PROFILE:

 Experienced quality operations leader with a history of successful regulatory and customer audits.

 Subject matter expert in a variety of pharmaceutical technologies.

 Lean Sigma expert with a track record of designing cGMP compliant efficient quality systems.

Microbiological Environments

Owner 2016 - Present

A microbiology laboratory specializing in environmental monitoring and providing laboratory support for life science industries.

Atlas Analytical Inc.

Founder, Co-owner 2015 – Present

An analytical laboratory offering rapid microbiology testing to life science industry, including but not limited to compounding pharmacies, biotechnology, generic and cosmetic companies.

 Designed quality system and wrote all requisite SOP’s.

 Hired and trained staff. Oversaw purchase and qualification of all equipment.

 Responsible for all aspects of business development and financial direction of business.

FOCUS Scientific, Inc. 2013 - Present

Principle Consultant

Owner of cGMP consulting company focused on training, auditing, and consultation. Designing and implementing cGMP systems for Compounding Pharmacies, Medical Device Manufacturers, early phase Biotech companies. Proven track record in delivering compliant and effective

 cGMP training

 Equipment validation

 Environmental monitoring programs

SGS Life Science Services

General Manager, NJ Laboratory 2004- 2013

Responsible for technical, regulatory and business leadership of multimillion dollar pharmaceutical contract research organization.

 Managed microbiology, chemistry, quality assurance and customer service staff.

 Consulted with clients through every stage of drug development – pre-clinical through release testing.

 Led site through 483 free FDA audits

 Developed environmental monitoring programs for several clients.

 Authored microbiology, stability, and extractable and leachable protocols for pharmaceutical clients.

 In Q2 2010, served as Interim General Manager for SGS Canada (100 FTE) and in Q3 2010 served as interim General Manager for SGS Illinois (90 FTE) – while still performing duties of General Manager SGS New Jersey. Restructured both organizations for enhanced quality and profitability, recruited new leadership.

 Integrated M-Scan Laboratory acquisition to SGS network.

 Designed 5,000K laboratory renovation. Improved work flow of microbiology and chemistry laboratories.

ANTHONY GRILLI Page 2

 Worked with other GM’s in Europe and Asia to harmonize processes.

Celsis Laboratory Group, Edison, NJ 1999-2003

Vice President/General Manager

Managed and directed multi-million dollar contract laboratory service organization providing chemistry, microbiology, and toxicology testing to the pharmaceutical and health industries.

 Lead both New Jersey and St. Louis Divisions to growth in revenue and profit. Supervised hiring, training, development, and management of 150 employees.

 Focused on enhancing both regulatory and customer quality of services offered by both divisions.

 Developed microbiology and chemistry method validation protocols.

 Hosted FDA audits resulting in no 483 observations.

Director Microbiology 1996-1999

Provided technical leadership for microbiologists at the NJ Division. Responsibilities included P&L ownership, quality system maintenance and enforcement, customer satisfaction, client consultation, employee motivation and training, and management reporting.

 Collaborated with Celsis International on bioluminescent technology applications, specifically developing protocols, exploring applications, validating methods.

 Expanded the laboratory’s service profile and trained analysts in the new methods, including: Ames mutagenicity test, kinetic endotoxin assays, antibacterial soap assays, disinfectant tests, and in vitro toxicity tests.

 Assisted in the design of a new microbiology laboratory, including Class 100 Sterility Suite and Media Prep lab. Managed move of entire operation to new facility with no down time. Developed Master Plan and then supervised the revalidation of microbiology equipment in compliance with cGMP regulations.

SGS US Testing Company, Fairfield, NJ 1993 – 1996

Manager Microbiology

Provided technical leadership for staff of microbiologists at serving pharmaceutical, cosmetic, specialty chemical industries.

 Increased Microbiology Department’s annual revenue 20% annually over three years through organic growth developed by client focus and business development of new service profiles.

 Served as SGS North American representative for SGS International HACCP Development Team in Geneva, Switzerland.

 Assisted in the design of new laboratory. Managed move of entire Microbiology operation with no down time.

Nabisco Food Group, East Hanover, NJ 1987 – 1993

Staff Microbiologist

 Supported in-house product development groups and plant quality assurance personnel with microbiological analyses and studies.

Gibraltar Laboratory, Fairfield, NJ 1983 - 1987

Microbiologist

 Prepared media and conducted all matter of microbiology tests for life science industry.

 USP, AOAC, EP, BP, CTFA, ASTM tests

EDUCATION:

University of Medicine and Dentistry New Jersey (UMDNJ), New Brunswick, NJ

Master of Science Degree: Microbiology

Rutgers University, Newark, NJ

“Quality by Design and Extractable and Leachable Testing” BioPharm Int’l. 28(2) 34-47 February 2015.

“Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance” International Journal of Pharmacy Compounding 19(1): 30 – 37. January 2015

“Microbiology & Compounding Pharmacies”,  Contract Pharma, September, 2013

“Excipient Testing in a Global Environment”, Contract Pharma, September 2009.

“Harmonization of USP Microbial Limits Methods:  Are You Ready?”, Contract Pharma,  July/August 2006.

“Water Validation:  Demystifying the Microbiology”,  Contract Pharma,  Volume  6, No. 8; October 2004.

“Escherichia coli:  Classic Indicator of Potential Problems”  Pharmaceutical & Cosmetic Quality  Volume 2 Number 2; March/April 1998.

“Staphylococcus aureus:  Emergence of a Superbug”  Pharmaceutical & Cosmetic Quality, Volume 2 Issue 7; December 1997.

“Calibration in a cGMP Laboratory: a HACCP Approach”,  Journal of cGMP Compliance,   Volume 1 Number 4;  July 1997.