FAROKH FAROKH-MEHR (M.Sc.)

** ****** ***** **-** Toronto, Ontario M2K 0B3

416-***-**** ac30kx@r.postjobfree.com

SENIOR ANALYTICAL CHEMIST LAB MANAGER

Multitalented senior professional in analytical chemistry with more than 15 years of experience in the biotechnology and pharmaceuticals industries. Demonstrated history as an exceptional leader coordinating laboratory setup, operations, calibration and validation on analytical instrumentation, software, related data review, data integrity, HPLC data auditing checks, sample preparation procedures, representative injection repeatability, recovery, consistent integration, method transfer, developing stability protocols, stress testing forced degradation and impurity profiles, precision (RSD), ruggedness, robustness system suitability tests and specification, project management for major clients. Extensive knowledge of analytical processes, procedures, methodologies, and technologies, leveraged to ensure accuracy and outstanding performance throughout all stages of test development and execution following 21CFR 211 guidelines, OOS and OOT investigations. Dedicated to achieving excellent standards of quality control, coordinating all aspects of regulatory and standards compliance, laboratory safety, Laboratory data management storage and archiving using LIMS, equipment maintenance, and repair. Proven track record of implementing optimized processes and procedures that resulted in improvements to efficiency, productivity, safety, and cost control.

Analytical Chemistry, Laboratory Management, Test Development & Execution, Project Management

Protocol Development, Equipment Installation & Maintenance, Process Improvements, Workplace Safety

Quality Control Chromatography (Analytical / Preparative, Chiral) Troubleshooting GLP, Laboratory Standards, Quantitative & Qualitative Analysis, Spectroscopic Analysis, Team Leadership

PROFESSIONAL EXPERIENCE: Regulatory Compliance Associates Inc. 2017 Project: PharMEDium, Sugarland, Texas, USA As a Support Chemist working in the lab utilizing analysis of sterile liquid injectable APIs such as Oxytocin, Epinephrine, Norepinephrine, and Phenylephrine using UPLC/MS (QDa) and PDA detectors

Validant, San Francisco, California, 2015-2016 Consultant, working in Analytical Chemistry field for Pharmaceutical Industry Project: Patheon Pharmaceutical, Ferentino, Italy.

Data review, data integrity, audit trail review: the review on computer systems of the data "history" to ensure attributable, readable, contextual, original and accurate data.

Deviations and Lab OOS opening and management through the Trackwise system. Reports writing for QC Lab and QA department, analytical chemistry SME.

Data review of stability program and protocols including Check Points (CP), sampling range (Time limit within CP samples collected from different storage conditions for the analysis), Matrixing and Bracketing.

Technology transfer specifying methods, tests to be performed and specification for each CP. Preparation of stability Protocols and condition to be applied upon agreement with the client, QC/QA compliance, and OOS investigations.

Preparation of stability Protocols and condition to be applied upon agreement with the client, QC/QA compliance, and OOS investigations.

Checking the accuracy of results and information in the stability report, proper storage of the samples once they have been delivered to their laboratory/working group and correct application of the procedure.

Terms and stability plans (long-term, intermediate, accelerated) and storage conditions. Stability charts flows and documentary, stability managed by LIMS. QC Data review of the raw material, intermediate and finished products, data integrity, and audit trails, OOS investigations, Trackwise.

To ensure traceability of printouts and test results and confirm batch results, workbooks/test record entries, reagent solution, logbook entries, usage of Oracle (SQL, LIMS V5) and Empower II, III software etc.

Review of HPLC/GC chromatograms to assure appropriate method set up, running and integration parameter, injection sequence, data handling.

Deviation from GMP with respect to data integrity monitoring through client's global quality management system and escalation process.

TORONTO RESEARCH CHEMICALS, Toronto, Ontario, 2001-2014

Supervisor, Quality Control & Analytical Laboratories

Directed launch and management of an independent global laboratory qualification program, including defining all protocols and procedures such as ISO17025 and required GMP, GLP, ICH guidelines.

Implemented necessary tools using automation and state of art analytical instruments for a high-throughput analytical laboratory.

