Accomplished and reliable MS degreed Analytical Chemist offering years of experi
ence and education to the organization. Focusing primarily on Staff Development, Laboratory Efficiency, Raw Material, In-Process and Finished goods release, Ana lytical Methods Development and Laboratory Quality Improvement Measures. PROFESSIONAL EXPERIENCE
Biotest Pharmaceuticals, Boca FL 2008-2009
Biopharmaceuticals - Monoclonal Antibodies and Plasma Products - 250 employees o n site Director of Quality Laboratories * Managed work flow and development of 30 Med techs and analysts (BS, MS, PhD's) ; 3 direct reports. * Supported 13 US Plasma sites, daily on-site manufacturing operation and produc t transfer support from EU. * Responsible for: Staff development, methods transfers, methods development, d aily QC testing, Raw material testing (standard USP/EP methods, purity, etc.), i n-process and production support and project management of Mab scale up from Dre ieich Germany; Review, assistance, troubleshooting of methods when applicable. * Assistance, teaching and mentoring support for development chemists primarily with separation science methods of analysis (HPLC, GC, Elisa, SDS-Page, etc.). Baxter Healthcare Corporation, LA CA 2003-2006 Biopharmaceuticals - Plasma, albumin, blood bank, coagulation etc. products Manager II, Quality Laboratories * Managed work flow and development of 50 Med techs and Chemists (BS, MS, PhD's) ; 5 direct reports. * Quality Control and Analytical support for daily on-site 24/7 manufacturing op eration. * Troubleshooting bench issues during daily analysis of production material. * Responsible for: Staff development, project management, daily QC testing, Raw material, in-process and production support under US regulatory compliance. * 21 CFR 640 compliant laboratories (participation in two FDA and monthly custo mer audits) * Utilized six sigma tools for cycle time reduction projects. Lonza Biologics, Portsmouth NH 2002-2003 Biopharmaceuticals - Monoclonal antibodies, scale up, manufacturing and producti on support Director of Quality Control Operations * Managed work flow and development of 75 Med techs and Chemists (BS, MS, PhD's) 24/7; 5 direct reports. * Responsible for the LIMS deployment, Raw Materials quality, stability, Environ mental Monitoring programs and daily 24/7 manufacturing Quality Control and Anal ytical support. * 21 CFR 316 compliant laboratories (participation in one FDA and multiple custo mer audits. * Managed the successful relocation of all laboratories from 4500 sq.ft. to 17,0 00 sq. ft. without adding additional staff (example 6 HPLC's to 18 HPLC's; 8 GC' s to 12 GC's). Genzyme Diagnostics, San Carlos CA 2001-2002 Medical Device - manufacture of clinical and personal use diagnostic test kits Quality Control Manager * Managed work flow and development of 5 Quality Control Analysts (BS). * Responsible for 21 CFR 809 compliant laboratory. * Managed stability programs, proficiency studies, raw material and finished pro duct release, equipment and instrument validations, customer and FDA laboratory audits. DSM Catalytica Pharmaceuticals, Palo Alto CA 1999-2001 Active Pharmaceutical Ingredients (API) manufacture Quality Control Manager * Managed work flow and development of 15 professional chemists (BS, MS) and 1 I S supervisor in a 21 CFR Part 11 compliant 24/7 Quality Control laboratory. * Directed implementation and maintenance of site Statistical Process Control (S PC) and Statistical Quality Control (SQC) program. * Reduced permanent and temporary staff turnover by 90% in 6 months through effe ctive coaching and counseling. BetzDearborn-GE, Trevose PA 1993-1999 Specialty Chemicals; Emulsion and solution Polymers Research Scientist * Managed work flow and development of 4 employees; 3 Chemists (BS, PhD) and one off site 24/7Laboratory Supervisor. * Managed quality control, corporate technical services, and Corp contact for th ree international satellite labs (International travel, methods development and tech transfer to supporting laboratories). * Promoted from Scientist to Sr. Scientist then to Research Scientist over the c ourse of approximately 6 years. * Responsible for implementation of Laboratory ISO 9001/14000 compliance program s. * Provided QC support for corporate R&D organic synthesis and polymer chemists,. Huls America, Specialty Chemicals; Silicones and Silanes 1990-1993 Analytical Development Chemist Responsible for Raw Materials, in-process and finished goods methods development and release testing. EDUCATION, PROFESSIONAL DEVELOPMENT & PROFESSIONAL AFFILIATIONS MS Chemistry Instrumental analytical concentration 1996 St. Joseph's University BS Chemistry 1989 Eastern University Taught non-majors chemistry lab to Hahnemann nursing students during undergradua te studies Intern for Esschem Corporation; Dental Monomers and polymers as Analytical Techn ician Project Management skills includes: Six Sigma/Lean Mfg support, Global Methods D evelopment and Tech Transfer, Scale Up support, Implementation and maintenance o f SPC/SQC programs, etc.