Stephen A. Winstead Jr., CSSYB *** Longleaf Pines Dr. Phone: (910)

***-****

Raeford, NC 28376 Email:

acb735@r.postjobfree.com

EDUCATION AND CERTIFICATIONS:

. University of Massachusetts (Lowell, MA) - B.S., Biological Science

. Six Sigma (Yellow Belt) - University of NC / Pfizer

SKILLS:

Leadership / Management:

0. Managing production and aseptic filling within a USDA regulated vaccine

production facility. (Pfizer / Zoetis, Inovocox)

0. Shift supervision within a FDA regulated vaccine production environment

(Pfizer, Prevnar).

0. 8 years experience managing a staff of up to 7 direct and 40 indirect

reports in both small and large companies.

0. 8 years experience in quality department, production, and laboratory

management (Chemistry, microbiology, & phage).

0. Six-sigma, TQM, and DMAIC problem solving utilization and

implementation in daily work activities and investigations.

0. Computer programs including: DELTA-V, SAP, M.S. Office (Access, Excel,

Word, Outlook), MS Project, Windows (7, Vista, XP, 2000), RAPID, LIMS

(ELEMENT, Q-LIMS, and LIMDA).

0. Authoring, issuing and approving Certificates of Analysis and product

release approvals. (3 years)

0. Creating MS Access databases and Excel spreadsheets for needed

calculations and predictive modeling. (12 years)

0. Writing and revising SOP's, investigations, CAPAs, change controls,

validation reports, and supervisory reports.(9 years)

0. Leading contamination investigations to successful conclusions in

aseptic processes and operations. (8 years exp.)

0. Hands-on auditing experience (HACCP, cGMP, aseptic design, and vendor

qualification) (6 years exp.)

Regulatory:

0. In-depth knowledge of and experience with cGMP compliant FDA and USDA

regulated manufacturing facilities.

0. Knowledge of and experience with BioTSCA, NIH, and EPA guidelines for

large-scale production of genetically modified BSL-1 and BSL-2

microorganisms. (6 years)

0. Performing federally required annual biosafety training in a BioTSCA

environment. (4 years)

Fermentation Plant Startup Experience:

0. Qualification, evaluation, and performance of CIP and SIP protocols for

stationary and portable vessels from 10L to 500k gallon reactors,

including spray ball coverage studies utilizing riboflavin. (8 years)

0. Designing, equipping, validating, and managing QC, phage, and

microbiology laboratories. (6 years).

0. 4 green-field fermentation plant startups successfully completed in 6

years (2 aerobic, 2 anaerobic).

0. Authoring all SOP's to operate and validate efficient microbiology,

phage, and QC chemistry labs (6 years)

0. Expertise in bacterial and yeast fermentation (6 years), and industrial

microbiology up to 500k gallons (8 years)

Quality & Laboratory Competencies:

0. Filter integrity testing and program qualification (WIT, diffusion,

retention testing (ASTM F838))

0. HPLC, GC, Karl Fisher, XRF, wet chemistry, and hydrometry (5 years

exp.)

0. Statistical Process Control (SPC) and Six Sigma familiarization with

incorporation into existing manufacturing environments along with

startup laboratories (7 years exp.)

0. 10 years of industrial and pharmaceutical QA/QC microbiology

experience.

0. Extensive knowledge of fermentation, aseptic design and processing,

aseptic filling, and filtration technologies. (9 years)

0. Writing and performing equipment, process, and sterility validation

protocols. (8 years exp.)

0. Analyzing and trending process and statistical data; developing SPC

charts. (6 years exp.)

0. Certified in Dupont "STOP" training and "Behavioral Observation"

training. (4 years)

0. Developing and performing sterility and limit programs for water (WFI,

USP, DI, city, and process, per USP 61 & 62), raw material feeds, and

compressed air. (8 years exp.)

Environmental Monitoring:

0. Total and viable particulate monitoring of clean rooms (class 100, 1k,

10k, and 100k), class 100 hoods, biological safety cabinets, and

compressed air systems. (8 years)

0. Environmental monitoring using RCS sampler, Met-One particle counters,

rodac plates, settling plates, slit-to-agar machines and air-

impingement devices. (7 years)

0. Development of monitoring programs for glass fibers, viable/non-viable

particles, bactero-phage, GMO, and mold (4 years)

EMPLOYEMENT HISTORY;

10/2011 - Present: (10/11 - 12/12) Pfizer (Sanford, NC): Quality

Engineer and Production Supervisor

(02/12 - Present) Pfizer Animal Health / Zoetis (Maxton,

NC): Production Supervisor

I was hired by Pfizer in October, 2011 as a quality engineer to assist with

the optimization of the manufacturing process for their Prevnar vaccine

line in anticipation of the technology transfer to their production

facility in Grange Castle, Ireland at the end of FY2012.

