Summary
Overview
Work History
Education
Skills
Certification
Community Service
Timeline
Generic

CHASE BALLANCE

Summary

As a dynamic program manager, I possess extensive experience in guiding clinical processes from development through to validation and the commercialization of therapeutics. A strategic problem-solver, I leverage my engineering background to address and resolve challenges effectively, influencing and uniting teams to surpass various constraints and achieve project deliverables within the set objectives of time, budget, and quality. I am a trusted communicator, adept at forging partnerships with key stakeholders across various disciplines. My expertise encompasses FDA/EMA guidelines. My core competencies include Commercial Product Launch, cGMP/Regulatory Compliance, Team Leadership, Vendor Agreements/Management, Global Program Management, Continuous Process Improvement, Proposal Development, Product Lifecycle, as well as Process and Equipment Engineering, complemented by New Hire Training/Guidance.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Sr Project Manager (Client Delivery - GMP)

WUXI APP TEC (Contract)
Philadelphia, PA
03.2022 - Current
  • Managed end-to-end development of pharmaceutical products including formulation, clinical supplies, FDA registration, process validation, and commercial launch.
  • Established strong client relationships and ensured effective communication with stakeholders to align project strategy and meet objectives.
  • Play a pivotal role in strategic company decision making by delivering monthly project portfolio updates to CEO and executive management
  • Liaised between senior management, project team members and clients to ensure effective communication throughout the duration of the project.
  • Conducted post-project evaluations to identify improvement opportunities.
  • Streamlined project management practices across department by, including but not limited to, standardizing action item templates utilized by all project managers, developing MS project timeline template utilized by project management team, giving multiple trainings on MS project to project management teams including best practices on how to use MS project timelines to drive projects
  • Developed direct reports' capabilities in project management through comprehensive training programs, delivering constructive feedback to support their advancement and empower them towards achieving their career objectives.
  • Managed numerous internal quality initiative projects and worked alongside Lachman Consulting, renowned in the field of quality, to create a compliance improvement plan that facilitated Renaissance in reaching new heights of quality excellence
  • Ensured effective communication by presenting quality initiative projects to the board of directors
  • Managed the implementation of a Laboratory Information Management System (LIMS) as the Project Lead, ensuring successful integration for company.
  • Identify, effectively communicate, and resolve project issues and risks, as well as develop risk mitigation plans
  • Efficiently managed project planning, execution, and finalization to meet deadlines and scope requirements.
  • Identified business development and add-on sales opportunities as they related to projects.
  • Allocated ~10% of work week towards business development efforts, specifically in the areas of competitive analysis and market research.
  • Analyzed market trends, product sales data, press releases, and clinical trial results to uncover valuable insights relevant to the company.
  • Oversaw budgets for project, tracked expenses, and timelines and communicated with key stakeholders on milestones.
  • Implemented change management processes when issues arose to keep project moving forward and adjust to shifted priorities.

Senior Project Manager (GMP) - Product Development Services (PDS), Pharma Services Global Network

THERMO FISHER SCIENTIFIC
Greenville, NC
05.2019 - 03.2022
  • Successfully managed 20+ Tech transfer projects concurrently while standard project load is 4 projects
  • Resolved all internal and external barriers while managing client expectations, developing new processes as well as overcoming new obstacles that appear during development stage projects
  • Successfully built and maintained client relations that resulted in a 4 year $240million dollar global contract
  • Developed and trained 17 new project management staff as Project management SME including performing 1on1 weekly reviews, weekly Q/A sessions, and providing mentorship as needed
  • Maintained a yearly client revenue of 20+ million
  • Spearheaded Changepoint and Global Track Wise Implementation across Thermofisher Globally
  • Led planning, execution, and close of cross-functional customer projects, collaborating with key stakeholders to introduce new products into facilities, develop processes, develop and qualify analytical methods, and purchase/qualify equipment
  • Cultivated partnerships with clients leading internal sales, technical, and support functional teams
  • Planned and delivered all project stages for products, including sterile drug substance and drug product within a matrix organization
  • Reduced project delays through effective staffing, increasing manufacturing capabilities and developing playbooks to promote risk mitigation strategies
  • Delivered results according to budgets and contract specifications
  • Resolved internal project team issues as they a rose throughout execution and coordination of activities
  • Coached team members during times of stress and staff shortage; training
  • Reviewed communication channels to ensure ongoing open dialogue among team members
  • Gathered user requirements, established scope of implementation, forecasted costs, and identified users and managers for projects to automate hourly reporting processes and track resources in real-time.

