DANIEL F. WOODWORTH, JR.

416 Belgrade Avenue, Unit 36 (508) 596-0003

West Roxbury, MA 02132 dw9b620e@westpost.net
PROFESSIONAL SUMMARY
Manufacturing professional with 20 years of cGMP experience in an FDA regulated
biotechnology/pharmaceutical facility. Supervised the separation and purificatio
n of batches of human plasma and managed the aseptic filling of vaccines.
KEY SKILLS
a Staff Supervision & Training
a Management of high speed, state-of-the-art Bosch filling line in Class 100 and
100,000 areas.
a Protein Separation and Purification Techniques
a Aseptic Processing

PROFESSIONAL EXPERIENCE
Stop & Shop a" Dedham a" Clerk position (Jan., 2010 to present)
Census Bureau a" Enumerator (Apr.-Jun, 2010)
United Parcel Service a" Driveras helper position (Nov.-Dec. 2009)

MASSACHUSETTS BIOLOGIC LABORATORIES (MBL),

Fill Finish / Manufacturing Supervisor (2006-2007)
a Supervised manufacturing operators, interviewed and wrote performance appraisa
ls and influential in career development planning.
a Planned and supervised media and consistency lots to license the filling opera
tion for Tetanus Diphtheria Vaccine
a Wrote QA documents for the new filling line, including batch records, SOPas an
d Change Reports.
a Headed the team to investigate, install and implement the use of an SMA (steri
lizable microbial atrium) System in the classified sections of the Filling Suite
.
a Was responsible for the supervision of the new Filling Suiteas OQ and PQ. Imp
lemented preventive maintenance program for new filling suite and thereby decrea
sed downtime caused by equipment malfunction.

MBL, Purification Supervisor (1995-2006)

a Supervised personnel on three rotating shifts, involved in hiring process, car

eer development and resolving employee relations issues.
a Supervised the purification of human plasma fractions with continuous-flow cen
trifuges, UF, column, nano & depth filters, and chromatography techniques.
a Supervised the viral inactivation and subsequent sterile filtration to bulk of
final product.
a Annually led each PM (production) shutdown period, working closely with the En
gineer and Facilities Departments.
a Authored and implemented production (mandatory) training programs.
a Initiated, investigated and closed diverse deviation reports with the QA Depar
tment.
a Key player in revision of batch record review process a" worked to improve and
make more efficient the revision system, which was an ongoing process.
MBL, Purification associate (1980-1995)
Performed various protein purification processes under strict cGMP conditions, i
ncluding but not limited to:
1. Continuous flow centrifugation with Sharples AS-16as.
2. UF, DF originally with a Romicon System. In 1991, we upgraded with a Filtron
System, manufactured by Sagitorius Engineering.
3. Depth and cartridge filtration processes.
4. Lyophilization with a Hull exterior condenser unit.
5. Baker Hood sterile connection and sampling, Class 100.
6. Protein precipitations by adjusting solubilites via pH adjustment.
7. CIP of process tanks and work stations the since 1991 performance system upgr
ade, utilizing Allen Bradley ControlView and PanelView software.
8. Buffer, reagent preparations.
9. Batch record and SOP writing.

EDUCATION
STONEHILL COLLEGE
Bachelor of Science, Biology
Boston Latin High School