated with the disorder. Served as project lead for high precision amino acid and acylcarnitine proficiency testing material, and 1st and 2nd tier screening material for method validation. I am experienced with the ISO process, including document control, reviewing/revising/writing SOPs, deviations and CAPA system, with experience working in ISO-17043 and ISO-15189 accredited laboratories. I have a vast knowledge and experience in scientific and FDA supported report, plan, and method writing for qualifications, validations, and analytical studies. In addition to this, I am an active community member dedicated to merging science and art, in hopes that the collaboration will serve as an increased means of exposure to science for young people.
Experience
Director of Quality Control
Oct 2025 — Present
Oversee the team responsible for testing, productivity, and quality events in the Quality Control Department, specific to microbial, analytical, and histology analysis. Cross-functional support, working across departments to drive robust training and lean processes to support Avance, Axogen’s flagship product, targeting peripheral nerve regeneration.
Education
Tennessee Technological University
Master's Degree, Chemistry
University of Florida
Bachelor's Degree, Microbiology and Cell Sciences
Skills
- Teaching
- Data Analysis
- Management
- Analytical Chemistry
- Confocal Microscopy
- Presentation Skills
- Immunostaining
- Molecular Biology
- Fluorescence Microscopy
- Lecturing
- Public Speaking
- Chromatography
- Research
- Author
- Mass Spectrometry
- Science
- Microsoft Office
- Liquid Chromatography-Mass Spectrometry (Lc-Ms)
- Environmental Awareness
- Method Development
- Laboratory
- Analytical Method Validation
- Chemistry
- Environmental Policy
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