BASSAM DAIBES

Hercules, CA 510-932-9466 SUMMARY

Pharmaceutical Quality Control Professional in cGMP environment with extensive experience in diverse areas of Analytical testing and operations from inspection of incoming raw materials through finished Product release. Proven track record of implementing lean process to increase quality and efficiency. Committed to implement best practices, new technologies and procedures to sustain robust processes that increase throughput and reduce cost. CORE COMPETENCIES Project Management Lean Six Sigma DMAIC / Kaizen / 5Ss CCR Management TrackWise/IR/OOS/CAPA Risk Assessment USP/EP/JP Monographs LIMS / SAP/Empower SOP/ IP / RMIP / TRD

bdaibes@gmail.com

PROFESSIONAL HISTORY DEY, L.P, NAPA, CA CHEMIST (07/11 11/11)

Performed daily testing for in-process, Finished Products and stability samples utilizing wide variety of HPLC testing and instrumentation. Review and release test records. BAYER HEALTH CARE, BERKELEY, CA SR. QC ASSOCIATE I (2008- 2011) Led Protein Chemistry Lab for everyday activities including scheduling, reviewing, and release of records. Successfully managed projects to build lean process within the quality control. Supervised team members of projects and led incoming raw materials inspection. Performs review activities for starting materials, in-process and finished product within LIMS and Empower to be released to QA final review and release. Developed and implemented scheduling system to meet customers needed turnaround time (TAT). Combined multiple SOPs into single SOP to streamline document maintenance. Increased the average KPI for Protein Chemistry from < 90% to meet the target of >98%. Chosen to supervise international project management students from UC Berkeley working on a project to increase the quality and efficiencies of incoming raw materials. Redesigned Raw Materials Inspection Plans for Excipient Materials and Primary and Secondary Packaging to meet USP/EP/JP regulations and compliance based on an internal audit complaint. Qualified and certified vendors, manufacturers, and suppliers to use raw materials within the production processes with minimal testing to reduce the cost of production. Partnered with technology development and regulatory affairs to manage the implementation of new nNIR testing methodology for raw materials, obtaining EMEA and Japan approvals. Integrated new Raw Materials Inspection process that reduced the TAT from >20 days to < 10 days. Won third place in a DMAIC competition including over 15 projects. Reduced the testing campaign for Fermenter from 4 times a week to twice a week per risk assessment evaluation, resulting in savings of more than $50K annually and 0.5 FTE. Reduced errors, increased quality and ensured compliance of Raw Material governing documents by combining three SOPs into single Raw Material Inspection Plan (RMIP) . Awarded Premier Circle Award for deliverables and outstanding performance in 2007. Executed the development and implementation of LIMS Master Data and Validation. QC ASSOCIATE SCIENTIST II (2005-2008)

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Hercules, CA

510-932-9466

bdaibes@gmail.com

Responsible for managing CCRs and raw materials master data build up for critical projects, including LIMS implementation (2 years) and Calcium Chloride implementation (1 year). Managed the implementation of LIMS including review of FRS, Master Data and change control requests, as well as revision of more than 200 SOPs. Managed a project that increased raw material quality and decreased costs, saving $100K per year. Managed all CCRs for implementation of SAP for QC/QA. Revised over 60 impacted SOPs. Managed CCR implementation for the relocation and renovation of the QC lab, including all instruments and CTEs. Met deadlines to achieve zero downtime for the move. Tested and reviewed SEC for Protein Chemistry by HPLC for in-process and Final Container. Performed Concentration Desalting assay for Total Protein and Carbohydrate testing. Awarded Premier Circle Award for deliverables and exceeding performance in 2004. QC ASSOCIATE SCIENTIST I (2002-2005) Responsible for managing the stability protocols and reports for all reagents being used in all QC Chemistry labs. Tested incoming samples into Chemistry lab, reviewed and released test records. Performed instrument calibration, managed the inventory of all chemical standard. Responsible for managing the equivalency protocols and reports for method transfer from between instruments. Increased the quality of chemical standards used in the lab to eliminate human errors and non-added values tasks. Managed the reagent stability program to validate the expiration date of reagents after being used as a response to FDA request. FDA approved the response. Managed CCRs for method transfer between instruments and wrote equivalency protocols and reports to ensure compliance and cGMPs are in place. Revised and wrote SOPs and executed validation IQ, PQ, OQ. Reviewed test records for Na, Ca, K, kjeldahl, Osmolality by VP and FP, Karl Fischer, TOC, pH, Conductivity, GC. Performed quarterly instrument calibration such as UV/VIS Spectrophotometer, pH, Balance. SR CHEMICAL ANALYST (1996-2002) Performed daily testing for incoming samples into chemical monitoring labs, raw materials lab, in-process and final container testing lab. Executed validation protocols. Performed routine testing for incoming raw materials and wet chemistry per USP/EP/JP to ensure the materials met requirements. Performed routine testing for in-process samples and final container using a variety of techniques, including UV/VIS, AA for Na/Ca/K, FTIR, Kjeldahl, Osmolality by VP and FP, Karl Fischer, Acetone, PKA, Electrophoresis, GC for Nitrogen, Compressed Air, and Carbon Dioxide. Executed validation protocols rFVIII in order to obtain license from FDA and EMEA.

TECHNICAL SKILLS
Statistical Skills Word/excel/Power Point HPLC, AKTA Electrophoreses AA/GC KF, TLC Training TOC/pH/Conductivity

EDUCATIONAL BACKGROUND
Green Belt Certification (LSS): Bayer Operational Excellence, Berkeley CA Post Graduate Diploma, Education (Masters Degree equivalent): Al-Najah Univ. Nablus, West Bank Bachelor Degree in Science, Chemistry: Bethlehem University Bethlehem, West Bank
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