Brian Byrd, Msc Email & Phone Number

Harmans, Maryland, United States

cGMP Manufacturing Supervisor of on-the-floor operations within a gene therapy manufacturing cGMP facility. Ongoing coaching, discipline and recognition of direct staff, including performance reviews.Realtime review of cGMP documentation.Serving as subject matter expert for GMP manufacturing and downstream process equipment including: Column chromatography (AKTA pilot and AKTA Process), viral filtration (Planova and Viresolve Pro Magnus Device) TFF (hollow fiber).Deviation, CAPA generation, root cause identification and investigations management using TrackWise.Master Batch Record and SOP authorship.

Timonium

Supervised the daily activities for a team of thirty technicians in a lean manufacturing environment. Responsibilities included: o Maximizing the performance of value streams by implementing and sustaining lean conversion principles in order to meet customer requirements.o Ensuring a safe working environment exists consistent with OSHA and company policies.o Lead and engage employees during Kaizens to drive continuous improvements.o Lead daily management to drive sustainable, continuous improvements in Safety, Quality, Productivity, On Time Delivery, and materials management. Report necessary counter-measures and problem-solving data to management in the daily management walkthrough and reviews.o Manage cost, quality, schedule, inventory and health, safety & environmental activities for two production locations.o Developing work cells for product families to develop state-of-the-art processes while using on-line process information, cross functional job descriptions and Kanban.

Lead cross functional project teams for new and returning clinical projects. Responsibilities include:o Driving cross functional communication by leading teams composed of functional managers to determine project facility fit and schedule.o Management of clinical tech transfer projects with the ability to create, coordinate, and maintain an integrated project plan and to control or respond to changes in strategy and scope.o Authoring downstream documents for multi-product clinical manufacturing (batch records, standard operating procedures, master specifications, solution preparation records).o Ensuring the adherence to the project schedule. o Serving as subject matter expert for downstream process equipment including: Column chromatography, viral filtration (Planova and Viresolve Pro Magnus Device) Utrafiltration/diafiltration and viral inactivation.o Ensuring the implementation and validation of new equipment is conducted in advance of production.

Supervised regular activities on a GMP production floor for a team of eight technicians. Responsibilities included: o Assignment of daily tasks. o Ensuring workplace safety and adherence to procedures.o Conducting safety walkthroughs.o Completion of at least one Six Sigma yellow belt project annually.o Providing input for technician’s annual performance reviews.o Serving as System matter expert (SME) for key downstream equipment and processes including: Column chromatography, Chromatography column packing, viral filtration, Utrafiltration/diafiltration and viral inactivation.o Assisting with the start-up of a new GMP manufacturing facility.

Played a key role in the startup and operation of a new Pilot Facility. Responsibilities included:o CIP and SIP recipe writing in RS Batch.o Site Acceptance Testing of Pall Chromatography columns o Validation of Pall chromatography skids and other process equipment.o Training of purification staff on downstream process equipment. o Execution of validation protocols. o SOP and Batch Record writing. o Operation of downstream processing equipment including: column chromatography (HS50, Protein A, Super Q, FractoGel, and HA); chromatography column packing, viral filtration, ultrafiltration/diafiltration, and viral inactivation.

Major contributor to ensuring right first time documentation and achievement of production goals. Responsibilities included:o Operation of processing equipment according to established Standard Operating Procedures (SOP’s).o Manufacturing of bulk biologics according to established Master Production Records (MPR’s) in accordance with Current Good Manufacturing Practices (cGMP’s). o Performing of downstream process steps, and protein purification/ separation techniques (e.g. membrane filtration, depth filtration, ultrafiltration and column chromatography). o Cleaning and sanitization of process equipment (CIP and SIP).

Utilized strong attention to detail and organization skills to ensure the achievement of departmental goals. Responsibilities included:o Reviewing of equipment logbooks and charts for accuracy and GLP compliance. o Management of a large inventory of clinical samples and critical reagent using sample management software.o Receipt and accessioning of clinical samples.o Resolution of discrepant patient information.

Bachelors Of Science Degree, Biology

Ms, Project Management