VERNON H. STEELE 17 Osborne Terrace Maplewood, New Jersey, 07040 (973) 313-9479 (H); (609) 918-2464 (W) vs10c62e2@westpost.

net PROFESSIONAL SUMMARY Results-oriented professional with many years laboratory experience in the Pharm aceutical and Petrochemical industries. Thorough knowledge of cGMPs, GCPs, regul atory standards and drug development process. Problem solver with excellent anal ytical, instrumentation, management and leadership skills. Recognized as an effe ctive and motivational team player with strong work ethic and commitment to cust omer satisfaction. PROFESSIONAL EXPERIENCE HOVIONE LLC, East Windsor, NJ 2008 -Present Quality Control Manager * Manage/perform QC and Analytical activities associated with raw materials test ing, in-process and final product release (API) testing, method development and validation to ensure project timelines are met. * Prepare, review and/or approve analytical data, methods, method validation pro tocols and reports, specifications, BofA, CofA, OOS investigation/deviation repo rts and IOP's. * Schedule and oversee analysts' weekly/monthly assignments which include instru ment calibration/ maintenance, waste management, housekeeping, chemical inventor y, internal cGMP and safety audits. * Developed and utilize tool to measure QC laboratory productivity/samples turna round times. * Train staff on laboratory work, techniques and instrumentation with emphasis o n cGMPs and efficiency. * Lead deviation and OOS result investigations, initiate CAPA and perform invest igation trending. * Work closely with QA to resolve open investigations and audit responses (elimi nated backlog). * Team lead in handling various projects from initiation to completion. * Hands on experience on LIMS software, SAP, Qstream (CDOC, DocStream, ChangeStr eam and TrainStream) and Empower. STRIDES INC., Somerset, NJ 2007 - 2008 QC Compliance Specialist * Evaluated GMP documents (SOPs, specifications, test methods, protocols, report s, etc.) for compliance gaps against current FDA/ICH guidances and current pharm aceutical industry standards. * Wrote and/or revised SOPs to ensure clarity and compliance with regulation and Standards/Policies. * Reviewed analytical specifications, data, reports, batch records and validatio n protocols/reports for compliance with regulatory requirements and SOPs prior t o release and/or approval. * Reviewed QC and microbiology laboratory investigations and provided support to closure. * Trained employees on cGMPs and compliance related to SOPs and analytical proce dures. * Conducted internal audits and follow-up on audit observations to assure correc tive actions are taken. CELGENE CORPORATION, Summit, NJ 2000 - 2007 Quality Control Manager (2004 - 2007) * Led and managed all in-house and outsourced activities associated with release

, in-process and stability testing of clinical and commercial APIs and finished products. Achieved 100% on time release. * Collaborated with contract manufacturers and Project Managers of clinical supp lies to ensure timelines for project deliverables are met. * Provided quality analytical data during drug development process to support cl inical trials, regulatory filings, product development, scale up and process val idation activities. * Authored/reviewed SOPs and analytical test methods, method transfers/validatio n protocols/reports. * Managed the stability program and contributed to stability reports for annual product review. * Supervised laboratory supervisors including performance objectives/evaluations /development, training and hiring/promotion recommendations. * Provided technical support to vendor issues, including resolution to laborator y deviations. * Established cost and time estimates and budgets for forecasted work on annual or ad hove basis. * Ensured laboratory budget is maintained/managed and updated when appropriate. * Ensured laboratory readiness for and participated in three successful FDA insp ections. VERNON H. STEELE Page Two (973) 313-9479 (H); (609) 918-2464 (W) vs10c62e2@westpost.net CELGENE CORPORATION (Continued) Quality Control Supervisor (2002 - 2004) * Oversaw the day-to-day QC laboratory operations and ensured laboratory complia nce with cGMPs, internal SOPs, DEA and OSHA regulations. * Supervised and trained a staff of 5 chemists with emphasis on cGMP, quality, s afety and teamwork. * Scheduled, tracked and prioritized in coming samples to maintain efficiency an d meet deadlines. * Performed data review and approval of data generated from the QC and Contract Laboratories. * Led OOS and atypical results investigations and initiated corrective/preventiv e action (CAPA). Reduction of OOS results by 30% through counseling, coaching an d training of analysts. Senior QC Analyst (2000 - 2002) * Provided recommendations for improvement of analytical methods and SOP's. * Performed method transfers and provided resolutions to method transfer and met hod validation issues. * Analyzed raw materials, in-process and finished products, clinical and stabili ty samples. ZENITH GOLDLINE PHARMACEUTICALS, Northvale, NJ 1998 - 2000 Senior Chemist * Conducted method and cleaning validations, dissolution and stability testings on solid dosage forms. * Analyzed raw materials, in-process and finished products for residual solvents , assays, content uniformity and impurities/degradants, utilizing GC, HPLC, IC a nd FT-IR and UV/VIS Spectroscopy. * Experience with/ knowledge of method developments, cGMP's, USP/NF and SOP's. EXXON RESEARCH AND ENGINEERING, Linden, NJ 1987 - 1998 Associate Chemist Liquid Chromatography (1994 - 1998) * Analyzed petroleum products utilizing both normal and reverse phase HPLC techn iques. * Performed analyses, product identifications and comparative studies on fuels,

water samples, polymers, lubricants and additives by Gel Permeation Chromatograp hy (GPC) and Ion Chromatography (IC). * Determined molecular weights and molecular weight distributions of polymers by GPC. Gas Chromatography (1990 - 1998) * Characterized polymers, lubricants, deposits and soils utilizing Pyrolysis-GC/ MS/IR. * Analyzed hydrocarbons, fuels, waxes and air by Gas Chromatography (GC). Develo ped GC methods. * Participated in data interpretations, spill identification, report writing, ro und-robin analyses/surveys and client problem solving interactions. Physical Testing and Wet Chemistry (1987 - 1989) * Experienced in ASTM physical characterization standards and titrations dealing with petroleum and petroleum products (e.g. color, acid/base number, gravimetri c analysis, KF) and Quality Assurance. EDUCATION BS, Chemical Engineering, University of Puerto Rico, Mayaguez, PR CERTIFICATION Successful Manager's Leadership Workshop, Personnel Decisions International (PDI ) Pharmaceutical Quality Assurance Certification, NJ Pharmaceutical Quality Contro l Association Laboratory Analyst Training and Certification Program, Drew University and Johns on & Johnson TECHNICAL TRAINING Analytical Test Method Validation in Pharmaceutics, University of Wisconsin-Madi son Reversed-phase HPLC Method Development, Advanza Institute HPLC and Advanced LC, Chromatography Forum of Delaware Valley Capillary Gas Chromatography, Chrompack