Manager Sales

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

**********@***.*** 870-***-****

www.linkedin.com/pub/john-duncan/15/146/b55/

John T Duncan III

Honest Accountable Diligent

Experienced Manager - Regulated Pharmaceuticals

Leads by Example. Trusted execution. Gets things Done.

Collaborative people manager. Deep T echnical k nowledge. Enjoys customer interaction.

Rapidly learns new domains. Business acumen. Comfortable p resenting material. Proven

i nfluencer . Change l eadership experience. Familiar with r egulated environments.

A bility to hit the ground running.

Core Competencies:

Project Management

Hiring / Firing

P&L Review / Alignment

SOP Generation & Review

Current

Professional Experience

Radiation Safety Officer

In ternal Audits

Maintain Calibrations

Monitor Exposures

Leak & Wipe Tests

Liaise with Regulators

I nvolved in developing, implementing, and monitoring Cardinal Health's environmental and

safety programs and policies to ensure compliance with federal, state, and local

environmental, health and safety regulations.

Identified and corrected excessive exposure techniques

Performed initial and annual Radiation Safety Training

Maintained RAM, Wholesale and State Board Licenses

Monitored, secured and retained necessary records

DOT

IATA

NRC

FDA

ALARA

• Facilitated the organization of Cardinal Health Radiation Safety Program at the Memphis site after it's

acquisition from RNP in 2006.

• Direct point of contact at the facility for Tennessee Department of Public Health, Radiologic Health Branch,

Nuclear Regulatory Commission, Department of Commerce, Bureau of Industry and Security, and the

Department of Energy

2012-2013

Area Manager PET Operations

Regulated Pharmaceutical Manufacturing

Direct Reports = 4

Oversaw, developed and integrated multiple Cyclotron facilities and their functional groups.

D irected the production of radiopharmaceuticals in accordance to quality and regulatory

policies, operating procedures and company policies.

Ensure timely manufacture and packaging of products

Develops, t rains 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. In tegrated cGMP philosophy

a t 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

Hi re, t rain, mentor, discipline employees

Promote harmony between Operations and QA

In terpret 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.

Change Control

Validations

Batch Records

Qualifications

Investigations

Helped t ransition this newly acquired site up to Cardinal Health standards in the cGMP

a rea; This included t raining personnel with new procedures, building a quality document

system and implementing materials and equipment standards.

2006-2008

QC Specialist PET Operations OOperations

• CAPA

• NCR

• cGMP

• FDA

• EHS

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 t imely release of product lots

Approve or reject components, containers, closures, in-process material packaging

and labels

Provide t raining for cGMP methods and SOP’s with Operations

2001-2006

Brewing Supervisor

• Production Planning

• 3M BBL’s

• Packaging Coordinator

• Budgets

Maintained overall budget and productivity goals through cost analysis and long

r ange planning

Coordinated brewing shift production, quality control and routine maintenance

Independently led teams of ten to fif teen 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

1998-2001

QA Technologist

• Audits

• ISO

• cGMP

• L I MS

Tested daily samples for chemistry analysis and micro organisms

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

Education

Personality:

Friendly

Positive

Innovative

Disciplined

Masters of Business Administration

Leadership, Finance, & General Management. 3.8 GPA

Bachelor of Science in Chemistry

F ul l Academic Scholarship.

Bachelor of Science in Environmental Health and Safety

Currently in Progress. Expected Graduation 2015.

Contact this candidate