Duties included the preparation and editing of technical documentation in support of US Army and its clients' Regulatory Submissions to FDA for new and investigational drugs. The documentation being edited/prepared included initial submissions, IND submissions, Annual Reports, Clinical Reports, Protocols, and memos to FDA requesting meetings. Skilled in using SharePoint and EDMS documentation organization software, as well as MS Teams and Zoom virtual meeting software. Maintained a Government Security Clearance (Public Trust).

Duties included the preparation and editing of technical documentation for the Laboratory Operations Division (LOD) of the Army Public Health Center at Aberdeen Proving Ground. The documentation being edited/prepared included Technical Guides (TG), Fact Sheets (FS), Laboratory Information Documentation System (LIDS) Documents, and Standard Operating Procedures (SOPs). Skilled in using SharePoint documentation organization software, as well as MS Teams meeting software. Maintained a Government Security Clearance (Public Trust).

Responsibilities included overseeing the Technical Documentation Team (12 individuals), which was comprised of the Technical Writing Group, the Technical Auditing Group, and the CMC Regulatory Documentation Group. The groups prepared, edited, and audited analytical test methods, validation protocols and validation reports. The CMC Regulatory Documentation Group provided CMC documentation (such as Stability summary reports, Impurity tables, Residual Solvents Compliance Reports, Elemental Impurity Reports, COAs (Certificates of Analysis), Test Methods, Specifications, Justifications of Specifications, Validation Protocols and Reports, Stability Protocols and Post-Approval Stability Protocols) for pharmaceutical products including small molecules and biologics to the Regulatory Affairs Team to be included in CMC sections in ANDA and NDA Regulatory submissions for drugs for the treatment of oncology and endocrine diseases, high blood pressure, and others. The group also provided documentat

Analyzed formulated pharmaceutical products (small molecule) and APIs by HPLC and other techniques. Independently planned, executed, and interpreted work on complex analytical projects including stability studies. Wrote work plans including method validation, site qualification, and vendor qualification; wrote/revised SOPs (Standard Operating Procedures) and JHAs (Job Hazard Analyses) for the Analytical Group. Reviewed/revised test methods and specifications for APIs and drug products under development. Maintained familiarity with appropriate compendial methods, monographs, and GMP guidelines that supported product development. Provided supervision, training, and oversight to junior scientists.
• Project Leader for the analytical research and development of two veterinary pharmaceutical products, one of which was ultimately registered with the MHRA.
• Performed analytical methods transfer to Wyeth (Fort Dodge) Manufacturing Plants and CROs and assisted in

Analyzed formulated and technical pesticide samples for release and stability studies. Provided chromatographic support for product chemistry studies and new process development programs. Performed analyses resulting in the certification of product ingredients. Analyzed water and soil samples, as well as industrial hygiene samples for trace levels of pesticides.
• Led a collaborative effort to solve a complex chromatographic problem in which an impurity was co-eluting with a peak of interest, previously unknown to my company and a partnering company. Received a "Technical Achievement Award" for this work.
• Developed and validated HPLC and GC methods in support of two agricultural products which were ultimately registered with global regulatory agencies. Received a "Technical Achievement Award" for this work.
• Provided oversight for the Industrial Hygiene program at the Research and Development Center to p