Establish and maintain a GMP facility for the manufacture of topical Drug Products.Install, qualify, operate and maintain manufacturing equipment.Write , follow and train on SOP’s(Manufacturing, facility, Equipment, laboratory controls, Materials, Packaging, and shipping.Write GMP and Development Records (MBR, BR, Dev Protocols).Oversee laboratory safety programs.Work closely with Quality Assurance, Regulatory, and Drug Substance Process Development personnel.

o Develop and lead large and/or multiple programs, initiatives, and activities for the function of broad organization with moderate resource requirements, risk, and/or complexity.o Analyze and evaluate issues and make decisions within general parameters under little supervision.o Contribute to development of best practices for functional areas.o Communicate complex concepts and interact with others to inform and direct actiono Act as a "go-to" resource in own area of expertiseo Manage day-to-day activities for a project/ team comprised of professional employeeso Coordinate and collaborate with other teams to meet organizational goals and work requirementso Receive assignments in the form of objectives and determines how to use resources to meet schedules and goalso Determine methods and procedures on new assignments and coordinate activities of other personnelo Draft, review and edit SOPs related to all aspects of GMP operations.o Resolve issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trendso Follow processes and operational policies in selecting methods and techniques for obtaining solutions; solves moderately complex problems and able to identify viable and often innovative optionso Act as advisor to less experienced colleagues to meet schedules and/or resolve technical problems including having a strong understanding of the needs and knowledge bases of multiple departments to improve efficiency and produce high-quality work on problems with cross-functional impacto Identify and resolve technical, operational, and organizational problems/problems relating to own disciplineo Frequently work cross-functionally as the representative for areas of expertise. Develop design ideas and assists in future planningo Establish recognition within group as a technical expert, possibly in multiple techniques or specialty areas

o Developed the requirements needed to build in-house GMP ready drug substance manufacturing capabilities.o Developed in-house GMP-ready drug substances.o Identified, evaluated, and qualified new technologies related to fermentation, harvest, and lyophilization of anaerobic bacteria.o Contributed to studies and activities necessary for process optimization to ensure robust and cost-effective manufacturing processes of live biotherapeutics.o Created consistent and reproducible manufacturing processes and final drug substances.o Supported OOS, root cause, and CAPA investigations, as necessary.o Managed and executed troubleshooting activities, as necessary.o Transferred manufacturing operations to alternate sites, as appropriate, to ensure continuity of supply.o Worked cross functionally with the Drug Product Process Development group and analytical development.o Wrote technical reports.o Contributed to preparation and review of regulatory documents for submission to FDA and other regulatory authorities.o Identified and utilized expert consultants, when necessary.o Built and maintained a strong cooperative working relationship with colleagues in Drug Product, Analytical, Quality, Regulatory, Clinical Development, Project Management, and Legal.

○ Managed manufacturing operations including all procedures, batch records, components, to ensure that cGMP requirements are met.○ Coordinated the training and trained manufacturing technicians. ○ Managed short term and daily production scheduling.○ Supervised manufacturing technicians and oversaw all aspects of manufacturing and ensuring personnel are following SOP's.○ Assessed the value of new equipment and assisted in performing equipment qualifications.○ Started CAPA's as needed and assisted in Quality investigations.○ Troubleshoots manufacturing and formulation issues and assisted in the technical transfer into GMP operations.○ Assisted in manufacturing to meet scheduling demands when short staffed or scheduling demands are required.○ Updated senior management on approving overtime to reduce scheduling conflicts and maintain on time demands.○ Periodically reviewed equipment SOP's,○ Instructed hands-on training to technicians and ensured training records maintain up to date.○ Oversaw waste disposal operations and facility cleaningBend Research June 2012- October 2012o Supervised current Manufacturing Practices (cGMP) production staff, and provided support for execution of cGMP manufacturing, routine cleaning and equipment preparation. o Created and reviewed standard operating procedures.o Reviewed master batch records (MBRs). o Reviewed and approved logbooks associated with GMP production area and activities.

o Performed advanced operational and technical duties required to support new drug and dosage from development.o Provided technical support directed towards the expeditious approval of new drug entities, formulations and process enhancement for human veterinary markets. o Organized daily operations and trained professional and technical personnel.o Successfully implemented complex experimental designs, experiments trials, and pivotal manufacturing projects following global and local SOP’s.o Ensured proper safety and regulatory procedures were executed. o Ensured proper documentation was completed by reviewing Master Batch Records. o Executed minor calibration and PM work on small or system matter expert equipment.