As a quality engineer I accomplished the following:

. Championing safety in all forms and working with site leaders and EH&S

to promote and improves site safety. This culminated in being selected

to represent Pfizer at the Carolina Star safety conference in

Greensboro, NC.

. Identifying and Optimizing inefficiencies in aseptic design, processing

procedures, and variations in SOP execution.

. Worked with diverse groups to identify and update key processing steps

with SPC charts and other tools to decrease variation, decrease cycle

time, and decrease potential regulatory compliance and licensing

exposures while increasing the accuracy of batch record execution.

. Worked with corporate quality to update quality agreements with key

suppliers and contract laboratories.

. Organizing and running both Kiazen events with diverse teams to solve

challenges and optimize the manufacturing process.

. Evaluated, identified and corrected deficiencies within the SIP system

for certain stationary and portable vessels used in aseptic vaccine

manufacturing.

In October, 2012 I was promoted to production supervisor for Shift-B of the

Prevnar manufacturing facility where I supervised 8 direct reports until

January, 2013 when production of the Prevnar vaccine was transferred to

Ireland.

Following the outsourcing of Prevnar manufacturing to Ireland I was

transferred to the Pfizer's Animal Health Division where I was promoted to

the position of team leader overseeing the production of the Inovocox

vaccine line in Pfizer's Maxton, NC vaccine plant.

As the production team lead overseeing Inovocox vaccine production I have

accomplished the following:

. Championing safety initiatives and ensuring that the production team

members were appropriately provisioned with all necessary PPE.

. Investigating and remediating a recurrent mold contamination that had

plagued the manufacturing facility for the prior 3 years.

. Investigating, remediating, and optimizing Tangential Flow Filtration

(TFF) skid cleaning procedures that were limiting throughput and

contributing to yield loss.

. Introducing real-time DMAIC and six-sigma problem solving to the shop

floor.

. Authoring and performing qualification protocols for the implementation

of a Westfalia centrifuge, Palltronic Flowstar XC filter integrity

tester, and the elimination of redundant manufacturing procedures to

increase throughput, improve sterility, decrease scrap, decrease

operational costs, and maximize opportunities to recapture production

efficiencies.

. Assisting other departments by providing statistical data analysis to

assist them in their investigations.

. Working with Procurement to establish a raw material and vendor

qualification program.

. Drafting qualification and implementation protocols featuring six-sigma

centered statistical analysis and risk analysis for utilities and

process water modifications, the upgrading of aseptic filling suite

equipment, and modifications to processing equipment and tanks.

. Championing a transition to increasingly stringent documentation, data

collection, process change control adherence, and aseptic practices.

. Revising and editing production batch records, SOP's, media outlines,

policies, and other documents relative to the daily production

operations in the manufacture of Inovocox vaccine.

. Worked with engineering to evaluate, modify, and qualify CIP recipe

modifications for all portable and stationary vessels used in

manufacturing.

08/ 2005 - 05/2011: New Fermentation Plant Quality Department Creation,

Startup, and Management.

I completed four green-field startups of fermentation plants in six years.

At each plant I was retained early into the construction phase to create,

equip, validate, staff and manage the laboratories; write all quality and

environmental monitoring procedures; hire, train, and manage the laboratory

technicians, and serving as the quality department manger (plants 2 and 4),

and laboratory supervisor (plants 1 - 4). After the plants were completed

I was responsible for quality department and fermentation optimization

(plants 1,2, and 4).

Please see "ADDENDUM 1" for additional details about and accomplishments at

each startup.

1) 08/2005 - 12/2007: Dupont, Tate & Lyle Bioproducts (Loudon, TN) -

Manger of the Microbiology and Phage Laboratories, Plant

Microbiologist, and Assistant biosafety officer. (Plant idled 09/07)

a. Aerobic fermentation utilizing a GMO E. coli K12 to ferment 1,3-

Propanediol.

2) 01/2008 - 07/2008: Greater Ohio Ethanol (Lima, OH) - Quality Manager

(Plant Closed 07/08)

a. 54MM Gal/yr Dry-Grind ethanol facility consisting of six 500k

gallon anaerobic fermentors, and two 25,000 gallon aerobic

fermentors utilizing Saccharomyces cerevisiae.

3) 07/2008 - 11/2009: ADM Polymer (Clinton, IA) - Microbiology Lab

Manager (Contract through startup phase only to 11/09. Plant idled)

a. Aerobic fermentation facility utilizing a GMO E. coli K12 to

ferment Mirel biodegradable plastic.

