Senior Manager, Manufacturing Sciences, Process Transfer at Biogen

- Process Expert: Owner / Author / Approver of Standard Operating Procedures (SOPs), Batch Records, and Training Documents. Investigate deviations, determine impact, and own effective corrective action plans. Provide real time, on the floor, support of manufacturing during unscheduled downtimes. Mine site data historian (PI Processbook) to assist in troubleshooting and evaluate equipment performance; identify and eliminate process variability. Provide consultation for facility expansion team on equipment and process design. Audit Contract Manufacturing Organizations, generate third-party complaints for defective materials, and assess vendor change notifications. Participate in regulatory audits and assist with responses to regulatory observations.- Filling Suite Team Lead: Serve as liaison between manufacturing and support teams, including Quality Assurance, Automation, Engineering/Maintenance, Validation, and the Deviation team. Identify and lead seasonal projects to increase efficiency, reduce waste, and increase capacity to meet site goals and increasing market commitments. Lead small-scale technical transfers required to support commercial manufacturing. Train equipment operators on process changes. - Key Projects: Dual Serial Filtration - Implement a second sterile product filter in series (compliance requirement). Led team to determine and implement required actions. Served as Project Manager and provided weekly updates to Site Leadership Team to track milestones. Bag to Tank Transfer – Led project to aseptically transfer drug product (manufactured at another site) from a shipping bag to a portable tank for filling (supply chain requirement). Particulate Risk Assessment – Worked as part of a small team to identify the risk of particulates in the final container closure (FDA and EMA regulatory commitment). Assessed every product contact material and unit operation for risk of particulate contribution.

Validation Specialist primarily supporting the fill/finish suite and equipment prep suite in the manufacturing of seasonal flu vaccine. Primary responsibilities include: Provide qualification lifecycle of equipment utilizing an integrated commissioning and qualification approach. Support validation programs such as cleaning, steam sterilization, VHP decontamination, computer systems and aseptic processing Utilize SOPs to develop validation protocols and summary reports Interpret results vs. Acceptance criteria and regulatory guidance utilizing data analysis skills that include the use of intermediate statistical analysis tools Hands on field execution and collection of samples in support of validation studies Coordinate validation activities with the appropriate system owners and other affected departments; integrate validation maintenance activities into site schedules Lead deviation investigations utilizing root cause analysis and investigation tools. Own CAPAs resulting from site deviations Provide training to new team members

 Chosen to defend multiple validation reports to regulatory agencies (FDA, EMA, Korea) Author, execute, and summarize PQ protocols as validation suite lead of thaw/pool/fill activities for live-virus vaccines. Validation/Equipment types: vial washer (CIP), depyrogenation tunnel, cool zone (dry heat sterilization), isolator (VHP decontamination), vial filler (CIP and SIP), and portable tank (virus deactivation) Investigate validation/process deviations to determine root cause and product impact. Perform CAPAs to prevent recurrence Assess the impacts of equipment/process changes to the validated state of the system Assigned to support process validation of multiple products transferred to the Durham site Spearheaded cycle development and qualification of the VHP decontamination cycles of ten sterility testing isolators in the Quality Operations lab Support PQ of lyophilizers, equipment washers, autoclaves, sterility testing isolators, and fixed equipmentBio-sterile Validation Associate Specialist (associate engineer), August 2011 – April 2013 Validation lead of Controlled Temperature Units (CTUs) in the vaccine manufacturing building and warehouse Execute protocols exercising cGMPs to ensure FDA compliance Gather and analyze data to confirm that sterilization, cleaning efficacy, and temperature stability meet protocol validity and acceptance criteria Investigate testing failures with respect to compliance and product impact