Robert Casey Email & Phone Number

Seattle, WA, US

Capital Projects and Senior Technical Services Lead for Just-Evotec Biologics

Seattle, WA, US

Driving facility start-up and operational readiness efforts at site in Toulouse (J.POD EU) and leading operational readiness for site expansion in Redmond (J.POD US)

New York, New York, US

Bothell, Washington, US

Building new Launchpad biomanufacturing facility to expand Seagens's pipeline of ADC cancer therapeutics.

Seattle, WA, US

Leading global expansion team to increase access to biotherapeutics with Just-Evotec's novel J.POD continuous manufacturing technology.

Seattle, WA, US

Seattle, WA, US

• Golab was Seattle’s first certified mobile lab bringing same-day PCR and rapid COVID-19 testing directly to the patient. We partnered with Washington’s leading employers, public health departments, campuses, events.
• Served and tested 30,000+ patients throughout the COVID-19 pandemic, from essential workplaces and care facilities to professional athletic teams, Fortune 500 companies, and Live Nation events.
• Developed business growth strategy and built experienced medical team of Washington state registered nurses and lab technicians, beginning as a bootstrapped start-up and growing to profitable seven figure revenue for.
• Secured partnerships with Public Health- Seattle and King County and Seattle Sounders Football Club MLS team as exclusive mobile testing provider
• Created laboratory safety protocols and standard operating procedures in compliance with all Washington Department of Health, CLIA, and federal HIPAA regulatory standards; developed SOP training program for GoLab staff
• Formed community charity partnerships with Mary's Place, Childhaven, Goodwill, New Horizons, and Youthcare. For every patient we test, GoLab donates a portion of all proceeds to our charitable partners.

Tokyo, JP

• Planned commissioning and qualification of downstream equipment of Shire’s new disposable production facility.
• Implement Risk-Based Verification (RBV) approach: gathering cross-functional inputs; authoring and securing pre-execution approvals for RBV documents for assigned systems.
• Ensured adequate resources are applied within the costs constraints of the project to achieve project goals; escalate any resource constraints or conflicts proactively across teams.
• Determine and coordinate automation testing with the Project Automation team that will be required as part of the equipment/system(s) assigned in the CQV Lead scope.

Tarrytown, New York, US

• Led the process engineering team through the successful qualification of two new process lines, including: start-up and regulatory approval of the Raheen facility; technology/process transfer of three commercial.
• Served as Regeneron’s Subject Matter Expert during technical investigations and regulator inspections (FDA, HPRA)
• Designed and specified cGMP process equipment, piping and controls
• Partnered with Validation Department in preparation and execution of qualification protocols
• Served as technical advisor for Manufacturing, Technology Transfer and Maintenance activities
• Recruited, led and developed engineering team talent and provided compliance training

Tarrytown, New York, US

Basel, Baselstadt, CH

• Led the Vaccines Process Engineering team through multiple facility optimization and process robustness projects and commercial campaigns (batch/day flu vaccination commercial campaigns)
• Led Process Engineering design for capital investment projects (Solutions Preparation and Bacterial Fermentation Facilities)
• Facilitated site HAZOP program and served as Subject Matter Expert for regulatory inspections (FDA, MHRA)

New York, New York, US

• Represented Pfizer’s Process Engineering function for Tanezumab technology transfer project to the Andover Pfizer facility
• Provided technical support as a Subject Matter Expert on all upstream operation, including inoculation, wave bioreactors, production bioreactors and cell culture harvest operations for successful process validation and.
• Approved departmental production deviations ensuring appropriate use of Six Sigma tools to determine root cause and confirm appropriate CAPAs were implemented
• Designed and approved batch records and SOPs (Standard Operating Procedures) during facility start up
• Obtained Six Sigma Green Belt Certification using RFT, Opex Tools & Lean Principals
• Provided technical support during IMB regulatory inspection

New York, New York, US

• Led process engineering for the inoculation laboratory, seed bioreactors & media preparation suites.
• Supervised construction for ongoing safety process improvement projects including the management of mechanical sub-contractors
• Executed equipment commissioning, validation, cleaning validation & Steam In Place performance qualification (SIP PQ)
• Facilitated chemical contamination FMEA
• Led diaphragm and gasket study to amend ECO (Elastomer Change Out) Frequency