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Click here or scroll down to respond to this candidateCandidate's Name
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Tel: PHONE NUMBER AVAILABLE EMAIL AVAILABLEPROFESSIONAL SUMMARYResults-oriented analytical/quality control laboratory chemist possessing a strong background of cGMP/GLP compliance with over thirty years of experience in the pharmaceutical industry. Strong knowledge of USP/EP, ICH and FDA requirements for drug applications. Excellent communication skills, project leadership, ability to coach and develop direct reports.WORK EXPERIENCEAAA PHARMACEUTICAL INC., Lumberton, NJ 2015-2020Quality Control SupervisorOversaw laboratory operations and personnel ensuring routine testing, data review and compliance for raw materials (API/excipients), in-process, finished product and stability samples.Responsible for direct hiring, development, and evaluation of personnel.Review/create SOPs, test methods and specifications and ensure compliance with USP/NF, ICH and FDA regulations.Develop, validate, troubleshoot/optimize analytical methods for drug substances and drug products, including writing validation protocols and reports.Ensure proper maintenance, calibration and troubleshooting of equipment.Create IQ/OQ/PQ protocols and reports for equipment qualifications including updates for data acquisition systems (Waters Empower).Participated in audits and qualification of raw material suppliers and outside testing laboratories.Established procedures to ensure raw materials and finished products were compliant for Elemental Impurities (USP <232> & <233>/ICH Q3D (R3)) and Residual Solvents (USP <467>/ICH Q3C(R8)).Ensure proper laboratory deviation investigations regarding OOS, OOT and aberrant results. Guide other chemists in the investigation and documentation process. Author/approve investigation reports and CAPAs.Responsible for training and safety programs for laboratory personnel.Participated as Subject Matter Expert for internal, external and government regulated compliance inspections.DELAVAU, Philadelphia, PA 2013-2014Manager of Quality Control and Analytical Methods DevelopmentManaged a staff of 14 analysts responsible for the release testing and stability of raw materials, OTC (over the counter) and VMS (vitamins, minerals & supplements) products.Provide leadership to team members, guiding them in prioritization of assignments, problem solving, and process clarification with strict adherence to compliance.Laboratory point person for customer complaints, inquiries, audits and regulatory inspections.Review of FDA/USP/EP Compendial updates to ensure that existing methods, specifications (API, excipients, FP, components) and SOPs are compliant and ensure appropriate updates are implemented.Implemented a reduced testing program for raw materials to increase manufacturing efficiency.Established the use of BioLumix and water activity for microbiological testing allowing for faster product release.Oversaw the development/validation of UPLC methods for the conversion from HPLC methods for shorter analysis times and reduction in solvent use.SPI PHARMA, Lewes, Delaware 2012-2013Quality Laboratory ManagerManaged a staff of 15 analysts comprising Analytical, Quality Control and Microbiology for a manufacturer of APIs and Finished Dosage Forms.Schedule daily testing activities for product release and analytical method development, validation and technology transfer.Ensure that departmental quality, compliance, regulatory and safety systems are maintained in accordance with current regulations.Provide guidance, coaching and training on departmental SOPs, USP/EP regulations and ICH guidelines.Worked closely with Production to reduce in process testing through method improvement and harmonization resulting in higher throughput and cost savings.Review and approve SOPs, test methods, calibration procedures, validation protocols and reports, investigations and CAPAs.Candidate's Name
BAXTER HEALTHCARE CORPORATION, Cherry Hill, New Jersey 2008-2011Associate Research Scientist, Technical Services (Consultant through Kelly Services & AllSource)Analytical SME for the Technical Services Department overseeing chemistry related issues for production and QA/QC testing.Liaison between 3rd party contractors and QA/QC responsible for technical transfer of methods and transfer of data for NDA/ANDA filings and for commercial products.Analytical lead for development/validation of methods for grandfathered products. Working closely with contract laboratories to ensure compliance for NDA filings. Reformulation of existing grandfathered products through QbD (Quality by Design/ ICH Q8, Q9 & Q10) from lab-scale batches to demonstration and registration batches.Investigated production problems resulting in OOS/atypical results for numerous parenteral products. Identified CAPA and responsible for ensuring that the findings/improvements were made through Change Control.BAXTER HEALTHCARE CORPORATION, Cherry Hill, New Jersey 2002-2007Manager I, Analytical Research and DevelopmentLed seven-member team to develop and validate analytical test methods for numerous APIs, excipients, and finished product injectables and other pharmaceutical products.Coached and developed diverse team comprised of Ph.D., Masters level and Bachelors degree members. Hired and trained new employees on departmental SOPs and guidances; conducted employee appraisals with development plans for growth.Scheduled analytical activities to support project completion. Activities included method development/validation, stability and product development testing, and transfer of methods to QC.Worked closely with the Regulatory, Pharmacy, Process Development, and Quality Control departments in the preparation of regulatory documents for ANDA filings.Set specifications for APIs, excipients and finished products based on analytical data, and strong knowledge of USP/EP, ICH and FDA requirements.Oversaw the calibration program including the creation of procedures, execution of Instrument Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) of laboratory equipment and 21CFR Part 11 qualification of computer software.ESI-LEDERLE (WYETH PHARMACEUTICALS), Cherry Hill, New Jersey 1995-2001Unit Supervisor, Analytical Research and Development 2000-2001Supervised four-member team in a satellite laboratory for the development of the first generic sterile powder blend antibiotic.Established a satellite laboratory with functions including the purchase of all laboratory equipment, IQ/OQ/PQ of equipment and writing of SOPs and calibration procedures.Successfully led transfer of methods to five different Quality Control laboratories throughout the world.Sr. Scientist, Chemist III, Chemist II, Chemist I, Assoc. Chemist, Staff Chemist, Analytical R & D 1995-2000Developed and validated various analytical methods for injectable drugs including creation of protocols and final reports.Executed troubleshooting for existing QC methods to increase efficiency and to meet current ICH/USP guidelines.Team member of Quantic Group audit for review of SOPs for conformance to corporate SOPs/guidelines as a result of Consent Decree of a sister site.SMITHKLINE BEECHAM PHARMACEUTICALS, KING OF PRUSSIA, PA 1990-1994Associate Scientist, Biomolecular Discovery DepartmentIsolated and identified antineoplastic inhibitors and other active compounds from natural sources for various bioassays which led to several publications in scientific journals. Applied chromatographic techniques to isolate novel compounds and assisted in characterizing these compounds using spectroscopic techniques including LC/MS, NMR, and X-Ray crystallography.Candidate's Name
EDUCATION AND TRAININGTEMPLE UNIVERSITY, Philadelphia, PA B.S., Chemistry 1991Baxter Management Courses: Impact (team building, motivation, communication and personality preferences)TECHNICAL EXPERTISELaboratory Instrumentation:Chromatography: HPLC, UPLC, GC, LC/MS, GPC/SEC, IC, TLCOther instruments: Wyatt, TOC, UV/VIS, AA, FT-IR & NIR Spectroscopy, ICP-MS, ICP-OES, Auto-titration, Viscosity, AquaLab, BioLumixComputer Programs:Data Acquisition Systems: Waters Empower, PE TotalChrom, iTEVA, TiamoSQL*LIMS, isoTrain, Trackwise, Life Cycle Management, QumasMicrosoft: Word, Excel, Power Point |
