Peter M. Lisecki

908-***-**** acr64k@r.postjobfree.com

CERTIFIED MICROBIOLOGY LEADER/CONSULTANT

•Extensive knowledge of GMP’s and GLP’s as well as USP, FDA, ICH and ISO guidelines.

•Represent employer as subject matter expert during governmental, internal and customer audits.

•Strong analytical and problem solving capabilities, with an ability to manage multiple projects.

•Expertise in accessing and improving laboratory functionality, ultimately providing proficient and compliant laboratories.

•Review and approve testing data ensuring integrity and traceability of data as well as performing risk assessment associated with adverse trends including recommendation of corrective actions.

•Ensure that training programs and documentation are in compliance with company policies. Communicate and collaborate with other departments (R&D, Quality Assurance, Production, Engineering, etc.) to ensure all requirements are met in a timely manner.

PROFESSIONAL EXPERIENCE

Contract Microbiology Manager, Sanofi-Pasteur Biologics, Canton Mass 2014

Environmental trending reports, excursions, deviations CAPA’s, guidance to staff.

Microbiology Manager Consultant, Summit Biosciences, Lexington Ky. 2013

•Audit microbiology laboratory in preparation for pre-approval inspection.

Microbiology Remediation Consultant, Genzyme Corp. Allston Landing, Mass 2012 to 2013

•Assure implementation of compliant, operational, and sustainable remedial solutions to consent decree. Review SOP's, and corporate standards to identify and propose remediation activities to address gaps. Perform environmental qualification of facility, including site selection based on risk assessment.

GMP Microbiology Manager, EMSL Analytical, Cinnaminson, NJ 2012

Initiate GMP microbiology laboratory. Create standard operating procedures and protocols for validation of lab equipment and test methods. Focus on sterility,, water and bioburden testing.

Raw Materials Consultant, Microbiology, J & J Consumer Companies Inc., Morris Plains, NJ, 2010 to 2012

•Evaluate and assign risk classification of raw materials and prepare reports.

•Revise/review existing test methods. Utilization of LIMS.

Laboratory Assistant, Raritan Valley Community College, NJ, 2010

•Set up and dismantle lab exercises and prepare stock solutions. Aid professors during classes.

Co Chairman, Opportunity Group, NJ Department of Labor, 2009-2010

•Seek job opportunities for professionals in transition.

Lab Manager, QC Microbiology and Raw Materials (Chemistry), Teva Pharmaceuticals, New Jersey & Florida, 2007-2008

•Started and developed a microbiology laboratory for Northvale facility.

•Initially audited and diligently worked to bring the Florida facility into compliance.

•Conducted laboratory investigations (utilizing LIMS and Trackwise), and implemented CAPA’s.

•Exhibited strong negotiation skills during development of contracts with external vendors.

Lab Manager, QC Microbiology, Par Pharmaceuticals, Spring Valley, NY, 2002 - 2007

•Initiated environmental monitoring programs, ensuring compliance with proposed FDA requirements.

•Spearheaded the effort to validate testing methods, and the laboratory water system.

•Implemented an automated microbial identification system resulting in a more timely release of data.

•Collaborated with QA department performing audits of QC and R&D laboratories.

•Led effort to bring preservative effectiveness testing in-house resulting in annual savings of $25,000.

Teva Pharmaceuticals, New Jersey & Florida, 1998-2002

Lab Manager, QC Microbiology, 1999-2002

Associate Microbiologist II, 1998-1999

•Promoted to Laboratory Manager after working as an associate microbiologist for just six months based on numerous suggestions for departmental improvement and compliance.

•Designed a new microbiology laboratory in Fairfield, NJ.

•Committee member to eliminate unnecessary testing, resulting in an annual savings of $75,000.

•Reviewed and improved testing methods, providing guidance in interpretation of the methods.

•Prepared departmental budgets and monitored expenditures.

Microbiologist, Metuchen Analytical, Contract Laboratory, Edison, NJ, 1997-1998

•Performed microbiological analysis of cosmetics and pharmaceuticals. Collaborated with customers.

Microbiologist, Contractual Scientist Assignments, 1996-1997

Client: Purepac Pharmaceuticals, Elizabeth, NJ

•Conducted bioassays, microbial limits testing and water analysis using microbiological and chemical (Total Organic Carbon and Conductivity) testing.

Client: Ortho Diagnostics, Raritan, NJ

•Performed microbiological testing for the purpose of validating a new water system.

Schering-Plough Pharmaceuticals, Union, NJ, 1990-1996

Analytical Specialist – Microbiology, 1992 -1996

Senior Microbiologist, 1990-1992

•Led the Microbiology Services Lab, including review and approval of testing activities.

•Wrote protocols and validated laboratory equipment including autoclaves, a depyrogenation oven, a lyophilizer and microbial identification systems (VITEK, MIDI).

•Performed microbial identifications utilizing both manual and automated methods.

Clinical Technologist I, II – Microbiology, Lutheran Medical Center, Brooklyn, NY, 1987-1990

•Handled and processed incoming specimens including the isolation and identification of pathogenic microorganisms, as well as manual and automated antimicrobial sensitivity testing.

Teaching Assistant, Touro College Medical School, Huntington, NY, 1987

•Collaborated with professor in developing and preparing microbiology laboratory exercises.

Research Technologist – Microbiology, Long Island Jewish Medical Center, New Hyde Park, NY, 1983-1987

•Examined susceptibility patterns of new antibiotics using MIC, MBC, Kirby-Bauer, and automated methods (Vitek, Abbott MS2). Tested and evaluated microbiological products for FDA approval.

CERTIFICATION, MEMBERSHIP, ACTIVITIES

•Certified Specialist in Consumer and Industrial Microbiology (NRCM)

•American Society for Microbiology and Pharmaceutical Microbiology Forum, Member

•Guest Speaker at CTFA meeting to discuss training in the microbiology laboratory.

EDUCATION

M.A. in Biology, Hofstra University, Uniondale, NY

Thesis: In-vitro effects of antibiotic combinations on the growth kinetics of Pseudomonas maltophilia.

B.A. in Biology, New York University, New York, NY

Contact this candidate