BIOGEN, Senior Process Engineer/Manufacturing Scientist, 2013 – 2015 EISAI, INC., Principal Process Engineer Technical Operations, OSD 2011 – 2013 (Biogen purchased RTP Eisai site in 2013; maintained same role.)+ New Product technology transfer support from Research and Development to Production.+ Departmental SME for new equipment and facility design.+ Responsible for process validation protocol and batch record writing, review, and execution.+ Trained production technicians on Batch Documents, SOPs, protocols and new processes.+ Process Optimization protocol writing, executing, and evaluating.+ Investigated deviations and CAPA implementation.+ Collaborated with Engineering and Validation on equipment URS and qualification.

+ Performed investigations applying root cause analysis techniques.+ Developed and implemented CAPA for exception reports.

+ Led, managed, and facilitated all drug product processing activities.+ Performed investigations, troubleshooting, report deviations, and developed CAPA for atypical events.+ Selected, hired, trained, evaluated performance, and motivated manufacturing staff.+ Reviewed, modified, and approved critical documents (Batch Record, IQ/OQ, SOP).+ Met production schedules, budgets, and ensured timely maintenance repairs.+ Reviewed and approved departmental equipment and parts purchases up to $25,000.+ Interacted with other departments to achieve departmental and plant objectives.+ Managed inventory reduction process in manufacturing resulting in 25% WIP reduction.

+ New Product technical transfer support from Research and Development to Production.+ Processed Validation and Batch Record writing, review, and execution.+ Trained production technicians on Batch Documents, SOPs, protocols and new processes.+ Process optimization protocol writing, execution, and evaluation.+ Investigated deviations and CAPA support.

Performance qualification/process validation/cleaning validation writing, reviewing and execution.+ Responsible for validation change control writing and reviewing. + Investigate atypical QC analytical results using statistical tools.+ Batch Document, SOP, Protocol and Evaluation writing, reviewing and implementation.+ Supporting production, troubleshot process issues on a 24-hour rotating schedule.+ Trained production on batch documents, SOPs, protocols and new processes.+ Effectively managed product transfer project from sister site in France.

Production Supervisor-Dry Powder Inhalers (2002 – 2007)Production Supervisor-Metered Dose Inhalers (2000 – 2002)+++++Foundational Career Experience:+++++ API Manufacturing Supervisor + Provided leadership and guidance to staff of eight to 24 production leads, operators, and mechanics.+ Reviewed and approved critical validation documents (IQ/OQ).+ Behavioral Accident Prevention Process Facilitator (safety program).+ Ensured compliance with SOP, JSA, cGMP, GSK Policies, FDA and OSHA requirements.+ Conducted Quarterly Self Inspection Audits of all Production areas.+ Investigated, wrote, and recommended preventive actions for Quality Notifications.+ Created and updated MDPI Production Output Excel spreadsheet daily.+ Tracked batch yields and rejects, investigated atypical trends.+ Wrote, reviewed, and modified critical documents (Batch Document, SOP, JSA).+ Conducted performance reviews and implemented yearly salary increases/bonuses.+ HAZMAT, Fire Brigade Team Member, and Incident Commander. + Daily confined space entry and work permit authorization.+ Purified water regeneration and monitored for API processes.API Manufacturing In-Process Chemist + Analyzed samples for: completion of reaction, in-process assay, impurities, environmental spill, flammable wastes, waste streams, loss on drying, and cleaning validation. + Developed cleaning validation methods and in-process testing procedures. + Operated, calibrated, maintained, and repaired instrumentation including HPLC, GC, IR, UV, NMR, X-ray diffraction, and Particle Size Analyzers.