Oversee projects for Manufacturing that includes project plan development and project plan execution tracking and project completion activities.Attend appropriate meetings to gather and report out on issues and/or opportunities existing with Manufacturing Operations.Apply best practices in project management and resource management. Assess team project resource capacity, analyze against project demands, identify resource gaps and develop remediation plans to deliver projects.Actively develop, promote, and implement safe work practices to ensure safe working conditions for all employees.Manage the day-to-day business operations of the organization with facility and organizational readiness initiatives to drive successful Manufacturing Operations.Oversee and support GMP readiness activities for manufacturing area start-up and new product introduction.Support CAPAs, Change Controls, and Deviations as needed.Responsible for owning the detailed Vector manufacturing operations schedule, including scheduling of programs, personnel, maintenance, and qualification activities.Deliver Vector Manufacturing updates on metrics, project milestones, pipeline, etc., as needed with presentations or in business meetings.Develop files and metrics to track project status, support value generation of activities, and to support communication efforts.Proactively identify opportunities for improvements in process, safety, quality, and cost. Assist with RFPs and proposals for Vector programs.Manufacturing Operations lead for GMP readiness activities for Manufacturing.

Author, revise, and review SOPs, WIs, Training Guides, Forms, and Batch Records to support facility stand-up activities and GMP readiness.Designed the Aseptic Manipulation Test (AMT) to be used across the entire company for qualifying employees to work inside a BSC. Supports continuous improvement efforts across multiple departments.Ensure direct reports are on track with training and stand-up tasks.Implemented Safety Shoe Program to be used across the entire company. Assist in the stand-up and execution of the manufacturing training program.Designed the Process Flow Diagram (PFD) for gowning into a BSC in a Grade C suite.Support and guide both associates and management with knowledge and stand-up tasks.Established relationships with QA, PD, TT, F&E, and Automation for interdepartmental collaboration and communication.Assists with and performs manufacturing operations for Gene Therapy products.Trains personnel on proper aseptic technique, gowning, GDP, GMP, and equipment operations.Troubleshoots equipment and remedies communication issues between departments.Authors Master Batch Records (MBR), Bill of Materials (BOM), and Process Flow Diagrams (PFD) for Process Development’s (PD) Pilot runs for a new suspension process for a client.Completes comment resolutions for PD Pilot documents from internal and client reviews.Built and maintains a master library for all components ordered from FlexBioSys to include links to updated drawings, descriptions on the materials, and SAP ID#s utilized by Manufacturing, PD, Tech Transfer, Support Services, QA, and MSAT.Design scaled up process for Pilot run of client process to prepare for GMP production.

Maintain working relationships with Validation, QA, QC, Support, Facilities, Engineering, and Downstream to provide seamless communication for processing needs.Ensure manufacturing personnel follow SOPs, Batch Records, and controlled documents during production to comply with safety and the Food and Drug Administration (FDA) regulations. Strictly adhere to Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) while preparing media, performing cleanings, and participating in production activities. Provide hands-on training, mentoring, technical input, and operational guidance to operators on upstream production procedures.Author and revise Standard Operating Procedures (SOPs) revisions, Batch Records, and Solution Preparation Records, Protocols, and Reports as needed to accurately reflect manufacturing processes.Identify and support continuous improvement initiatives.Ensure direct reports are on track with training by adjusting operation assignments.Possess working knowledge and hands-on experience of fermenters, holding tanks and harvest equipment for pharmaceutical production of a biosafety level 2 organism.Seamlessly work independently and as a lead in a team environment. Perform, troubleshoot and support fermentation-related validation procedures as required.

Responsible for manufacturing of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).Follow regulatory compliance requirements for the production of biologics.Adhere to procedures to ensure to maintain the clean room environment to comply with regulatory requirements.Provide training and operational guidance in manufacturing processes to newer employees.Successfully work in a team environment and independently as required.Interact with members of other departments such as QC, QA, QAR, Login, Testing or Facilities to coordinate e.g. sample submission or communicate equipment failures or service requirements. Perform manufacturing process for production of clinical and commercial Cell & Gene Therapy products, Master and Working Cell Banks, and final product fills. Proficient with the development and execution of upstream and downstream manufacturing processing. Demonstrate and maintain technical knowledge of immunotherapies, signal transduction cascades, and industry trends for incorporation in process improvement strategies.

Weighed out various chemicals for making batches. Cleaned and steamed various tanks, equipment and lines. Supported the upstream and downstream process. Retrieved and analyzed trend charts and process data on trained procedures. Takes necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors. Responsible for setting-up and operating manual and semi-automatic production equipment to produce clinical and commercial products (purification tanks, sterile/non sterile hoods, mechanical press, autoclave, depyrogenation oven, bioreactors).

Conducted in-process inspection of media filled sprayers and bulk samples, verified weigh performance and evaluation of media fills for frozen Flu Mist operation.Transferred tanks, carts and equipment into clean room; participated in operation and maintenance of walk-in cold roomsPrepare and formulate specialty cleaners and/or solutions, etc. needed for cleaning and/or to be used in the manufacturing processes and/or support areas where specified by standard operating procedures (SOPs) to ensure efficient cleaning and decontamination of all areas and equipment.