4) 11/2009 - 05/2011: Clean Burn Fuels (Raeford, NC) - Quality Manager

(Plant Closed 03/11)

a. 60MM Gal/yr Dry-Grind ethanol facility consisting of six 550k

gallon anaerobic fermentors, and two 50,000 gallon aerobic

fermentors utilizing Saccharomyces cerevisiae.

4/2003 - 5/2005: Millipore, Inc. (Jaffrey, NH): - Quality Control

Microbiologist II

. Filter Quality and Integrity Testing (hydrophobic and hydrophilic)

. Bacterial retention testing of finished filter units utilizing B.

diminuta per ASTM F838.

. Sterility and limit testing of process, WFI, and RO water per USP 61 & 62

. Microbiological lab support duties including: media preparation,

equipment validation, etc.

. Environmental monitoring of total and viable particles, glass fibers and

compressed air in class 1,000 clean rooms.

. Writing and revising SOP's, initiating out-of-spec reports, and writing

and performing V&Q protocols on equipment and processes as needed.

. Designing and validated a cooling system for the retention test apparatus

to enable the creation of a second shift in the laboratory.

5/2001 - 9/2002: Biotech contract worker in the Greater-Boston Area:

. 2/2002 -9/2002: Bristol Myers Squibb, Inc. (Billerica, MA) - Quality

Control Microbiologist (6 month contract)

. 11/2001 -2/2002: Macrochem, Inc. (Lexington, MA): Trans-Dermal Laboratory

Technician (3 month contract)

. 5/2001 - 11/2001: Charles River Laboratories (Wilmington, MA): Transgenic

Technician (6 month contract)

ADDENDUM 1

ADDITIONAL DETAILS ABOUT EACH FERMENTATION PLANT STARTUP

11/09 - 05/11 Clean Burn Fuels, LLC (Startup #4 - Out of Business)

(Raeford, NC)

Quality Manager (Startup #4)

Clean Burn Fuels (CBF) was the first corn-to-ethanol plant in North

Carolina. When I arrived at CBF the plant was 60% mechanically complete

but lacked a quality department, QC lab, lab equipment, and all

associated procedures and standards. CBF is the fourth green-field

fermentation startup I have worked with.

My accomplishments at Clean Burn Fuels, LLC include:

EQUIPMENT / LAB/QUALITY:

. Specified and purchased all lab equipment, instrumentation, and

consumables.

. Set up and validated all lab equipment, including HPLC, GC, Karl

Fischer, Moisture Analyzers, IC chromatograph (Metrohm 880 IC Plus),

titration burettes, centrifuge, microscope, etc.

. Wrote all quality department SOP's (approximately 60 in total).

. Designed and drafted all quality department forms, data sheets, and

databases.

. Designed and wrote MS Access (Ver. 2007) databases to collect all

fermentation, quality, calibration, equipment, SOP, MSDS, and

production data.

. Issue and approve all certificates of analysis for ethanol, wet cake,

DDGs, and syrup. Wrote and designed the COA procedure and system for

CBF.

. Maintain consumable inventories and order materials, as needed, to

ensure seamless operation of the laboratory.

. Specified, purchased, and set up the grain receiving/testing lab

equipment.

. Oversee the performance of all quality-related and mycotoxin testing

for incoming grain and outgoing animal feed products.

LEADERSHIP / MANAGEMENT:

. Wrote and managed the quality department budget to ensure budgetary

compliance.

. Trained and supervise 40 production operators in their use of quality

department equipment and procedures.

. Prepare, analyze and disseminate daily, weekly, monthly, and quarterly

quality department data reports for use by other members of management

and the board of directors.

. Created Statistical Process Control (SPC) charts and calculators

(excel based) for all calculations required to operate the plant, then

trained 40 operators in their use.

REGULATORY / ENVIRONMENTAL:

. Wrote the company chemical hygiene plan to comply with 29 CFR 1910.

. Ensured compliance with all applicable regulations including ASTM

D5501, BATFE, EPA and NC-DENR regulations.

. Authored the company's spill/release testing and mitigation programs

to ensure appropriate compliance and documentation with all EPA,

state, and local regulations.

. Oversee the monitoring and mitigation of all uncontained releases, and

ensure that all necessary testing and documentation are performed.

. Monitor the on-site retention pond on an ongoing basis to ensure

compliance with all EPA and NC-DENR regulations.

