Andrew J. Lepage Email & Phone Number

Waltham, MA, US

• Process and technical lead at an experienced viral vector CDMO site for gene and cell therapies
• Technical support for Upstream, Downstream and Drug Product operations, as applicable for client processes
• The team and site support upwards of 8 different client programs at varying lifecycle phases (Technical Transfer, Clinical, PPQ/PV, Commercial)
• Responsible for communication, leadership and alignment on technical, operational and quality topics with the client
• Emphasize superior client experience as evident by receiving the highest client survey ratings within VVS division
• Communication and interaction with Senior Leadership to provide updates on operations and projects

Paris, France, FR

• Manage team of engineers supporting commercial operations to provide technical/scientific expertise and guidance to manufacturing and quality
• Coach and mentor staff through performance reviews and routine 1:1 meetings
• Team collaborates to support multiple drug substance commercial biologics platforms for several internal manufacturing sites, as well as CMO sites
• Lead and support engineering, process validation studies for commercial scale operations
• Prepare, support and participate in internal and external audits
• Team drafts and completes annual product review and process data review reports for data trending and capability

Paris, France, FR

• Implemented change control to execute engineering runs for process improvement initiative to reduce costs and increase yield of drug substance commercial manufacturing operations
• Supported Microfiltration membrane installation and column packing improvement initiatives
• Regulatory Affairs leadership role to assist process-related regulatory filings
• Authored and compiled annual product review report
• Provide technical knowledge and assessment of deviation events, CAPAs and change controls
• Review and approve revisions to manufacturing batch records and procedures

Paris, France, FR

• Implemented change control for downstream processing of new Mammalian cell line bioreactors to increase commercial production capacity
• Developed membrane and resin lifetime Process Validation protocols for filtration and chromatography unit operations
• Generated process trend templates used for daily monitoring of manufacturing process data
• Own and support process-related CAPAs, deviations and investigations by providing technical knowledge and assessment in collaboration with cross functional teams
• Daily and off-hour support of continuous manufacturing operations

• Analysis of small molecule drug substance manufacturing process data, operating parameters, set- points and design space
• Participate in batch record preparation and review, process performance analysis and support of scale-up and tech transfer activities for CMO site
• Review project, study or controlled documentation and development reports
• Work with Quality group on controlled documents and initiatives such as deviations, OOS and investigations
• Maintain and manage Technical Operations documentation management system

Norwood, MA, US

• Responsible for the definition, documentation and performance of product testing
• Perform product validation and conformance
• Identify and resolve functional product issues
• Produce and distribute production reports
• Maintain product databases and test spreadsheets
• Coordinate with manufacturing personnel and supervise test technician

Rosebank, Gauteng, ZA

• Attend and participate in daily production and monthly process meetings
• Daily interactions with department management and production personnel
• Produce monthly statistical process report
• Develop and edit Excel macros for data gathering and organizing