Started on the first shift supervising over 65 Union Operators in the multi-product Packaging Department for two months. Transferred to the third shift after my second month and was asked to oversee the cleanroom filling and cleanroom cleaning operations and then the compounding and packaging operations as well with a total of over 45 Union and Non-Operators. In addition to growth on both shifts, I successfully managed the processes and facility as well.• Establishes well organized teams, create and develop leaders.• Standardizes processes and establishes cross functional standards.• Decreases department nonconformance, documentation and safety rates.• Continuous improvement minded, initiatives implementation driven and leadership standout.

Built up a 2nd shift team from 13 to 35 Technicians and grew the shift from 1 human tissue process to 4 human tissue processes in a cleanroom environment all within the first 3 months of employment. Also built a 3rd shift team from 15 to 23 Technicians and grew the shift from only cleanroom cleaning responsibilities to 8 human tissue processes also in a cleanroom environment in addition to maintaining the cleanroom cleaning responsibilities. In addition to growth on both shifts, I successfully managed the processes, facility and the people as well. • Established well organized teams, created and developed leaders.• Standardized processes and established cross functional standards.• Decreased department nonconformance rates.• Out of the box thinking approach in regards to continuous improvement and leadership development. • Authored batch records, SOPs, and technical documents. • Led department Lean initiatives.

Manufacturing Supervisor II – Purification, 2004–2010Manufacturing Supervisor II – BioService Support, 2003–2004Selected to serve as interim Manager and oversee two departments for nine month period during organizational transition period and directly involved with professional development and promotion of employees to management level positions.•Managed Class 10,000 Purification and Buffer Preparation operations for Commercial Manufacturing department. •Ensured employees were trained in Purification processes and operated in compliance with cGMP, Quality Assurance and safety standards by providing on-going training on Standard Operating Procedures (SOPs), batch record documentation and yearly cGMP requirements.•Provided technical and operational process development for 10 direct reports along with assigning and reviewing work order requests.•Decreased production batch records pages by 50%.•Led major process related investigations and closed within allocated timeframes. •Served as main liaison for several successful FDA and regulatory agency inspections.•Authored numerous batch records, SOPs, and technical documents. •Worked closely with Engineering, Facilities, Validation, Manufacturing Technology, Metrology, Logistics and Quality departments.•Assisted in the implementation of StarLIMS, ELM (Electronic Learning Management), Pilgrim (Electronic SOPs and batch record system) and eTime (Electronic Time Management) initiatives to staff.

Sterile Production Supervisor/Associate ManagerPromoted from Supervisor to Associate Manager and hand-picked to help run department during Manager’s six month sick leave.•Oversaw production of 40 Operators and worked closely with Consultants, Engineers and Quality Assurance staff on demolitions and clean builds. •Increased production by 10% by streamlining process set-ups and reallocating staff.•Managed Class 100, 10,000 and 100,000 Cleanroom production operations including liquid and lyophilized filling operations, parts preparation, compounding and production packaging operations. •Conducted ongoing cGMP and SOPs training for 40 production personnel.•Recognized for two successful FDA audit interactions.

Microbiologist, 1998–2000 & 1993–1995 Accelerated advancement (started as temporary employee) through a series of increasingly responsible positions within Aseptic Filling and Microbiology departments.Revised sampling plan for building’s main water treatment system.Monitored Class 100 Cleanroom environments.Performed product sterility testing via isolation technology, reading monitoring media, laboratory assays and water collection and testing.Trained production Operators on microbiology sampling and revised SOPs.Sterile Production Filling Supervisor, 1995–1998Managed production operations for Class 100 Cleanroom powder filling and liquid filling areas, packing operations and all associated production batch records and deviation reports.Oversaw batch compounding, component and parts preparation operations in Class 10,000 Cleanrooms and monitored the water system.Implemented LIMS and batch record reduction implementation initiative and assisted with online operation of liquid filling.Prepared and updated SOPs requiring no additional revisions.Conducted monthly cGMP and first aid training for 16 union personnel.