Bryan Fluke Email & Phone Number

Raritan, New Jersey, Us

• Act as subject matter expert for aseptic process simulation and particle study evaluations and as well as manufacturing, facility, and environmental monitoring investigations in a clinical CAR-T manufacturing facility. • Author and update the Biocontamination Control Strategy in partnership with the Site Microbiologist, lead and participate in regulatory and technical gap and ricks assessments and produce technical protocols and reports. • Open, own, and assess change control records. • Implement Continuous Improvement projects to save time and money. • Supporting data lake integration of Spring House GMP Facility manufacturing execution system and eLIMS results.• Maintain training compliance for operations staff as the Learning Management System Administrator.

Raritan, New Jersey, Us

Participate in technical transfer of products for clinical manufacturing of CAR-T therapies in an early phase clinical facility. Support clinical manufacturing of CAR-T therapies by completing process, facility, and in-process environmental monitoring investigations, implementing and executing the aseptic process simulation and particle study programs, and authoring campaign summary reports and operating procedures.

Wyomissing, Pa, Us

Support building, utility, equipment, and process commissioning and qualification efforts for RPA Engineering clients in FDA regulated and non-FDA regulated industries. Responsibilities include managing projects , providing technical guidance on mechanical, automation and quality topics, and acting as an internal RPA Engineering compliance consultant. Projects include:-Support for a client clinical CAR-T facility startup, including documentation for aseptic process simulations, particles, investigations, and operating procedures.

Wyomissing, Pa, Us

Manage building, utility, equipment, and process commissioning and qualification efforts for RPA Engineering clients in FDA regulated and non-FDA regulated industries. Responsibilities include managing project and onsite personnel, providing technical guidance on mechanical, automation and quality topics, and acting as an internal RPA Engineering compliance consultant. Additional responsibilities include managing the Philadelphia satellite office for RPA Engineering.

New Brunswick, Nj, Us

Manage 3rd party service providers, contractors, timelines, and budgets to complete projects requiring new processes, equipment and / or facility modifications to pilot plant production and laboratory facilities. Responsibilities included leading and participating in cross functional teams, implementing and maintaining a 3rd Party outsourcing program for computerized lab instrument qualification and compliance across 4 sites, engineering services for technology transfer into and out of a clinical manufacturing facility, and technical support for non-conformance event investigations and risk assessments. Examples of technical projects worked on include establishing disposable processing technology such as single use bioreactors and ultrafiltration systems in a clinical manufacturing environment and introducing cell therapy production into an existing monoclonal antibody facility.

Downingtown, Pennsylvania, Us

Generation and execution of Installation / Operational / Performance Qualification protocols and factory acceptance testing documents. Equipment includes HVAC systems, compressed air systems, water / clean steam generation systems, fermentor, homogenizer, portable clean in place (CIP) system, ultrafiltration / diafiltration (UFDF) skid, chromatography skid, centrifuge, process tanks and pumps, and biological safety cabinets. Performance Qualifications were performed using water or media for the SIP of two process vessels and a fermentor.

Troy, Michigan, Us

Process Engineer in Vaccine Engineering department at Merck & Co.'s West Point, Pa facility responsible for supporting the start-up for a new facility for the purification of an HPV vaccine. Provided floor support for microfiltration, ultrafiltration, sterile adsorption, CIP and SIP processes, implementation of filtration use and reuse technologies, documentation for new raw materials, and execution of factory acceptance testing protocols.

Bs, Chemical Engineering

Bs, Business Administration