Project management and program management for a gene editing company (Client: Metagenomi)
• Strong project management leadership skills including, critical ability to coordinate and balance multiple projects in a time-sensitive environment, under pressure, and meeting deadlines
• Leverage SmartSheet software for project scheduling and dashboards
• Manages IT Project Portfolio and provide regular dashboard updates
• Program management for post-implementation of a ELN cloud-based application, Benchling
• GxP Readiness: Leading and managing end-to-end implementation of a Computerized Maintenance Management System (CMMS).
• Collaborate with cross-functional teams to gather requirements, identify key stakeholders, and establish project goals and objectives.
• Monitor project progress, tracked milestones, and reported key performance indicators to senior management, ensuring alignment with organizational objectives.
• Business Systems: Collaborated with internal stakeholders to under

Sr. Project Manager
• Managed fast paced IT implementation projects (Cybersecurity, ELN - Benchling, Financial Systems)
• Managed CQV Pilot Plant project for gene editing (client: Metagenomi). Total project budget $573K
• Managed Cx facilities/utilities project for genetics medicine company (client: 4D Molecular Therapeutics). Total project budget $328K
• Responsible for on-site team resource management
• Leveraged SmartSheet software for project scheduling and dashboards
• Provided Earned Value Analysis (EVA) for project controls
Client Partner
• Responsible for on-site team leadership and client relationship management of the dedicated accounts
• Conducted regular check-ins with client managers at the dedicated accounts for overall service satisfaction and outlook on future project
• Provided oversight on all client purchase orders and monthly progress reports
• Authored proposals and change orders for client project support
• Managed large project bids in organizing prop

• Responsible for the leadership of technical account managers and regional client teams, fully managing client accounts, regional sales, and providing selected senior-level consulting support to clients
• Maintained healthy client relationships, management of escalation issues
• Collaborated and supported business development initiatives to obtain new clients in geographic area
• Generated sales leads within the assigned region and establish teams
• Developed new business with existing clients and identify areas of improvement to meet client needs
• Organized and implement programs for business operations
• Leveraged Pipedrive for Sales CRM and Lever for ATS
• Coordinated and facilitated project kick off for awarded RFP projects
• Forecast and tracked key account metrics (quarterly revenue results and annual forecasts)
• Participated and supported ISPE industry events throughout the year

• Responsible for on-site team leadership and client relationship management of the dedicated accounts
• Conducted regular check-ins with client managers at the dedicated accounts for overall service satisfaction and outlook on future project
• Provided oversight on all client purchase orders and monthly progress reports
• Authored proposals and change orders for client project support
• Managed large project bids in organizing proposal generation (review RFP, coordinating RFIs, assembling resources and SMEs, cost estimation)
• Mentored employees and provided career development growth
• Supported recruitment activities such as resume review, interviews and generation of offer letters

• Managed GMP and non-GMP capital project for CMO (client: Boehringer-Ingelheim)
• GMP - Commissioning and Qualification of Secondary Packaging Area including carton packaging machine, leaflet barcode verifier, serialization machine. Total project budget 25MM+
• GMP - Commissioning and Qualification of QC Analytical Instruments. Total project budget 300K+
• Non-GMP - Tenant Improvement – Office Space project
• Non-GMP - Process Science Lab renovation including installation of new utilities and new lab equipment
• Non-GMP - Process Science new analytical instruments projects
• GMP & Non-GMP Lab Move projects
• GMP - Feasibility studies for new autoclave replacements
• Developed project charters, project execution plans (PEP) for project initiation
• Presented project funding requests to senior leadership team
• Created project schedules with MS Project. Leveraged schedule baseline to track schedule progress
• Managed change management process throughout project lifecycle
• E

• Performed Manufacturing equipment qualification consisting of developing, authoring, and executing IOPQ of tube welder, tube sealers, cell counter and cell analyzers
• Performed QC analytical equipment qualification consisting of reviewing and verifying vendor IOPQ protocol execution and developed and executed IOPQ protocols for supplemental testing to meet URS requirements
• Ensured manufacturing and QC analytical equipment computerized systems are 21CFR Part 11 compliant by developing supplemental qualification testing of system configurations and functionalities for user management (access control), password policy, user and data traceability (electronic signature and records, dates, time stamps, and audit trail), data integrity (data files are stored and retrieved from a secured database and is original)
• Supported CIP Optimization (DeltaV) – Recipe Qualification
• Supported new recipe cleaning verification and cleaning validation

• Supported Process Validation efforts for Continued Process Verification (CPV)
• Completed the Technical Professional Develop Program (TPDP) - Validation, Manufacturing Science and Technology, Maintenance & Calibration