Ryan Simons Email & Phone Number

Oceanside, CA, US

San Diego, California, US

San Diego, California, US

• Lead Engineering runs at a Hybrid-type CMO (CMO MFG operators and Angiocrine MFG operators) for scale-up operations using an alternate Single-Use Bioreactor (SUBs) system in prep for commercialization activities.
• Helped improve the scale-up process at the Hybrid CMO which contributed to a 50% increase in drug product output.
• Provided Lessons Learned training after each engineering run to staff to demonstrate operational processes that were completed successfully, and solutions for process steps that needed improvements.
• Served as a Person in Plant (PiP) and managed CDMO operations in the cleanroom of phase 3 clinical drug product from cell thaw, bioreactor inoculation, bioreactor harvest, centrifugation, final product vial filling and.
• Provided leadership, guidance, training, and direction to staff in alignment with cGMP requirements at multiple CDMOs.
• Collaborated with area managers to ensure accuracy and adherence to production schedules.

Burlington, MA, US

• Involved with leadership of manufacturing activities at the Carlsbad Viral Vector Manufacturing site.
• Responsible for ensuring the successful GMP manufacture and release of products, promoting a culture of quality and compliance, and continuous improvement.
• Responsible for leading the manufacturing staff working in the facility to meet corporate production goals, as well as influencing related, cross-functional groups to meet these objectives.
• Ensure the facility and equipment is maintained in a cGMP compliant state and ready for use.
• Ensure that the manufacturing facility operates according to cGMP regulations.
• Maintain operations within contracted guidelines in order to successfully produce high quality bulk and finished products.

Burlington, MA, US

• The primary entry point for taking on project responsibility at the Carlsbad site.
• Manufactures cGMP grade Product, with a selection of Biomanufacturing Tech positions used in a supporting function.
• Overall responsibility for the projects assigned.
• Develops custom Master Batch Records, communication with internal and external clients and performs cGMP manufacturing operations.
• Ensures the team is properly prepared and trained and demonstrates good documentation practices in accordance with cGMP standards.
• Operates in a manner that promotes the safety and wellbeing for both employees performing the work, as well as the product being manufactured.

Burlington, MA, US

• Project Planning and execution of cell thaw, cell expansions, and downstream.
• Support in completion of deviations, investigations, corrective and preventive actions.
• Continued training support in GMP technical production.
• Create and update SOPs, and Batch Records as needed.
• Provide instruction and guidance to team members to prevent errors.
• Lead the execution of projects.

St. Louis, MO, US

• Responsible for performing cell culture, buffer, and Media preparation.
• Responsible for membrane clarification, TFF (UFDF) concentration and buffer exchange, column purification.
• Responsible for drafting Batch Production Records and Standard Operating Procedures.
• Responsible for troubleshooting equipment and process failures.
• Recognize common equipment failures and process anomalies.
• Assist in Deviation Investigations, Corrective Action, Preventative Action, and Document Training.

St. Louis, MO, US

• Responsible for biological and chemical evaluation of final products, intermediate products, raw materials and production facilities.
• Analytical Assays; Adenovirus HPLC, Reverse-Phase purity HPLC, Bioburden, Filter Integrity, Osmolality, Total Organic Carbon (TOC), Viral Particle Quantification with UV/OD Spectrophotometer, Glucose/Glutamine YSI.
• Raw Material Identification (ID) Assays via USP methods; Polysorbate ID, Hydrogen Peroxide ID, Acetate ID, Phosphate ID, Edetate Disodium (EDTA) ID, Chloride ID, Carbonate/Bicarbonate ID, Potassium ID, Sodium ID.
• Process in-coming samples in a timely and quality manner.
• Reports results appropriately and efficiently, performs biological and chemical assays.
• Maintaining assay database and provide trends as required.

• Conducted environmental monitoring tasks.
• Responsible for personnel monitoring and gown qualifications.
• Performed dynamic and non-operational monitoring of the manufacturing facility.
• Maintained equipment essential for environmental monitoring.
• Supported Manufacturing operations via QC function.
• Prepared and autoclaved necessary materials prior to environmental monitoring.

New York, NY, US

Austin, US

Bachelor Of Science - Bs, Biomanufacturing, Dean’S Scholar

Associate Of Arts (Aa), Biotechnology Manufacturing Operator

Honors Certificate Of Competence, Biotechnology Manufacturing Operator