Project Management Quality Assurance
Resume:
SUMMARY
Executive with over ** years of leadership in the Biotech and Pharmaceutical industry with specific CDMO experience. Proven expertise in aseptic manufacturing, quality assurance, validation, project management, business development, operations, capital expansion, engineering, facilities and client services. Specific experience with development and management of facilities and projects specifically designed to manufacture small molecule drug products, large molecule biologics, vaccines and controlled substances.
Recognized for building high-performing teams, design, project management and oversight of capital expansion strategy and execution for a large sterile injectable CDMO. This includes development and execution of strategic decisions and oversight to drive operational excellence, excellent quality and compliance systems and leading large-scale expansions that also brought record setting revenue growth with EBIDTA of greater than 45%.
PROFESSIONAL EXPERIENCE
Vice President, Capital Expansion, Engineering & Facilities 2024 - Present
Grand River Aseptic Manufacturing, Grand Rapids, MI
New position created to continue oversight specifically for Capital Expansions. This includes focusing on building and providing leadership to the Engineering, Information Technology, Security, EH&S, Validation and Facilities Management Teams. The company has grown to a company that is poised to achieve over $1 Billion in Revenue in the next five years with over 600 employees currently.
Leadership oversight of design of manufacturing plants, manufacturing lines and utility systems that totaled over $300 Million in capital expansion for five large sterile injectable fill lines with advanced aseptic isolator technology to meet all required compliance with cGMPs.
Developed the budget for the proposal that secured a $160 Million-dollar joint investment with the United States Government. This project was under budget and on schedule.
Leading a team of engineers, facilities services and reliability programs to support strategic growth. This allowed the company to grow to 600 people to be ready to support manufacturing revenue up to $1 Billion in the next 5 years
Responsible for ensuring that the facility and equipment are kept up-to-date and in good working order.
Directs Engineering and Maintenance functions.
Specific experience leading operations and systems to support aseptic vial, syringe and cartridge filling.
Led teams responsible in development and support for terminal sterilization, compounding, formulation, and isolator operations.
John Wichelt
Vice President, Capital Expansion, Engineering & Facilities
********@*****.***
Allendale, MI
www.linkedin.com/in/john-wichelt
SKILLS
Capital Expansion
Contracts & Negotiations
Strategic Planning
Aseptic Manufacturing
Quality Assurance
Risk Assessment
Regulatory Compliance
Leadership
Emerging Technologies
Automation and IT
EDUCATION
MBA
University of Illinois
Bachelor of Business Administration (B.B.A.), Project Management
Colorado Technical University
John Wichelt
TECHNICAL SKILLS
Smartsheet and Asana
BIM Planning
Master Control
CMMS
Automation
Advanced Aseptic Technology
AVI And SAVI
Automated Packaging
ACHIEVEMENTS
ISPE Facility of The Year Award
2021
Firm Level Economics: Consumer and Producer Behavior Certificate
University of Illinois
2025
Exploring & Producing Data for Business Decision Making Certificate
University of Illinois
2025
Inferential and Predictive Statistics for Business Certificate
University of Illinois
2025
Managing the Organization Certificate
University of Illinois
2024
Leading Teams: Building Effective Team Cultures Certificate
University of Illinois
2024
PROFESSIONAL EXPERIENCE continued
Vice President, Client Pharmaceutical Services 2014 - 2024
Grand River Aseptic Manufacturing, Grand Rapids, MI
First Vice President position created at the company to oversee client technical transfer projects. This included development and oversight of MSAT, Engineering, Validation, Project Management, and Analytical Technical Service teams in support of new product transfers into the facility. This position grew to oversee project management, information technology, maintenance, engineering and EH&S in support of the first major capital expansion of the company. The company grew from 30 employees to well over 250 employees with revenue increasing form $30 Million ($7 Million EBIDTA) to $200 Million Revenue ($100 Million EBIDTA).
Managed design and build of the company’s first large scale expansion project of a greenfield $60 Million advanced aseptic filling facility that won the ISPE Facility of the Year Award and was chosen by the United States Government to produce one of the first Covid-19 Vaccines.
Managed design and build of the company’s first warehouse, laboratory services and finishing (inspection, labeling and packaging) $50 Million facility to support the aseptic filling facility.
Led the program management of the tech transfer and approval of a Covid-19 vaccine in record time while managing difficult and important health and safety precautions.
Directed program/project management, tech transfer, account services, materials management, and master scheduling functions. Drove client engagement and operational success in support of pharmaceutical partnerships.
Responsible for ensuring that the facility and equipment are kept up-to-date and in good working order.
Directs Engineering and Maintenance functions.
Specific experience leading operations and systems to support aseptic vial, syringe and cartridge filling.
Led teams responsible in development and support for terminal sterilization, compounding, formulation, and isolator operations.
Created cross functional teams within Client Pharmaceutical Services such as MSAT, Validation, Analytical and Microbiology validation and service teams.
Oversaw operational functions such as sterile manufacturing of batches through all finishing operations and drove batch release timing down by over 50% with large customer satisfaction and substantial revenue increase.
Developed and implemented processes and technology such as Asana Smartsheet for project management of tech transfer projects.
Developed and grew a team of project and program managers that oversaw and managed projects for the company that grew to size of 450 employees with revenue of over $150 Million.
John Wichelt
ACHIEVEMENTS
(continued)
Leading Teams: Developing as a Leader Certificate
University of Illinois
2024
Green Belt Certification
REFERENCES
Available upon request
PROFESSIONAL EXPERIENCE continued
Director, Quality Assurance and Regulatory Affairs 2010 - 2014
Grand River Aseptic Manufacturing, Grand Rapids, MI
One of the first four employees hired to startup an aseptic filling CDMO. Develop a team to oversee quality assurance systems and to commission, validation and startup a new manufacturing facility. Grew the company from 4 employees to 30 employees.
Specific experience leading operations and systems to support aseptic vial, syringe and cartridge filling.
Led teams responsible in development and support for terminal sterilization, compounding, formulation, and isolator operations.
Oversaw QA, QC (Analytical and Microbiology), Validation and compliance functions.
Led Regulatory Inspection from the FDA and EMEA.
Led regulatory submissions and internal audits ensuring cGMP compliance.
Developed all new quality and compliance systems and hired the team to manage the quality systems.
Led the team and company to the first three approved commercial products for the company.
Senior Project Manager 2004 - 2010
Pro Pharma Group, Olathe, Kansas
Regional Manager for the great lakes region of the county. Highest sales leader in the company, built customer relationships, strong project teams and successful projects managed to completion. These projects included commissioning, qualification projects and startup and scale up projects for client manufacturing facilities.
Developed the Project Management system and tools for the entire company.
Developed and provided company wide training of project management to ensure consistency through project leads and project managers over all projects.
Developed and managed the Great Lakes region of the company sales from less than $500k to over $7 Million yearly revenue.
CSV Engineer 2003 - 2004
Paladiem Technologies, Chicago, IL
Supported computer system validation efforts for pharmaceutical compliance.
Project Manager 2002 - 2003
Pharm Tech, Lincolnshire, IL
Oversaw multiple pharmaceutical technology transfer and validation initiatives for large pharmaceutical and biotech companies.
Validation Engineer Consultant (Abbott) 2000 - 2001
Raytheon Engineering, Chicago, IL
Executed validation protocols in a GMP manufacturing environment. Assisted in consent decree remediation.
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