Stephanie Belly Wilkins
Owner, PharmaConsult US, Inc
- Bridgewater, New Jersey (Greater New York City Area)
Stephanie Belly Wilkins's Overview
- Owner at PharmaConsult US, Inc
Stephanie Belly Wilkins' Summary
I am seeking to network and grow my business specifically in the area of risk management for cross contamination and operator protection in the pharmaceutical and biotech industries. I am also interested in gaining and sharing knowledge in best business practices, operational excellence and social media.
I am a proven Project Manager with over 26 years of experience in managing and designing facilities with particular emphasis on pharmaceutical facilities. Strengths are in team building, communication and solving complex problems (breaking down complex issues into manageable parts leading to successful solutions), transform/ transfer ideas/ techniques/ initiatives for use in real world situations.
Techniques and programs like Lean Six Sigma, Risk Management, Project Planning and Control.
design and implementation support for containment systems that protect patient, product and worker
Stephanie Belly Wilkins' Experience
Privately Held; 1-10 employees; Pharmaceuticals industry
November 1999 – Present (14 years 11 months)
Manage the day to day as well as the strategic direction for PharmaConsult Us. Duties also include providing global regulatory support to clients in regards to cross contamination and containment. Specialize in Risk Management for cross contamination and operator protection.
Member International Board of Directors
Nonprofit; 51-200 employees; Pharmaceuticals industry
November 2005 – November 2009 (4 years 1 month)
Elected to the ISPE International Board of Directors for two terms where I worked with other Board members to guide the strategic direction of the society. I also was liaison to many of the operating committees to ensure the day to day operations where working in sync and helping to achieve the strategic plans.
Privately Held; 201-500 employees; Architecture & Planning industry
1996 – 1999 (3 years)
Project Manager for A/E design of facilities for toxicology, R&D laboratories and GMP Pilot Plants from concept design through turn over to owner.
Privately Held; 201-500 employees; Civil Engineering industry
1995 – 1996 (1 year)
Privately Held; 51-200 employees; Mechanical or Industrial Engineering industry
1984 – 1994 (10 years)
Gradually increasing responsibilities from HVAC Engineer to Project Manager. Projects included high tech facilities such as data centers for Colonial Penn Insurance Group, Sun Oil and others as well as laboratory facilities for pharmaceutical companies.
Privately Held; 1001-5000 employees; Architecture & Planning industry
1983 – 1984 (1 year)
HVAC Engineer responsible for the design of systems for high tech facilities such as clean rooms for satellite testing and buildings that simulate space motion.
Stephanie Belly Wilkins' Organizations
- January 2012 to Present
Stephanie Belly Wilkins' Skills & Expertise
- Project Management
- Risk Assessment
- Risk Management
- Six Sigma
- Team Building
- Problem Solving
- Quality Management
- Pharmaceutical Industry
- Board of Director experience
- Quality Assurance
- Board of Directors
- Quality System
- Cross-functional Team Leadership
- cross contamination control
- Project Planning
- Program Management
- Cleaning Validation
- Lean Manufacturing
- Technology Transfer
- Regulatory Affairs
- Root Cause Analysis
- Protocol Design
- Process Improvement
- Strategic Planning
- Facilities Management
- Process Engineering
- Continuous Improvement
- Quality Auditing
Stephanie Belly Wilkins' Publications
Authors: Stephanie Belly Wilkins
- Innovations in Pharmaceutical Technology
- December 2010
Risk-Based Manufacture of Pharmaceutical Products – Risk-MaPP – enables manufacturers to justify scientifically that the risk of cross contamination is under control and below acceptable limits in multi-product facilities.
- Pharma QbD
- June 28, 2010
A Q&A with Stephanie Wilkins by Pharma QbD's senior editor, Paul Thomas on the impact ISPE's Risk-MaPP Baseline Guide will have on the biopharma industry.
Authors: Stephanie Belly Wilkins
- Contract Pharma
This article recaps the DC launch session in October 2010 of ISPE's new Baseline Guide, Risk Based Manufacture of Pharmaceutical Products. Comments from FDA and EMA on the document and its applicability to the industry as well as responses to questions from the session are highlighted.
The Use of Acceptable Daily Exposures (ADEs) for Managing the Risk of Cross Contamination in Pharmaceutical Manufacturin
- Pharmaceutical Engineering
- July 2012
This article presents a convincing justification for the use of Acceptable Daily Exposures (ADEs) to scientifically manage the risk of cross contamination in all types of bio/pharmaceutical facilities.
Stephanie Belly Wilkins' Education
Stephanie Belly Wilkins' Additional Information
project management, team building, containment and cross contamination control in pharmaceutical manufacturing, small business management
- Groups and Associations:
- International Society of Pharmaceutical Engineering ISPE Board of Directors 2005- 2009, Chaired many committees led and spoke at many conferences for ISPE
- Honors and Awards:
Chaired the ISPE North American Education Committee which received Committee of the Year in 2001, Chaired the ISPE Risk-MaPP task team which received Committee of the Year in 2010
Contact Stephanie for:
- career opportunities
- consulting offers
- job inquiries
- expertise requests
- business deals
- reference requests
- getting back in touch
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