Christian Rust Email & Phone Number

• Authored, reviewed, and executed developmental protocols and reports, technical memos, and standard operating procedures for the successful startup of new drug product facility• Led tech transfer activities including VHP Cycle development and alarm criticality assessment and response for inline vial washer, laminar air hood, depyrogentation tunnel, grade A isolator, and peristaltic pump vial filling line.• Composed and assessed contamination and particulate risk assessments across the drug product suite. Mitigated risks to acceptable level with design controls, and implementation of procedural and qualification controls. • Mentored the development of junior engineers and cross-functional engineering team

Bioprocess Scientist• Executed lab-scale batch development runs, performed data analysis, and presented findings to support product commercialization• Supported commercial manufacturing by designing and conducting developmental studies, writing technical reports leading trainings, and sharing best practices on equipment usage and process procedure• Facilitated manufacturing start-up end-to-end review (make a batch) for harvest and downstream unit operations

Process Engineer• Managed process equipment design, purchase, testing, and turnover, coordinating activities with vendors, calibration technicians, and the construction and engineering teams to deliver assets for the rapid 60-day turnaround of a commercial facility undergoing a change in product and a 5-month turnaround of a facility retrofit from project kickoff to completion• Authored commissioning and qualification protocols and led troubleshooting efforts for compliant testing of process equipment with inputs from internal site operations, tech ops, and quality groups as well as external partners• Performed HAZOP assessment and PHA review and action item completion for new equipment installations• Trained site team on equipment safety, setup, best practices, and supported PPQ to ensure seamless transition to site team

Technical Operations• Conducted six sigma multivariate analysis on cell growth and vial defects to support process continuous improvement • Built automated tools for CPV report data validation and generation, and virtual tier board visualizations• Led technical investigations and mitigation efforts impacting manufacturing processes, facilities, and equipment• Authored and updated technical and manufacturing documents including process change controls, standard operating procedures, technical protocols, and corrective and preventative actions• Designed new harvest sterile assembly and media formulation setup for improved sterility assurance and 30% capacity increase per batch for a new greenfield facility • Interfaced with regulatory inspectors providing SME support

Kingsport, Tennessee, Us

• Streamlined near-infrared (NIR) photometer calibration for vacuum dryers and developed novel glass standards calibration methodology for NIR moisture analyzers• Conducted DOE and built multivariate model to determine inline chemical concentration with NIR spectroscopy

Lexington, Ky, Us

• Successfully layered mesoporous titania onto a porous substrate via evaporation-induced self-assembly• Characterized these films using X-ray diffraction, flux measurements, grazing incidence small angle x-ray scattering, and scanning electron microscopy

• Founded business that provides unskilled labor to residents of the local community. • Led marketed campaign adding over 100 customers to the RBLS network• Managed 3 employees and their client schedules and company finances

Bachelor Of Science (B.S.), Chemical Engineering

Bachelor Of Science - Bs, Textile Sciences And Engineering

High School