Science Teacher

Start-up small diversified organic farm. Includes, fruits, nuts, vegetables, chickens, and soon adding cows.

Science Teacher

Provided validation and qualification support for Production vessels by drafting and executing validation protocols, analyzing test result data, and drafting final reports for cGMP vessels ranging in capacity from 25 to 500 Liters. Performance qualification parameters include cleaning, mixing, and monitoring aseptic sustainability of vessels. Supported process validation drafting process validation protocols for Zone 1 and Zone 2 areas. Provided commissioning and Installation/Operational support for GE Axichrom SEC chromatography columns, performing the commissioning, installation and operational qualifications.

Review and support of GMP documentation; SOPs, instrumentation qualifications and supporting documentation; analytical method transfers, validations and verifications, protocols, data review, reports; raw material qualification (USP and EP, compendial and noncompendial), EM, sterility, endotoxin testing, and validation plans for start-up USFCC facility, ensuring quality and regulatory compliance. Reviewed documents from the disciplines of Microbiology, Raw Materials, Chemistry, Biochemistry, Virology, Manufacturing, and Commissining and Qualification.

Transferred R&D testing methods into QC cGMP environment, drafted and performed transfer protocols, established method performance acceptance criteria, wrote the corresponding SOPs, performed and supervised testing, wrote training materials and trained analysts. Drafted protocols and reports, and performed test method validations/qualifications. Orchestrated routine instrument calibrations, PMs and performance verifications using Blue Mountain CalMan, LACES/LIMS and Excel software. Initiated investigations, provided technical support to investigators and performed testing instrumental in closing the investigations. Maintained laboratory supplies using SAP-SRM and B2B procurement systems software.

Assessed status of analytical method validations and helped plan a compliance strategy. Developed and implemented retroactive qualification/validation procedures for analytical test methods. Provided expertise and performed trouble shooting procedures for cGMP chemistry laboratory. Researched and developed methods to assure quality control of test methods, instruments and other laboratory procedures. Assisted in IQ, OQ and PQ of new instrumentation. Served as team member in technology transfer from Vaccine Development into the Quality Control department.

Served as lead on research and development, validation, and implementation of quality assurance protocols in order to determine stability of pharmaceutical products following ICH and GMP guidelines. Developed techniques and selected instrumentation to evaluate viability of in vitro tissue as well as the methodology to understand tissue physiology after xenographic transplantation. Managed and trained employees conducting the research.

Performed and oversaw R&D in the areas of Endocrinology, Physiology, and Biochemistry. Projects ranged from establishing drug efficacy and drug dose response on patients through adipose biopsies cultures to drug response through electrophysiology of canine tracheal membranes.