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• Manage team of engineers monitoring and supporting downstream operations to provide technical and scientific expertise to internal and external stakeholders• Led process characterization studies to improve downstream operations with successful at-scale implementation • Own or review/approve complex process investigations such as product OOS• Own change controls for process changes/improvements• Technical lead for regulatory agency and client audits, including preparation of audit responses

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• Provide CMC support and guidance for product life cycle management• Provide technical leadership and expertise to deviation events, CAPAs and change controls• Interact and collaborate with process development group for small scale studies and material testing

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• Troubleshoot test software and hardware• Incoming and release inspection of raw materials• Formal training and experience in ISO 9001 & 13485 standards and practices

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