Michaela Harding Email & Phone Number

Bethesda, Md, Us

Silver Spring, Maryland, United States

- Analytical testing of Phase I BioAnalytical products (mRNA based vaccines, recombinant proteins and mAbs, inactivated and live-attenuated vaccines) using - HPLC / UPLC, Gel Electrophoresis, qPCR, CGE, ELIZA, plate-based methods, SDS-Page, Western Blot, Coomassie Blue and Silver staining. - Method development for potency and Impurity profiles.- Method qualification of In-house developed methods and commercial kits. - Verification of USP compendial methods. - Stability testing support for new products. - Interpretation and analysis of experimental data.- Communication of analytical results and identification of the next steps to be taken.- Full compliance with all applicable cGMP regulations and internal SOPs. - Optimization of laboratory operations to increase efficiency and compliance. - Creation and maintenance of laboratory documentation (notebooks and computer-based).- Creation of Standard Operation Procedures (SOP) post method qualification.

Longmont, Colorado, United States

- Processed analytical methods for in-process analysis, release testing and stability monitoring of bulk drug substances and drug products under current Good Manufacturing Practice (cGMP) guidelines- Followed Standard Operating Procedures (SOP) and protocols for equipment, instrumentation and operations in cGMP process- Entered test results into Laboratory Information Management System (LIMS), generated reports, reviewed and analyzed trends and raised red flags for out of specifications results

Fort Worth, Tx, United States

- Performed laboratory activities to support method validations using analytical lab equipment and techniques- Generated protocols and reports, per current International Council on Harmonization (ICH), the Brazilian National Health Surveillance Agency (ANVISA) and the United States Pharmacopeia (USP) guidelines, for analytical method validation

Fort Worth, Tx, United States

- Notified customers for SOP, forms, specifications and procedures updates- Gathered all the relevant information for generating annual product reports- Supported Deviations, Change Controls, Investigations and CAPA activities related to product release- Gathered all required documentation to qualify new vendors and raw materials- Stability System – data entry, reviewed tests results and generated final reports- Received, logged and initiated customer inquiries and complaints- Maintained QA logbooks for document control

Fort Worth, Texas

- Strategic support to relevant quality processes regarding quality systems management of the site- Reviewed regulatory documents and verified accuracy against plant ERP systems- Re-evaluated 3600 records and remediated gaps by working with country’s regulatory affairs in generation of new regulatory documents- Assisted in any additional tasks to remediate gaps noted within quality system organization

Rehovot, Hamerkaz (Central) District, Israel

- Method development and validation- Analytical control of raw materials and finished products (HPLC, spectrophotometry, wet chemistry methods, etc.) - Worked according to in-house SOPs and various regulations (pharmacopeias and ISO)

Ashdod, Hadarom (South) District, Israel

• Lab work experience under GMP / GLP conditions• Analyzed finished products, in-process samples, process validation, and stability samples according to the various Pharmacopeias (USP, EP and BP) and to in-house test methods, using HPLC, GC, ICP, UV, FTIR, TLC, pH meter, wet chemistry and other analytical techniques• Analytical control of raw materials, comparing the results with the provided CoA’s and meeting the acceptance criteria• Updated testing methods according to the relevant Pharmacopeias (USP, EP and BP)

Master Of Science (Msc), Pharmaceutical Science And Management

Bachelor Of Science (Bsc), Life Science