DAVID A. AGOSTINELLI

** **** *****

Lock Haven, Pennsylvania 17745

570-***-****

aca4ge@r.postjobfree.com

SUMMARY

Proven quality control laboratory supervisor/manager with 28 years of total

experience in the laboratory, 15 years in supervisory/management roles,

including experience working in the pharmaceutical industry and for ISO-

certified companies. Effective in troubleshooting and resolving quality

control issues. Demonstrated ability to lead diversified teams.

EMPLOYMENT HISTORY

> 2007- 2013 MPI Research, Inc.

State College, Pennsylvania

2008 - 2013 Manager, Quality Control

2007 - 2008 Senior Research Chemist

o Supervised and performed the quality control review of LC-MS/MS, GC-

MS, and ICP-MS analytical data packages for FDA GLP and EPA GLP

studies.

o Maintained GLP compliance in a contract preclinical

pharmaceutical/niche environmental analytical laboratory.

o Wrote, reviewed, and approved standard operating procedures and

analytical methods.

o Reviewed and approved laboratory investigation reports.

o Served as the site Quality Assurance Officer for non-GLP environmental

analysis.

> 2003- 2007 Grace Davison Discovery Sciences (formerly Alltech

Associates, Inc.)

State College, Pennsylvania

2004 - 2007 QA/QC Supervisor

2003 - 2004 Chemist

o Supervised the quality control testing of HPLC and SPE media,

capillary GC columns, and drug, hydrocarbon, and fatty acid standards.

o Served as ISO Coordinator for the site

o Performed the quality control testing of drug, hydrocarbon, and fatty

acid standards.

> 2002 - 2003 Alpharma USPD Inc.

Baltimore, Maryland

2002 - 2003 Supervisor, QC Laboratory

o Supervised the quality control testing of raw material, finished

product, and stability samples.

o Maintained cGMP compliance in a major pharmaceutical company

analytical laboratory under FDA Consent Decree conditions.

o Wrote laboratory investigation reports.

o Reviewed and approved analytical data packets.

> 1998 - 2001 Omnicare Pharmaceutics, Inc. (formerly IBAH Pharmaceutics,

Inc.)

Fort Washington, Pennsylvania

2000 - 2001 Manager, Stability and Quality Control Testing

1998 - 2000 Supervisor, Manufacturing Support

1998 Group Leader, Manufacturing Support

o Maintained cGMP compliance in the analytical laboratory of a contract

clinical supplies manufacturer/packager.

DAVID A. AGOSTINELLI

14 Park Drive

Lock Haven, Pennsylvania 17745

570-***-****

aca4ge@r.postjobfree.com

EMPLOYMENT HISTORY (continued)

o Managed all analytical testing in support of manufacturing and

packaging, including raw material, finished product, and stability

testing, and cleaning validations.

o Wrote and approved laboratory investigation reports.

o Wrote and approved standard operating procedures and analytical test

methods.

o Reviewed and approved analytical data packets.

o Reviewed client contracts and established analytical pricing.

o Represented the analytical department in FDA and client audits.

o Audited third-party contract laboratories for compliance and

capabilities.

> 1993 - 1998 Warner-Lambert Company (now Johnson and Johnson)

Lititz, Pennsylvania

1997 - 1998 Analyst Supervisor, Mouthwash Testing

1994 - 1997 Analyst Supervisor, Stability Testing

1994 - 1994 Analyst

1993 - 1994 Associate Analyst

o Maintained cGMP compliance in a major pharmaceutical company

analytical laboratory under partial FDA Consent Decree conditions.

o Supervised the testing of raw materials, finished products, and

stability samples for the global supply of Listerine mouthwashes.

o Supervised the testing of raw material, finished product, stability,

and complaint samples for pharmaceuticals and consumer products.

o Wrote and approved laboratory investigation reports.

o Reviewed and approved analytical data packets.

o Performed routine testing of raw materials, finished products, and

stability samples.

> 1990 - 1993 Supelco, Inc.

Bellefonte, Pennsylvania

1992 - 1993 Chemist, HPLC Research & Development

1991 - 1992 Chemist, Custom Standards

1990 - 1991 Chemist, Quality Control

o Operated custom chemical standard segment of business, including

costing and pricing, devising manufacturing and testing procedures,

and providing technical information to customers.

o Standardized testing procedures for chemical standards, and

coordinated the computerization of those procedures.

o Performed routine testing of environmental standards and

chromatographic supplies.

EDUCATION

o Received Bachelor of Arts degree in Biology with a minor in Chemistry

from the University of Delaware in 1985.

o Graduated from Williamsport Area High School in Williamsport,

Pennsylvania, in 1979.

o Certified as a Lean Six Sigma Green Belt.

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