Experience

Cook MyoSite

• United States
• Biotechnology Research
• 100 - 200 Employee

• Supply Chain Planning Manager

  • May 2023 - Present

• Senior Supply Chain Planning Specialist

  • Mar 2022 - May 2023



rose plastic medical packaging

• Germany
• Packaging and Containers Manufacturing
• 1 - 100 Employee

• Director of Quality Management - North America

  • Apr 2021 - Mar 2022

• Quality Manager

  • Mar 2020 - Mar 2021



Cook MyoSite

• United States
• Biotechnology Research
• 100 - 200 Employee

• Production Manager

  • Jan 2016 - Mar 2020

  Oversaw manufacturing of both cGMP and Research Use Only (RUO) cellular products · System owner of a cGMP manufacturing suite including both ISO 7/ISO 8 room environments and ISO 5 Biological Safety Cabinets · Provided leadership to direct reports and supervision leads within the Production department · Responsible for creating and revising quality system documents including SOP’s, change controls, and CAPA implementations · Identified process gaps and implemented solutions · Responsible for… Show more Oversaw manufacturing of both cGMP and Research Use Only (RUO) cellular products · System owner of a cGMP manufacturing suite including both ISO 7/ISO 8 room environments and ISO 5 Biological Safety Cabinets · Provided leadership to direct reports and supervision leads within the Production department · Responsible for creating and revising quality system documents including SOP’s, change controls, and CAPA implementations · Identified process gaps and implemented solutions · Responsible for departmental approvals of validation documentation as system owner (IQ, OQ, PQ) · Managed investigations, including responsible for approval of investigations associated with manufacturing · Manufacturing and Operations lead for internal and external audits · Use of SAGE ERP system · Project lead for departmental initiatives (i.e. quality system revamp of operations procedures, shut down planning and recovery) · Technology transfer manufacturing lead

• Cell Culture Production Supervisor/ Team Lead

  • Apr 2014 - Dec 2015

  •Executes daily production schedule to ensure safe and timely completion of releasable products. •Provides direct guidance to employees to ensure operations meet company quality system, SOPs, and cGMP requirements. •Performs production and related tasks and provides general supervision of a work group, assigning tasks and checking work at regular intervals. •Completes and ensures timely review of Production Batch Records and associated documentation. •Suggests methods to ensure… Show more •Executes daily production schedule to ensure safe and timely completion of releasable products. •Provides direct guidance to employees to ensure operations meet company quality system, SOPs, and cGMP requirements. •Performs production and related tasks and provides general supervision of a work group, assigning tasks and checking work at regular intervals. •Completes and ensures timely review of Production Batch Records and associated documentation. •Suggests methods to ensure process success and improve efficiency of operations. •Assists with product or process-related investigations. •Participates in the hiring, developing, and training of new employees. •Assists in the performance of staff reviews. •Ability to obtain and maintain gowning and aseptic qualification. •Participates in implementing new technology or equipment into the manufacturing process and in expansion of manufacturing activities. •Assists in in ensuring functional unit’s compliance with company SOP’s and cGMP and all of its related elements such as facilities, documentation, training, reports and records. •Performs all duties of the Cell Culture Production Associate and Assistant as needed.

• Cell Culture Production Associate

  • Mar 2013 - Apr 2014

  •Performs a variety of production tasks (e.g. preparation of bulk solution, media preparation, filling and labeling of vials under sterile conditions, aseptic manipulation of cell cultures) in strict accordance with the company quality system, SOPs, and cGMPs. •Executes daily schedules to ensure safe and timely completion of releasable products. •Completes and reviews Production Batch Records and associated documentation in a timely fashion. •Troubleshoots processing problems, brining… Show more •Performs a variety of production tasks (e.g. preparation of bulk solution, media preparation, filling and labeling of vials under sterile conditions, aseptic manipulation of cell cultures) in strict accordance with the company quality system, SOPs, and cGMPs. •Executes daily schedules to ensure safe and timely completion of releasable products. •Completes and reviews Production Batch Records and associated documentation in a timely fashion. •Troubleshoots processing problems, brining unusual problems (i.e. potential deviations) to the attention of the supervisor. •Executes own daily workload schedule and relevant resource requirements. •Assists in the implementation of production procedures to optimize manufacturing processes. •Participates in the transfer process of new products to production. •Assists in providing training to new personnel in both general and specific technical processes. •Participates in plant in plant trials for evaluating process modifications or new technology or equipment. •Performs all duties of Cell Culture Production Assistant as needed.

• Cell Culture Production Assistant

  • Oct 2012 - Mar 2013

  •Assists in the performance of a variety of production tasks (e.g. routine cell culture monitoring, solution and material preparation, assay performance) in strict accordance with company quality system, SOPs, and cGMPs. •Prepares manufacturing suite for daily/ shift activities. •Executes daily schedules to ensure safe and timely completion of releasable products. •Assists in ensuring the availability of adequate resources (equipment, materials, personnel, documentation, etc.) for the… Show more •Assists in the performance of a variety of production tasks (e.g. routine cell culture monitoring, solution and material preparation, assay performance) in strict accordance with company quality system, SOPs, and cGMPs. •Prepares manufacturing suite for daily/ shift activities. •Executes daily schedules to ensure safe and timely completion of releasable products. •Assists in ensuring the availability of adequate resources (equipment, materials, personnel, documentation, etc.) for the completion of daily production tasks. •Maintenance, preparation and operation of equipment/components for work tasks. •Sanitation of aseptic processing and filling rooms and maintaining familiarity with federal and international regulations pertaining to manufacturing processes. •Assists in the implementation of production procedures to optimize manufacturing processes. •Troubleshoots processing problems, brining unusual problems (i.e. potential deviations) to the attention of the supervisor.