Julie Wilber M.S. Email & Phone Number

Thorndale, PA, US

Philadelphia, Pennsylvania, United States

Provide support and overall leadership to a QC and Technical writing team to ensure efficient quality control functions in support of expanding gene therapy pre-clinical and clinical programs. Conduct quality review and approval of immunologic and bioanalytical data from pre-clinical studies and clinical gene therapy trials. Serve as Subject Matter Expert.

Philadelphia, Pennsylvania, United States

Established and expanded Quality Control and Technical Writing group in support of pre-clinical and clinical AAV gene therapy studies. Liaised between Clinical Operations and Sample Management to ensure compliant and accurate receipt, testing, storage, and disposal of clinical samples for Phase 1/2 studies.

Greater Philadelphia Area

Technical lead for transfer of cell therapy products from process development to commercial scale manufacturing. Served as Subject Matter Expert for interactions with clients, vendors, and external partners.

Philadelphia, Pennsylvania, United States

Provided direct support and leadership to the manufacturing of GMP cell therapy products within new commercial facility. Managed and led a team of up to 14 manufacturing associates including hiring and training. Authored and revised commercial GMP SOPs and batch records.

Exton, PA

Led a QC and Technical Writing team of five members to provide quality review of bioanalytical testing data and authorship of GLP testing reports. Managed timelines for deliverables to internal and external clients. Assisted in client audits and communications.

West Point, PA

Environmental Monitoring Specialist in sterile product packaging operations. Conducted environmental monitoring excursion investigations, including root cause analysis, trending, and CAPA generation, ensuring strict adherence to regulatory guidelines. Performed trend analysis and on-floor process simulation observations to maintain compliance with GMP.

Exton, PA

GMP Manufacturing Supervisor for cell therapy product production within ISO 7 clean room environments. Led and mentored a team of 10-12 manufacturing associates, ensuring high standards of compliance. Drove process improvements in manufacturing and environmental monitoring. Authored Standard Operating Procedures (SOPs) and Master Batch Records. Analyzed.

Lancaster, Pennsylvania Area

Established and created a mammalian cell banking function to expand cell banking business offerings for this contract lab specializing in pharmaceutical and environmental analytical services. Managed establishment and start up of two GMP cell banking suites including environmental monitoring and final fill validations. Developed departmental procedures.

Exton, PA

Oversaw manufacturing of cell therapy products in an ISO 7 cleanroom, led a team of 8-12 associates. Managed daily scheduling, performance reviews, and established departmental goals. Tracked key metrics and coordinated the testing and release of bulk and final products in collaboration with Quality Control and Quality Assurance. Contributed to process.

Master'S Degree, Regulatory Affairs/Quality Assurance

Bs, Biology