Laboratory Manager, GLP Compliant Laboratory, Pre-Clinical Tox/Path
Resume:
RICHARD A. RODRIGUEZ
Newton, NJ 07860
C: 973-***-****
m1zisx@r.postjobfree.com
http://www.linkedin.com/in/richardrodriguez964
Dedicated scientist and manager with over twenty-one years experience performing and overseeing research and laboratory procedures involving necropsy and histology in pre-clinical GLP setting in the pharmaceutical industry. HTL Certification. Expertise in GLP compliance, preparation and revision of Standard Operational Procedures (SOPs) and Laboratory Procedures (LPs). Specific experience performing and training small and large animal necropsy and routine histology; small animal handling; instrument validation-IQ/OQ test script prep and execution; MS Word, PowerPoint, Excel, PATHDATA.
PROFESSIONAL EXPERIENCE
MERCK RESEARCH LABORATORIES (formerly Schering-Plough) Lafayette and Summit, NJ
2009 - 2011
Scientist 2 – Anatomic Pathology – Necropsy Lead
• Directed Anatomic Pathology technical staff, allocated resources and coordinated study activities for GLP and Discovery studies for both in-house and in other company laboratories.
• Monitored quality and provided training as necessary, ensuring the highest quality work output.
• Ensured compliance with FDA and GLP regulations, as well as adherence to all company SOPs, LPs, policies, guidelines and good documentation practices.
• Prepared, reviewed and revised the functional area SOPs and LPs.
• Supported and addressed GLP compliance initiatives for the department. Participated in and reviewed departmental Quality Assurance (QA) audits.
• Reviewed Toxicology study protocols, Pathology reports and QA audits.
• Participated in Toxicology protocol review sessions with all involved departments to assist the Toxicology Study Director in the finalization of the study protocols.
• Collaborated with toxicology study directors to develop rapid collection techniques for pancreas, nerve, heart and other tissues using various fixation and freezing techniques for biomarker and other special collections.
• Assisted toxicology technicians in handling rodents during necropsies and terminal sacrifices.
• Worked with scientists from other areas within Merck on various toxicology, biomarker and discovery projects.
• Completed Six Sigma training for Yellow Belt certification.
• Prepared and trained staff on numerous study specific procedures as an interim effort to combine procedures from the merged companies in order to stay in compliance with SOPs at all sites.
• Actively participated on numerous global SOP harmonization work teams, identified best practices from the merged companies, and helped to draft and finalize the combined procedures.
• Maintained the Anatomic Pathology Equipment List, provided final updates through the Lafayette closure. Updated the Summit Laboratory Equipment List with additions from Lafayette, and then finalized the list for the Summit closure.
SCHERING-PLOUGH RESEARCH INSTITUTE (SPRI) Lafayette, NJ 2006 – 2009
Scientist 2 – Anatomic Pathology, Toxicology and Pathology Scientific Operations – Supervisor
• Supervised and evaluated performance of up to seven Anatomic Pathology technicians.
• Responsible for the management of technical staff, including compliance, training, resource allocation and coordination of study activities of a team of up to 30.
• Monitored the quality of work performed within Anatomic Pathology and provided training for the Anatomic Pathology segment of all studies.
• Ensured that FDA and GLP regulations were adhered to in those areas of responsibility, and that the work produced was of the highest quality.
• Prepared documents for equipment purchases for the department, and completed equipment qualifications/validations including preparation and execution of test scripts.
• Reviewed protocols, Pathology reports and QA audits.
• Prepared, reviewed and revised the functional area SOPs and LPs.
• Collaborated with scientists from other areas within Schering-Plough.
• Active participant in FDA inspections. Laboratory passed every FDA review from 2000-2010.
• Coordinated a site-wide Technician Appreciation Week with other department managers each year for 2007-2009.
• Supervised the decommissioning of instruments and laboratories of the Lafayette Anatomic Pathology Department during the 2009 closure of the site.
• Instituted the documentation and tracking of laboratory reagent lot numbers in collaboration with the other lab supervisors across the Summit and Lafayette sites.
• Participated in two steering committees that reported to senior management: Development and execution of the Master Qualification Plan for the division, and the SOP committee.
SCHERING-PLOUGH RESEARCH INSTITUTE (SPRI), Lafayette, NJ
2001 – 2006
Scientist I – Anatomic Pathology – Necropsy/Histology
• Trained and mentored staff in Necropsy and Histology.
• Reviewed, revised and composed LPs and SOPs.
• Performed necropsy and histology on GLP pre-clinical studies.
• Functioned as a necropsy and histology study monitor: ensured staff adhered to SOPs and protocols; prepared study materials; lead team to study completion from the necropsy of the animals to the processing of tissues to slides, and submittal to pathologists.
• Performed special stains when requested.
• Maintained inventory of necropsy supplies.
SCHERING-PLOUGH RESEARCH INSTITUTE (SPRI), Lafayette, NJ
1995 – 2001
Associate Scientist – Necropsy/Histology
• Performed necropsy and histology on GLP pre-clinical studies.
• Functioned as a necropsy and histology study monitor: ensured staff adhered to SOPs and protocols; prepared study materials; lead team to study completion from the necropsy of the animals to the processing of tissues to slides, and submittal to pathologists.
• Performed special stains when requested.
SCHERING-PLOUGH RESEARCH INSTITUTE (SPRI), Lafayette, NJ
1990 – 1994
Assistant Scientist II Necropsy/Histology
• Performed necropsy and histology on GLP pre-clinical studies.
• Functioned as a necropsy and histology study monitor: ensured staff adhered to SOPs and protocols; prepared study materials; lead team to study completion from the necropsy of the animals to the processing of tissues to slides, and submittal to pathologists.
IMPATH LABORATORIES, New York, NY 1990
Immunohistotechnologist
• Performed ER/PR staining protocol on human cases, as well as other immunohistochemical stains
AMERICAN HEALTH FOUNDATION, Valhalla, NY 1987 – 1990
Histology Technician
• Assisted scientific investigators and pathologists in preparing specimens on microscope slides for preventive cancer and disease research
• Archived slides and specimens
• Maintained laboratory supply and ethanol inventory
• Co authored Standard Operating Procedures for histology laboratory
• Trained new technicians in histology lab procedures.
EDUCATION
Masters of Science, Biology, Fairleigh Dickinson University, Madison, NJ, 2002
Bachelor of Science, Biology, Fordham University, Bronx, New York, 1986
PROFESSIONAL MEMBERSHIPS
American Society of Clinical Pathologists (ASCP)
National Society for Histotechnology (NSH)
New Jersey Society for Histotechnology (NJSH)
CERTIFICATIONS
Histotechnologist (HTL) ASCP Board of Registry Certification
Merck Six Sigma Yellow Belt
CONTINUING EDUCATION
Essentials of Management Workshop, Right Management Consultants, SPRI, Kenilworth, NJ
SOP Writing Training Course, Skills Plus International, SPRI, Madison, NJ
Training 101: All the Basics Workshop, Langevin Learning Services, SPRI, Cranford, NJ
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