*** ***** ****** **. **************, AR *****

acc3mp@r.postjobfree.com 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.

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