Global Project Engineer/Project Manager ISO

ITW MEDICAL
Washington, NC
06.2016 - 05.2019
  • Developed and Implemented Assembly equipment, which included nesting features, part identification, part placement, and installation of secondary components
  • Developed Global Project Timelines using Microsoft Project for internal projects and Smartsheet for cross business projects between sites
  • Part of a new product development team that studied the growing business opportunities and implemented new products that would meet this business
  • Designing products to meet all functional needs, designing and implementing functional, dimensional testing equipment and procedures
  • Determining life cycle testing needed and understanding the customer requirements for this product and its ability to function as intended
  • As well as supporting the process until the complete hand off for production was made
  • Prototyping parts from the design stage until the final stage of the design
  • 3D/2D drawing knowledge to be used by tooling house contractors for fixturing as well as helping with the design of Injection molding Molds to ensure that the product that the molds were producing would work as intended before being created full dimensional layouts included
  • Partnered with Quality assurance to determine requirements needed for product validation and verification
  • As well as determined work instructions and inspection instructions for the product
  • Requested, Purchased and Qualified machinery equipment needed for production purposes
  • This included determining the needs for injection molding machine presses which included the utilities needed for placement as well as determining which services needed to be contracted from outside vendors to get the best ROI that we could get.

Industrial Engineer/Project Manager

Carolina Technical Plastics
New Bern, NC
01.2011 - 01.2016
  • Initiated process layout changes for improved flow and space savings
  • Set up production equipment including IQ/OQ/PQ Process validations
  • Developed Project Plans and Timelines to keep project teams assigned and aligned throughout the project life
  • Testing /inspection station design and build from the ground up
  • Electrical troubleshooting for injection molding machines as well as 3 - 5 axis robots
  • Vision inspection implementation for quality assurance
  • Customer relations
  • Quality analysis for new products in addition to assisting with current quality issues
  • Assisted purchasing department
  • Provided advice on technical purchases and acted as a liaison between purchasing and various technical vendors
  • Provide technical assessments at other parent company locations and vendor sites.

Education

Masters in Business Administration (MBA), Executive Leadership Program -

Liberty University
01.2018

BS in Industrial Technology, Manufacturing Technologies Concentration -

East Carolina University
01.2013

AAS in Electrical Technology, Electronics Technologies -

Beaufort County Community College
01-2011

Skills

  • Process Development
  • Project & Staff Management
  • Site Revenue Forecasting/Management
  • Commercial Product Launch
  • CGMP / Regulatory Compliance
  • Team Leadership
  • Vendor Agreements/Management
  • Continuous Process Improvement
  • Product Lifecycle
  • Process and Equipment Engineering
  • New Hire Training/Guidance
  • Business Development
  • Market research and analysis
  • Project planning, execution, and closure
  • Risk management
  • Client relationship management
  • Cross-functional collaboration
  • Automation programming tools (RSLogics, 5000, Siemens)
  • Microsoft Project
  • SAP
  • Trackwise
  • Sharepoint
  • Changepoint LIMS
  • SLIMs
  • Minitab
  • KPI Tracking
  • Contract Preparation
  • Agile Methodology
  • CSM
  • PMP

Certification

  • CSM (Certified ScrumMaster) Certification
    PMP (Project Management Professional) Certification

Community Service

  • 4H Team Leader
  • Youth Hunt Waterfowl Guide

Timeline

Sr Project Manager (Client Delivery - GMP)

WUXI APP TEC (Contract)
03.2022 - Current

Senior Project Manager (GMP) - Product Development Services (PDS), Pharma Services Global Network

THERMO FISHER SCIENTIFIC
05.2019 - 03.2022

Global Project Engineer/Project Manager ISO

ITW MEDICAL
06.2016 - 05.2019

Industrial Engineer/Project Manager

Carolina Technical Plastics
01.2011 - 01.2016

Masters in Business Administration (MBA), Executive Leadership Program -

Liberty University

BS in Industrial Technology, Manufacturing Technologies Concentration -

East Carolina University

AAS in Electrical Technology, Electronics Technologies -

Beaufort County Community College

Similar Profiles

CREATE PROFILE
CHASE BALLANCE