*** ***** ****** **. **************, AR *****
**********@***.*** 870-***-****
John T Duncan III
Honest Accountable Diligent
Operations Manager
Leads by Example. Trusted execution. Gets things Done.
Collaborative people manager. Deep Technical knowledge. Enjoys customer interaction. Rapidly learns
new domains. Business acumen. Comfortable presenting material. Proven influencer. Change
leadership experience. Familiar with regulated environments. Ability to hit the ground running.
Core Competencies:
Project Management
Hiring / Firing
P&L Review / Alignment
SOP Generation & Review
Professional Experience
Oversaw, developed and integrated multiple Cyclotron facilities and their functional groups. Directed the
production of radiopharmaceuticals in accordance to quality and regulatory policies, operating procedures
and company policies.
Current
Area Manager PET Operations
Regulated Pharmaceutical Manufacturing
Direct Reports = 4
Ensure timely manufacture and packaging of products
Develops, trains and motivates employees
Establish and maintain Safety, QA environments and processes
Maintain an effective audit program
Coordinate timely completion of investigations
Generate and implement annual budgets
Evaluate monthly progress on business performance
• FDA
• SOP’s
• cGMP
• QMS
• CAPA
• P&L
• Directed sites with a combined annual sales total upward of $9M and total
dose volume over 50k units. Coordinated with the individual sites and personnel to achieve successful
consistent results to maximize job performance.
• Establish performance goals, development plans, and monitored results. Interview, hire, discipline and
evaluate all employees under direct/indirect supervision.
• Provide direction and employee development for Site Supervisors and support staff including team
building and employee motivation and development.
• Implement and validate protocols to accommodate FDA guidelines and commitments at various sites
around the country.
2008-2012
Site Supervisor PET Operations
Direct Reports = 4
Facility Improvements
Budget Conformance
$2.5M in Sales
Used in depth knowledge to coordinate, oversee and supervise the daily operations at the cyclotron
facility. Managed the site Radiation Safety Program. Integrated cGMP philosophy at the site level and
leveraged the teams’ understanding to build an efficient, successful facility that was compliant with FDA
regulations.
Budgets
Procedures
Radiation Safety
Inventory
Implementation
Prioritization
Oversee day-to-day operations
Manage equipment ordering/maintenance
Hire, train, mentor, discipline employees
Promote harmony between Operations and QA
Interpret and assess customer business needs
• Identified problems and solved them using applied expertise along with defined processes.
• Actively built cross-functional relationships within the company by encouraging participation and
perspectives from all team-members. Worked with the team to promote understanding, support and focus
on operational excellence. Coached and supported subordinates by mentoring and empowering others to
achieve success.
• Successfully integrated SAP into the facility. Coordinated with the project design team, real estate, and
regulatory to help upgrade the manufacturing area. Maintained, managed and controlled inventory,
ordering and receiving.
Helped transition this newly acquired site up to Cardinal Health standards in the cGMP area; This
included training personnel with new procedures, building a quality document system and implementing
materials and equipment standards.
2006-2008
QC Specialist PET Operations
Change Control
Validations
Batch Records
Qualifications
Investigations
Perform technical review of batch records, deviations, OOS, and NCR’s
Perform/assist with internal and external Quality Audits
Participate and review CAPA, Environmental and Alert level reports
Coordinate and facilitate timely release of product lots
Approve or reject components, containers, closures, in-process material packaging and label,
according to specification
Provide training for cGMP methods and SOP’s with Operations
• CAPA
• NCR
• cGMP
• FDA
• EHS
•
2001-2006
Brewing Supervisor
Maintained overall budget and productivity goals through cost analysis and long range planning
Coordinated brewing shift production, quality control and routine maintenance
Independently led teams of ten to fifteen with no supervision in a plant with an annual production
of 3M bbl
Created and maintained a safe working environment by promoting awareness, issuing
comprehensive job safety analysis, and certifications for employees
• Production Planning
• 3M BBL’s
• Packaging Coordinator
• Budgets
•
1998-2001
QA Technologist
Generated and evaluated SOP's and testing procedures
Maintained laboratory instrument calibration and maintenance
Performed weekly cGMP audits throughout the plant
Designed and implemented quarterly testing plan
Directed the Memphis facility inter-plant collaborative audit sample plan
Belgium White brand yeast study and sediment testing initiative
• Audits
• ISO
• cGMP
• LIMS
•
Education
Personality:
Friendly
Positive
Innovative
Disciplined
Masters of Business Administration
Leadership, Finance, & General Management. 3.8 GPA
Bachelor of Science in Chemistry
Full Academic Scholarship.