Wearing many hats...more details to come.

Govern on-the-floor CAR-T cell therapy manufacturing in a cGMP environment. Key Contributions: Collaborated with Materials Management in implementing an initiative to reduce the number of items kitted to Manufacturing for production Manufacturing Point-of-Contact in a concerted effort to implement a new electronic batch record system. Create a 4-tiered level cutter for Operators on manufacturing floor facilitating hiring outside senior talent, as well as guide and coach internal staff on attributes needed to advance. Reduced cycle time by streamlining production methodologies to ensure on-schedule production, within quality standards and operational budget.  Assure meticulous SOPs and documentation enforcing that product meets all requirements for safety, quality and efficacy, including passing FDA inspection and approval.  Instrumental contributor to hiring of 200 new employees in one year due to growth of company. Consistently exceed production capacity targets that are based on demand predictions.

I supervised 16 personnel and three Lead Operators in daily manufacturing operations of the human-derived plasma Albumin.  Presented weekly “report outs” to Senior Leadership.  Drove utilization of Lean Manufacturing principles, striving for optimal efficiency.  Teamed up to develop and enforce a Kanban system for manufacturing area with high volume of material ingress and egress.  Strived for reduced process cycle time, waste mitigation and reduction and automation, electronic batch management (EBM) system interaction efficiencies. Key Contributions: Collaborated with cross-functional project teams: Validation, Manufacturing, Quality Operations, Quality Validation, IT and Technical Services resulting in company savings of $575k over six months; and reduced cycle time by 40% for a large buffer makeup operation. Recruited to train and mentored two supervisors during six-month development program. Prime lead in creation of process map to dictate headcount numbers for new building. Awarded Department Safety Champion, represented multiple departments as the Value Improvement Project (VIP) Champion.

I supervised up to seven personnel in day-to-day operations of Buffer Prep area, supported two different plasma-based manufacturing processes, and led cross-functional teams on common goals.  Coordinated with other supervisors to create and update production schedule, and with Maintenance and Metrology technicians/planners for routine maintenance and calibration activities without impeding production throughput.  Partnered to evolve manufacturing process with tracking tool to improve cycle time.  Executed Validation, Engineering and Technical Services protocols involving PQ and PPQ activities. Key Contribution: Led tour and interviewed by auditors resulting in successful FDA pre-licensure inspection. Managed Conformance Lot production of product, leading to submission and FDA approval.  Oversaw production increase that reached building capacity ahead of schedule.  Awarded Improvement Project Champion for Manufacturing and Quality departments.  Recruited to train and mentor Operation Development Program (ODP) Associate. Appointed Project Leader for ramp up projects.  Designed and amended SOPs in partnership with Manufacturing, Quality and Engineering staff.

Positions: Served on the IG (immunoglobulin) Bulk Purification SME and EBM development team, Automation and Process Engineering. Member of Small Parts Management and Transfer Panel Management teams. Environmental Health and Safety (EHS) Representative for the IG department.  Directed UF/DF and Sterile Filtration unit operations startup for the IG Bulk Purification team.  Composed SOPs, Job Aids and EBM Process instructions for UF/DF, Sterile Filtration processes. . Participated in execution of three Clean-In-Place (CIP) skid Factory Acceptance Testing protocols.  Reviewed Material of Construction documentation, verified Weld Maps/Weld Logs, performed spray ball coverage testing and skid instrumentation verification.  Presented local site and select company-wide safety incidents to team members along with weekly safety tip.Key Contributions: Designed Electronic Batch Management System.  Created five year forecast of consumable and small capital expenditures. Expanded training curriculum and designed small-scale purification skids for training purposes. Devised methodologies for handling, hygienic status tracking with EBM of non-identifiable parts and transfer panel jumpers that are used facility-wide.  Analyzed and updated Functional Requirement Specifications (FRS), User Requirement Specifications (URS), and Detailed Design Specifications (DDS). Led assessment, development and creation of the small cap expenditures and consumable list needs for commissioning activities through commercial production startup for the IG Bulk Purification Team.  Constructed and presented slide deck to all of Manufacturing including Directors and Managers at Manufacturing Symposium. Topics: UF/DF and Sterile Filtration process, Plasma-based Therapies, UF/DF CIP cycle and Baxter Covington Water Systems.