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Skilled project and operations administrator wi th multi-department responsibilities that ensure procedural compliance with USDA and corporate standards. Former manager of a pharmaceutical, drug safety Toxic ology Resources team. Ensured GLP compliance with FDA guidelines for data colle ction, interpretation, and reporting. Accomplished team leader, recognized for the development of metrics-based efficiency models. Possesses in-depth knowledg e and experience with capital and operations budgets as well as substantial fami liarity with the administration of human resources applications. EXPERTISE / SKILLS - Conduct, management, and compliance assurance of GLP safety study application s including data collection (documentation) and interpretation, quality assuranc e, reporting, (in preparation for FDA submission). - Data collection systems (Xybion 4.2.2, Xybion Next Gen, ISIS TFR/Tox, Buxco) - Budget development and assessments - Safety study design (multiple species) - Regulatory Toxicology, Reproductive Toxicology, and Safety Pharmacology - Activity coordination, scheduling, and efficiency assessment (for metrics-bas ed assessment programs). Coordination and site development activities with inte rnational sites (Grimston, England; Catania, Italy) - Personnel / Department management and training - IACUC applications (member) - Drug Safety Facility operations - Team / Method Development coordination - Facility Biosafety, emergency operations, and workplace safety applications - Communication Technologies - Anatomical Pathology, Clinical Pathology, and Formulation Preparation procedu res/reporting - Genetic Trait Analysis - Production Quotas and Maintenance - Customer Sales Support/Interactions - Animal care and husbandry processes EXPERIENCE Manager - Production March 2010 - Present Marshall Bioresources; North Rose, NY Overall management responsibilities for several production areas at a US site (assists with oversight of international sites). Works closely with the Directo r of Production to ensure assigned areas carry out production schedules, meet pr ojected quotas, and maintain inventory. Monitors inventory levels and advises m anagement regarding variances to the budget. Identifies, organizes, and manages production statistics. Works with Human Resources to define and administer nec essary vocational programs. Assess and respond (via Sales Department) to custom er feedback. Provides interim on-site management assistance with the developmen t of new international business site in Great Britain (building construction, st affing, security) and supports management efforts for a site in Italy. Works with the veterinary staff to develop work practices and administer directi ves to supervisory staff. Implements corporate initiatives, production plans, a nd policies (including global operations, as needed). Assists with the formulat ion and development of policies and procedures and provides assurances that area s of responsibility are maintained in accordance with USDA requirements. Develo ps and enhances training programs. Manager - Toxicology Resources September 1998 - February 2010 Pfizer (Wyeth Research); Chazy, NY
Management and coordination of technical resources for Regulatory Toxicology, Reproductive Toxicology, and Safety Pharmacology. Responsible for oversight of drug safety study conduct, including in-life activities, data collection/file ma intenance processes, and report review under SOP and GLP guidelines. Ensure com pliance with FDA, USDA, and OSHA standards (No FDA inspection findings through 5 inspections during time held at this position). Authorize schedule projections and coordination of safety studies. Review and approve training procedures and development activities. Authorize applicable SOP procedures and personnel/sch edule activities, including training procedure lesson plans. Plan and authorize department budget spending (equipment; personnel). Oversee preparation and rev iew of personnel development plans. Review and authorize new method development procedures, review safety study desi gn, and authorize documentation development. Conduct and structure coordination activities, and represent departmental concerns with supporting units (animal c are, IACUC, veterinary staff, administration, anatomical pathology, clinical pat hology, Preclinical Quality Assurance, computer support, employee health and ser vices, building support personnel, international site). Lead intra-departmental facility development activities including Biosafety as sessment, facility expansion, FDA site visit preparation, shared technology deve lopment (including data collection and communications systems), procedure/techno logy review, and professional career development. Develop and maintain work met rics analytical programs. No FDA 483 citations during this time. Laboratory Supervisor/Unit Coordinator September 1993 - September 1998 Wyeth Research (Reproductive Toxicology); Chazy, NY Supervision and coordination of laboratory personnel in Reproductive Toxicolog y laboratory. Responsible for oversight of activities pertinent to pharmaceutica l safety study conduct in compliance with SOP and GLP guidelines. Project and c oordinate schedules for reproductive toxicology safety studies. Management of t raining activities for laboratory staff (study procedures; report writing, prepa ration; review of SOP and GLP procedures). Principal investigator for method d evelopment procedures. Review and development of SOPs, protocols, and data colle ction forms. Departmental representative for interaction and coordination of res ponsibilities with supporting units (animal care, IACUC, veterinary staff, admin istration, anatomical pathology, clinical pathology, Preclinical Quality Assuran ce, computer support, and building support personnel). Toxicology Technician Wyeth-Ayerst Research; Chazy, NY November 1990 - September 1993 Ciba-Geigy Corporation; Farmington, CT March 1989 - November 1990 Responsible for conducting Regulatory and Reproductive Toxicology pharmaceutical safety studies under GLP, non-GLP, and SOP guidelines (multiple species). Main tenance of study files, and report writing. Development of compound formulation procedures. Preparation of formulations for dosing administration. Conduct of necropsy (macroscopic examinations), laparotomy, and fetal/embryological examin ation procedures. Photography of laboratory specimens.
EDUCATION Worcester State College, Worcester, MA Bachelor of Science - Biology (1987) Bachelor of Science - History (1987)
Honors: Beta Beta Beta Order of Biology Certifications/Awards: AALAS Laboratory Animal Technologist (LATg) AALAS Certified Manager of Animal Resources (CMAR) AALAS Technologist of the Year - 2004 (Northern Mountain Branch) AFFILIATIONS American Association for Laboratory Animal Science Mid Atlantic Reproductive Toxicology Association Teratology Society Laboratory Animal Managers Association Adjunct Faculty - State University of New York at Delhi RELATED SKILLS Computer: Microsoft Word, Excel, PowerPoint, Human Resources: Personnel management applications International Business: Coordination of International Site Activities