Melissa Vasta

Lead complex projects across multiple network sites, overseeing $40M+ in financial packages. Responsible for monitoring project status and facilitating cross-functional meetings, including preparing meeting documentation. Responsible for managing client timelines.

Program Manager II - Catalent - Madison, WI

(2024-08)

• Lead complex projects across multiple network sites, overseeing $40M+ in financial packages.
• Responsible for monitoring project status and facilitating cross-functional meetings, including preparing meeting documentation.
• Responsible for managing client timelines.
• Build and manage relationships with clients and internal teams.
• Manage financial milestones and escalated issues to leadership, as required.
• Lead multiple projects (mAb, mRNA) from early phase through clinical stages.
• Trained four new team members and enhanced onboarding process.
• Developed and maintain the Center of Excellence SharePoint site to streamline digital organization and onboarding training guides within the program management team.
• Request and manage contracts as required.
• Set agendas, facilitate meetings, prepare meeting minutes, and address action items.
• Facilitated the launch of and continue to manage a client data portal.

Project Manager I - Catalent - Madison, WI

(2021-08 - 2024-08)

• Monitored project progress and facilitated both internal and external meetings with cross-functional core project teams; recorded and distributed meeting minutes.
• Oversaw financial milestones and timelines, escalating issues to leadership when appropriate.
• Led multiple drug substance projects spanning various modalities (mAb, mRNA) from early-phase development through GMP, including technology transfer and development programs.
• Initiated scope change orders as required.
• Enhanced processes for seamless PM-to-PM transitions to optimize client experience.
• Developed and maintained a PowerBI Dashboard to monitor key financial KPIs for the project management team.
• Coordinated shipments in collaboration with the shipping team to ensure timely delivery to client sites to meet timelines.

Associate Project Manager - PPD - Middleton, WI

(2018-12 - 2021-08)

• Scheduled and planned stability, quality control, and method development/validation testing to meet both internal and external client timelines and according to changing priorities.
• Managed and facilitated the execution of client contracts working closely with business development, technical staff, and laboratory management according to the scope of work.
• Coordinated internal testing activities across multiple departments (microbiology, physical characterization).
• Utilized project management tracking software to manage client timelines.
• Scheduled and coordinated stability project launches.
• Evaluated monthly revenue projections and quarterly Key Performance Indicators specific to report cycle times.
• Managed project budgets and ensure accurate study billing.
• Coordinated and led external calls with clients and provided agendas and meeting minutes.

Scientist - PPD - Middleton, WI

(2016-11 - 2018-12)

• Managed client analytical method development and validation projects by leading multiple analysts as well as directly executing experiments.
• Developed project timelines and estimated resource requirements to ensure completion of all project tasks by agreed upon deadlines.
• Enhanced project completion efficiency by tracking sample and standard use and by ordering supplies in a timely manner.
• Coordinated activities of multiple departments (sample management, metrology, quality control, and quality assurance) to ensure timely completion of project milestones.
• Designed validation protocols, compiled and reviewed client results, and wrote project status reports.
• Communicated project status updates to clients through biweekly teleconferences.
• Wrote nonconformances, deviations, investigations, and performed root cause analysis.
• Trained in quality control documentation review in accordance with GMPs.
• Trained and mentored three new team members in principles of method validation, documentation, and general lab practices in the GMP environment.

Associate Scientist - PPD - Middleton, WI

(2015-06 - 2016-10)

• Performed a variety of method feasibility, development, and validation studies for complex sample preparations in accordance with GMP, SOPs, FDA, and client specifications.
• Completed greater than 10 method validation studies.
• Collaborated with other team members to ensure timely completion of project milestones.
• Implemented 5S process improvement as part of an initiative to improve operation efficiency.

Master of Science - Soil Science - University of Wisconsin-Madison (2014-08)

Bachelor of Science - Biology with Honors - Lafayette College (2012-05)