Danielle Heyrman Email & Phone Number

Chicago, Il, Us

Melrose Park, Illinois, United States

Method development targeting HPLC analysis, protein characterization, and bioassays for biologic generics

Chicago, Il

• Potency determination of release and stability samples for two biosimilars using validated cell methods• Testing of samples for ELISA, SDS-PAGE, UV-Vis, pH, appearance, cell-based potency assays, routine mammalian cell culture, etc.• Lead coordinator for forced degradation studies of biosimilar – thermal, oxidation, pH, photooxidation stress• Reference standard coordinator for QC lab – RS performance trending for potency methods• Author of protocols, SOPs, deviations, investigations, change controls, and Certificate of analysis• Liaison for QC to Engineering for equipment maintenance, movement, and IOQ-PQ• FDA PAI inspection experience – questioned by agents to defend methods • Trainer for QC methods

Greater Chicago Area

• Participated and defended cell-based potency assay, UV-Vis, ELISA, DSC to FDA during PAI• Assisted in authoring of analytical sections for BLA• Potency determination of release and stability samples for two biosimilars using validated cell methods• Performed receptor binding ELISA and free thiol assay for protein characterization tests• Instrument and software qualification of Molecular Device plate readers utilizing SoftmaxPro• Authoring of protocols, test methods, validations, SOP, deviations, investigations, CAPA, and change controls• Testing of samples for DSC, UV-Vis, pH, appearance, host cell protein ELISA, cell-based potency assays, free thiol determination

Greater Chicago Area

• Mammalian cell culture of M-NFS-60 cell lines utilizing aseptic technique – biological safety cabinets• Potency determination of release and stability samples for two biosimilars • Cell based bioassay method development per USP guidelines for potency determination of biosimilars • Protein concentration determination of in process manufacturing and prepared samples• Differential scanning calorimetry for thermal melting point determination of biosimilars• Endotoxin level determination of in process manufacturing samples and final product

• Bioassay method development per USP guidelines for anticoagulants – manual methods using 96-well plates along with automated ACL TOP systems• Validation of developed methods – Precision, Accuracy, Specificity, Linearity, and Range• Forced and accelerated degradation studies of crude API – effect on final concentrations• On-site safety officer – EPA and internal audits, OSHA compliance, RCRA and DOT certified for hazardous chemical management and transportation, ability to sign waste manifests, and SDS management• Usage of SEC-MALS for molecular weight distribution determination of in process reactions• Endotoxin level determination of in process and final product API• Bioburden testing using R2A and Sabouraud Dextrose Agar media cassettes – Milliflex system• Maintenance and calibration of laboratory analytical balances and Elga water system

Lemont, Il

• Cloning and purification of solute binding proteins of ABC transporters from Rhodopseudomonas palustris• Biophysical characterization of proteins by ITC, Biolayer Interferometry (FortéBio Octet), and fluorescence• Cloning techniques – primer design, PCR, restriction digests of plasmids, ligation independent cloning (LIC), BL21 cell lines, transformation, DNA agarose gels, safe ethidum bromide handling experience• Cell culture techniques – preparation and streaking of colonies on agar antibiotic plates, 2XYT small scale and large scale cell cultures, IPTG induction• Determination of expression and solubility levels of cloned targets by reducing SDS-PAGE • Preparation of cell lysate by chemical, temperature and sonication • 6xHis protein purification using Ni-NTA bench top columns or use of AKTA purification system

• Quality control of in-process reactions and final product by ASTM methods• Calibration, maintenance, and troubleshooting of SRI gas chromatograph• Usage of Karl-Fisher and Free-fatty acid automated titrators, flash point determination, and fixed wavelength UV-Vis spectroscopy• Research projects for in-process improvements• Responsible for SOP development, laboratory inventory, supplies, and chemical ordering

• Developed micro immunofluorescence assay utilizing intrinsic tryptophan fluorescence• Performed protein chromatography techniques including ion exchange, affinity, and size exclusion• Probed protein identity and function by SDS-PAGE, ELISA, and immunofluorescence assays• DNA analysis per PCR and gel electrophoresis• Crystallization of small molecules by slow evaporation, liquid diffusion, and vapor diffusion• Spectroscopic analysis by use of FT-IR, Raman, 1H and 13C NMR techniques• Computational optimization and spectroscopic predictions of small molecules by use of Gaussian

Kalamazoo, Michigan Area

• Analysis of raw materials, in-process reaction samples, and trace analysis by gas chromatography• GMP work environment – strong documentation skills• Maintenance, calibration, and troubleshooting of automated dual channel HP gas chromatographs

Master Of Science (M.S.), Biochemistry And Physical Chemistry

Masters thesis: Investigation of the Stereoselectivity of Antibodies Utilizing Tryptophan Fluorescence & the Effect of Deuteration.

Bachelor Of Science (B.S.), Biochemistry And Molecular Biology And Acs Chemistry

Activities and Societies: President of Chemistry ClubDouble Major. Two 2nd author publications. Hamaker, C.G., Corgliano, D.M..