John S Dingledine

SUMMARY

A proven effective solutions driven manager with diverse experience in

pharmaceutical drug product, sterile injectable and inhaled insulin

operations including experience in biological regulatory compliance.

Detail oriented, self-motivated individual with a commitment to values-

based leadership and achieving objectives in a manner that is consistent

with leader behaviors. Consistently meet commitments by producing results

on time or ahead of schedule. An advocate of change and recognized by

leadership and peers to creatively think out of the box to accomplish

change.

EMPLOYMENT EXPERIENCE

pFIZER gLOBAL mANUFACTURING, tErre haute, IN

2007 - Present

Manager Quality Systems

Responsible for site activities including but not limited to -

Led regulatory inspections from FDA June '10, July '09, Dec '07, and ISO

Nov '07 no observations

Responsible for semi-finished and finished goods product release

Manage and prepare department budget in line with site budgetary

requirements

Manage site documentation and training

Develop schedule for and oversee internal and external audits

Manage site change control and stability programs

Innovatively created Regulatory Inspection Chest supporting agency

inspections

Drove metrics (Change Control, CAPA and QAR's) toward zero and maintained

metric

Qualification, NDA CBE-30 submission preparation and implementation of new

source (Astur) for Sulbactam API used in Unasyn Injection

Participate in site divestiture and closing activities for cessation of

operations

Supervise 4 Staff Colleagues and 3 OTE Colleagues

Manager Quality Operations Manufacturing (2006-2007)

Support Insulin Spray Dry operations at Terre Haute including co-

development partner Nektar Therapeutics Inc. in resolution of all

investigations related to production including powder release

Identify headcount requirements based on projected volume, hire staff to

support operations

Implement "Release Samples" program by innovatively changing the Pre-

Shipment/Tailgate Sample management process. Resulted in release reduction

from 37 days in 2006 to 2 days in 2007

Implement API inventory program transfer from US (24 month expiry) to EU

(48 month expiry) back to US inventory resulting in scrap avoidance

Led submission activities of Terre Haute spray dried insulin receiving FDA

approval

Streamlined the powder batch record and review process in collaboration

manufacturing

Support qualification for additional Exubera packaging lines, facility,

utilities and labs

$684,000 Volume Based CIP Lab Sample Test Reduction identified for 2008

budget

$165,000 Volume Based CIP Retain Sample Reduction identified for 2008

budget

Averted $12MM scrap of raw insulin following freezer excursion at Nektar

Therapeutics

Supervised 5 Staff Colleagues

Insulin Quality Specialist (2005-2006)

Responsible for Quality support activities for introduction of Exubera into

both EU and US market

Led contractor in design and build of additional in-process laboratory to

support Exubera start up. This included equipment acquisition, development

and execution of IQ, OQ and PQ protocols

Facilitated the development, approval and execution of shipping study

across multiple divisions enabling Terre Haute to distribute Exubera to

Europe meeting established launch dates

Support review and approval of site facility and equipment qualification

activities for Exubera

Support release activities associated with Exubera product to commerce

pfizer global manufacturing lincoln, ne

1995 - 2005

Senior Compliance Professional (2003-2005)

Managed investigations leading to the remediation of customer complaints.

Over 4600 customer complaint backlog reduced within 1 year

Compiled Annual Product Reviews, reduced 8 month backlog within 1 year

Managed the Rapid Response Team supporting the Mutual Recognition Process

regulatory submissions of two biological products. This regulatory process

resulted in simultaneous approval in eighteen European countries for these

two products

Led the Quality Systems Improvement Program (Quantic Project) for

manufacturing systems and support groups conducted at Lincoln. 22 Quality

Systems assessed resulting in the implementation of procedure updates

across site functional areas to enhance regulatory compliance

Coordinate Lincoln responses to EU regulatory inquiries for dossier updates

to 30 different biological products

Completed a development assignment at PGM Terre Haute supporting Exubera

product prior to submission to FDA and EMEA from June 2003 thru September

2004. Provided general quality support for equipment, facility and

processes at Terre Haute. Responsible for Quality oversight of the 12 Hr x

5 Day 2nd Shift that started 7pm supporting PQ submission batches to FDA

and EMEA

Process Assurance Auditor (2001-2003)

Supported manufacturing operations in review of completed production

orders, investigations and change management. Led activities across the

site in QAR and CAPA reduction

Scheduled and executed internal and oversaw external audits of

manufacturing operations, contract manufacturers and or suppliers for

Pfizer products

Quality Assurance Technologist (2000-2001)

Responsibilities included support of manufacturing operations in review of

completed production orders, investigations and change management

Assisted in the conduct of internal audits of site operations

Supervisor Production Development Laboratory (1995-2000)

Responsible for pilot operations ensuring the Production Development

Laboratory managed in full compliance with c-GMP which mirrored all

equipment in Pharmaceutical Operations at pilot scale

Project Manager for the technical transfer of the Paste, Suspension and

Tablet products from the closed Pfizer-London site into Lincoln from pilot

scale through commercial validation. Five Suspension Products 19 sku's,

seven Paste Products 107 sku's, six Tablet Products 18 sku's

Authored and executed validation protocols both pilot laboratory and

commercial scale for bulk and packaging equipment

Conducted product and process scale-up feasibility studies at commercial

scale for product process improvements including minor reformulation

activities of commercial products

Supervised 1 OTE colleague directly and 4 OTE colleagues indirectly

smithkline beecham animal health lincoln, ne

1989 - 1995

Supervisor Formulation Development Laboratory (1989-1995)

Supervised pilot laboratory activities involving Formulation and Production

Development projects

Advised Formulation colleagues at SBAH Philadelphia as to the suitability

of processes under development for eventual scale-up into Lincoln

Managed department supplies operating budget

Author and train colleagues on standard operating procedures

Led reformulation efforts of products requiring regulatory submissions for

vendor initiated changes to API's and Excipients

Supervised 1 OTE colleague directly and 4 OTE colleagues indirectly

NORDEN LABORATORIES lincoln, ne

1977 - 1989

Pharmaceutical Pilot Laboratory (1980-1989)

Positions held in the Product Formulation Development department as

Laboratory Assistant I, II and III Associate Scientist and Assistant

Scientist I and II. Primary duties in progressing positions included minor

reformulation of commercial products

Pharmaceutical Operations (1977-1980)

Positions held in Pharmaceutical operations as manufacturing operator in

the Central Pharmacy, Bulk and Liquid Compounding & Tableting operations

producing tablets, solutions and suspensions

EDUCATION

B.A., Business Administration, Doane College; Lincoln, Nebraska

TRAINING/CERTIFICATION/AWARDS

Certified Quality Auditor, American Society of Quality

Six Sigma Trained Method 2 Green Belt Certified

Pfizer Technology and Innovation Award - Regulatory Inspection Chest

Pfizer Terre Haute Engagement Award

Pfizer Advance Transition Training

References available upon request[pic]

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