Coordinated method development and validation on HPLC for variety of samples as API and their byproducts, impurity profiles, metabolites, and isomers which were synthesized in small-scale in-house for USP and several ongoing projects by world-renowned pharmaceutical industries.

Performed HPLC and GC method development on APIs under stability studies with forced degradation using high pressure and high temperature and data review.

Maintained testing schedules under very fast pace work demand.

Prepared all documentation needed for calibration and validation of existing analytical instruments for internal and external audits.

Maintained prompt schedule on refill and service requirement for NMR (refill of LN2, LHe), and monthly overall shimming adjustments), LC-MS/MS (cleaning and changing sample cones, the metal capillary for ESI, and fused silica capillary for APCI probes).

Evaluated, diagnosed, troubleshot, and repaired serious equipment issues, working with vendors and third party providers on service calls and post-repair compliance as needed.

Delivered a comprehensive laboratory setup including environmental and layout issues for NMR systems HPLCs, LC-MS / MS and GC systems and their compliance with IQ, OQ, PQ protocols.

Monitored and upheld all classical wet chemical analyses updated including KF and volumetric titrations using potentiometric detection with the variety of Ion-Selective Electrodes

Stored and archived corporate and regulatory requirements, GMP, GLP and validation, master files, instrument operation manuals, instruments maintenance logbooks, reference standards.

Assured a high standard of quality and performance while reducing costs associated with equipment replacement by managing all routine major repair and service procedures.

Implemented measures designed to reduce downtime and improve organizational efficiency

Elevated staff competencies and ensured seamless adoption of new equipment, instruments, and hardware /software by coordinating all aspects of implementation and user training.

Circumvented liabilities in the laboratory environment by authoring and implementing preventative maintenance plans and schedules.

Preserved data integrity and continuity by coordinating electronic data backup and archiving document management, and media management.

SEROLOGICAL CORP. (ex INTERGEN), Toronto, Ontario 2000-2004

Quality Control Analyst (part-time: Weekends, 2nd and 3rd shifts)

Conducted routine analysis of Bovine Serum Albumin (BSA) in alignment with established expectations, standards, and guidelines. Drove continuous improvement of all internal processes, standards, and procedures. Authored laboratory documentation for all projects, including lab record books, analytical data, project reports, forms, and memos.

Selected Achievements:

Ensured compliance with GLP, GMP, validation and regulatory guidelines for all analyses.

Authored SOP for determination of Alcohols by Gas Chromatography.

Performed Fatty Acid analyses by Gas chromatography.

Delivered an improved modified GC analysis of alcohol for in process and production.

Maintained a safe environment by monitoring and reporting any issues, including those with instruments

TECHNICAL SKILLS

Chemstation Empower Turboschrom EzChrom MassLynx LC-MS/MS

Microsoft Windows Mac OS UNIX ICONNMR, XWINNMR

Topspin Software, 1D & 2D Pulse Programs Perkin Elmer GC / Ion Trap Detectors

MicroMass Ultima LC-MS/MS with ESI&APCI for Isotopic Purity Determination Mass Hunt ICP-Mass Agilent

FT-IR & Raman Spectroscopy: Perkin Elmer & Nicolet

DSC, TGA, Elemental C, H, N, S Perkin Elmer Thermal Analysis GC Analysis HPLC Analysis DAD Fluorescence Electrochemical PAD Transdermal testing systems

ADDITIONAL ROLES:

Quality Compliance Laboratories, Markham, Ontario, 2015

Contract Supervisor, QC Laboratories.

Following monographs of USP, EP, JP, and BP for Wet Chemical Analysis.

Chemi Pharmaceutical Ltd., Mississauga, Ontario 2014

Short Term Contract: Determination of Hypophosphite Ca, Mg, Fe, Na by ICP-Mass, according to USP Guidelines.

Rose Scientific Ltd Sales and marketing manager: Liaised with clients to sell and implement laboratory Equipment, Conducted user training on equipment use and maintenance.

Unitech International Ltd.: Coordinated laboratory equipment sales as exclusive representative of Bruker and Perkin Elmer. Managed installation projects. Provided users with training and support.

FORMAL EDUCATION:

Master of Science in Analytical Chemistry

University of Birmingham – United Kingdom

Bachelor of Science in Chemistry

National (Melli) University

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