Ryan Schock Email & Phone Number

West Point, Pa

Act as Technical Transfer Leader and product Subject Matter Expert (SME) for live virus lyophilized vaccine products for start-up vaccine manufacturing. Manage product transfer and the associated technical / equipment initiatives in support of vaccine manufacturing unit operations. Manage engineering team tasked with delivery of product transfer of vaccine product(s) to new facility. Additionally provide technical support to cross functional partners via: - Leading technology transfers for sterile products through development and qualification of new processes. - Identification, and implementation of process optimization initiatives to both legacy and new product manufacturing processes. - Acting as technical liaison equipment delivery teams through design, commissioning and qualification activities. - Driving and ensuring collaboration and alignment in process design and process delivery initiatives with sister transfer teams throughout network. - Drafting, Review and/or Approving technical documentation, as necessary. - Executing change control initiatives, as necessary. - Working with cross-functional team to develop building process flows, ways of working, tier structure, etc. - Supporting regulatory inspections by presenting to agencies as product SME, implementing regulatory commitments and/or supporting response writing.- Management of entry level and senior engineers.

West Point, Pa

Act as product Subject Matter Expert (SME) for live virus lyophilized and/or liquid vaccine products and associated manufacturing equipment. Managed critical projects and actions which require cross-department resources. Additionally provide technical support to operations and quality through: - Leading and/or supporting technology transfers for sterile products through development and qualification of new processes. - Identification, and implementation of process optimization initiatives to both legacy and new product manufacturing processes. - Supporting regulatory inspections by presenting to agencies as product SME, implementing regulatory commitments and/or supporting response writing.- The writing and review of technical communications directly impacting the release of product lots.- Draft and review of Standard Operating Procedures, Technical Protocols and Master Batch Records. - Assist in planning and scheduling of activities to facilitate operational changes for the manufacture of LVVs. - Authoring, review and execution of change control packages. - Directly work with Operations personnel to optimize and streamline manufacturing practices where opportunities are present.- Coaching / mentoring entry level engineers

Manage critical projects which require cross-department resources. Projects support the manufacture and release of sterile, lypohilized live virus vaccines through the implementation of supply and regulatory commitments. In addition to project work, provide technical support to operations through: - The writing and review of technical communications directly impacting the release of product lots.- Support the authoring and review of Standard Operating Procedures and Master Batch Records. - Assist in planning and scheduling of activities to facilitate operational changes for the manufacture of LVVs. - Directly work with Operations personnel to optimize and streamline manufacturing practices where opportunities are present.

- Lead Technician responsible for all aspects of Toxicological and Clinical Trial Material for client projects including operation of various equipment and utilities. - Assist in planning and scheduling of activities in the GMP manufacturing area including: client product campaigns, system maintenance and validation, routine environmental sampling and routine cleaning. - Conduct and write Deviation Investigation Resolutions. - Responsible for operations and maintenance of lyophilizers and other production processing equipment and utilities including: autoclave, depyrogenation oven, vial washer, Purified Water system, compressed air system, Nitrogen system and Clean Steam.- Write, execute and review validation protocols and reports and studies including: Installation and Operational Qualifications, Process Validation, Validation Maintenance and Change Controls. - Write, revise, review and train personnel on Standard Operating Procedures. - Executed various qualification and validation protocols for pilot scale equipment and utilities such as lyophilizers, autoclave, depyrogenation oven, vial washer and Purified Water system. - Conducted viable and non-viable environmental monitoring in ISO 4.8, 5, 7, 8 and 9 areas. - Experience encompasses formulation and product and process development of lyophilized parenterals, development and implementation of engineering, calibration and validation protocols.

Bachelor Of Science (Bs), Chemistry

Activities and Societies: Men's Soccer

Education record