7/08 - 11/09 ADM Polymer, Co. (Startup #3 -

Contract) (Clinton, IA)

Microbiology Laboratory Supervisor (Startup Phase)

I was retained by ADM Polymer to build and manage the microbiology lab

through the startup phase. ADM Polymer is a fermentation plant that

utilizes a genetically modified E. coli to ferment Mirel biodegradable

plastic. The microbiology department was built to ensure compliance with

all applicable regulations under 21 CFR 110/111, and USP guidelines.

My accomplishments at ADM Polymer include:

1. Training and managing a staff of 4-6 full-time microbiology laboratory

technicians through the startup.

2. Authoring all microbiology SOP's to operate and validate the

microbiology and fermentation laboratory.

3. Contamination isolation, identification, mitigation and recurrence

prevention in five 15,000-gallon and ten 100,000-gallon fermentation

vessels.

4. Analyzing fermentation data for trends and fermentation health, as

well as developing SPC charts and control sheets.

5. Authoring the bioburden/sterility monitoring procedures and programs

for the following systems: DI water, phage, soil, clean rooms,

dextrose feed stock, cooling tower water, environmental monitoring,

compressed air, and all sterile ingredient addition systems.

6. Authoring validation protocols for all steam sterilizers, clean rooms

(class 1k, 10k, and 100k), bioreactors, biological safety cabinets,

and class 100 laminar flow hoods.

7. Specifying and acquiring all laboratory equipment, consumables,

furniture, and supplies necessary to fully equip the microbiology lab

and clean rooms.

8. Authoring and overseeing preventative maintenance programs for the lab

equipment, steam autoclaves, clean rooms, and hoods.

9. Authoring the Chemical Hygiene Plan for ADM Polymer pursuant to 29 CFR

1910.1450.

1/2/08 - 7/25/08 Greater Ohio Ethanol, LLC (Startup #2 - Out of Business)

(Lima, OH)

Quality Manager and Continuous Improvement Manager

Greater Ohio Ethanol (GOE) was a startup 54 MM gallon/yr dry-mill ethanol

plant where I was employed to create and manage the quality department

and quality control lab, including all associated SOP's, procedures,

policies, budgets, and structure within the corporation. As quality

manager I oversaw all matters pertaining to or having the ability to

affect the quality of final products. Unfortunately, GOE went out of

business due to a financial downturn within the ethanol industry.

My accomplishments at Greater Ohio Ethanol include:

1. Specifying, purchasing, setting up and validating all chemistry

laboratory equipment.

2. Writing all quality department SOP's and environmental monitoring

protocols.

3. Managing, hiring, training, and scheduling a staff of 3 laboratory

technicians on a day-to-day basis.

4. Ensured compliance with all applicable regulations including ASTM

D5501, BATFE, EPA and OH-DNR regulations.

5. Investigating, identifying, and correcting all process contaminations

in the plant.

6. Managing and overseeing all fermentations and matters of aseptic

technique or sampling within the plant.

7. Establishing and maintaining an annual budget for the quality

department.

8/2005 - 12/2007 Dupont, Tate & Lyle Bioproducts, LLC. (Startup #1 - Plant

idled 9/07) (Loudon, TN)

Microbiology Lab Supervisor / Phage Lab Supervisor / Plant Fermentation

Microbiologist

I served as the plant microbiologist, microbiology lab supervisor, and

phage lab supervisor at Dupont, Tate & Lyle Bioproducts, LLC (DT&LB)

starting in August, 2005. Prior to my arrival at DT&LB the company did

not have any completed laboratories, lab/validation SOP's, or

microbiology lab personnel.

My accomplishments at Dupont, Tate &Lyle Bioproducts include:

1. Managing a staff of up to 6 laboratory technicians including hiring,

training, scheduling, and career mentoring.

2. Actively monitoring all fermentations for contamination and

microbiological growth dynamics.

3. Leading all contamination investigations within the company.

4. Creating all aseptic validation protocols for all fermentors, tanks,

addition systems, and headers.

5. I designed, implemented, and maintained all environmental monitoring

and plant sanitation programs for bacterio-phage, airborne

particulates, GMO, soil, bioburden/sterility of raw materials, waste

stream monitoring, and bioscrubber GMO discharge.

6. Working closely with a colleague in Dupont I co-developed and tested a

new, proprietary rapid phage detection protocol capable of detecting

environmental bacterio-phage in ultra-low concentrations.

7. Authoring all microbiology and phage lab SOP's, data sheets and

databases needed to successfully operate both laboratories.

8. Maintained and oversaw the TSCA inventory of culture (biocatalyst)

used to initiate the fermentation processes. I grew the biocatalyst

inoculum that was used to inoculate all fermentations.

Contact this candidate