FARAH DEAN Home: 609-***-****

**** ******** *** ****: 310-***-****

Plainfield, IN 46168 adzzcx@r.postjobfree.com

Page 1 of 4

PROFESSIONAL SUMMARY

Experienced Global Pharmaceutical Scientist offering physical characterization of Solid dosage forms; tablets, Softgels, Drug substances, and excipients. Total 15+ experience with Pharmaceutical Industry for method development, validation, technical operations, pre- formulation and tech transfers.

EXPERIENCE:

Catalent Pharma Solution. develops, manufactures, markets, and distributes brand pharmaceutical products. 2022 – Present. Position: Pre-formulation Scientist.

• Responsibilities/Achievements are:

• Primary responsibilities in formulation prototype development include: o Conducted Excipient Computability study using XRPD method o Write protocols, development summary reports, EC reports, tech transfer reports o Conduct cGMP Stability Study by XRPD method

o Perform API evaluation using physical characterization techniques (XRPD, PSD, Microscopy, SEM and Thermal analysis)

o Completed Laboratory notebooks and batch records in compliance with cGMP and SOP requirement

o Conducted safety inspection of all Pre-formulation labs o Conducted Particle Size Method Transfer activities from Laser Diffraction Particle Size Analyzer (Mastersizer 2000) to another Diffractometer (Mastersizer 3000)

o Give Scientific Presentations and drafted SOPs and reports o Perform Particle Size and XRPD Method Validation Studies o Perform 5s activities in Lab every week

o Participate in 311 safety concern activities

o Completed all trackwise training timely manner

o Conduct equipment qualifications, calibrations, troubleshooting, and maintenance o Participates other Catalent sites groups, and scientific discussions to develop external network

o Handle Controlled Substance drug substance and conduct analytical testing Watson/ Actavis / Allergan / AbbVie, Inc. develops, manufactures, markets, and distributes brand pharmaceutical products. 2006 – OCT-2021. Position: Science and Technology Global Pharmaceutical Scientist.

• Responsibilities/Achievements are:

• Follow-up literature (scientific and patent) to create new development opportunities for pharmaceutical development

• Drives quality risk assessments as well as effectiveness checks as a part of change control and CAPA

• Training experience in Trackwise, Coral and one volt FARAH DEAN Home: 609-***-****

6881 WoodWard Way Cell: 310-***-****

Plainfield, IN 46168 adzzcx@r.postjobfree.com

Page 2 of 4

• Experience in investigation of out of specification of PPQ and pilot batches of ophthalmic and SkinMedica products

• Investigate, create, and develop new methods and technologies to improve the effectiveness of development workflows

• Troubleshoot and improve existing processes, tools, and chemistries to create robust products and improve process performance

• HPLC, UV-VIS, FTIR, PSD, XRPD, DSC, TGA, SEM, Zetasizer, Morphology G3, adsorption/desorption, Optical microscopy, Zoom microcopy, Surface area, True density, and Technical transfer / Commercialization.

• Method Development, Validation and Transfers.

• Performed method development, validation, and method transfer of PSD (Particle Size Distribution by laser diffraction, Sieving and Microscopy techniques), XRPD (X-ray powdered diffractions), DSC (Differential Scanning Calorimetry), and TGA

(Thermogravimetric Analysis).

• Quality, cGMP, SOP, FDA, Regional / Global GRA regulations.

• Alternate Drug Substance Evaluation.

• Written and Verbal Communication.

• Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics.

• Assist management in establishing new processes or methodologies to improve operational efficiencies

• Work on the development of new technologies or improvement of already established ones in investigations.

• Establish a close collaboration with Process Development and Analytical Development teams.

• Provide instruction on training program/purpose, the principle of the subject, SOPs, performing analyses, safety & proper handling/disposal, instrumentation/equipment/software, calculations, and GDP.

• Audits (safety, FDA, internal QA): Consulted and provided requested information.

• Develop/improve documentation.

o Create and revise procedures/policies. Facilitate and participate (varying roles: author, reviewer, approver) in the preparation of controlled documents or biennial review (e.g., GSOPs, CSOPs, CFORs, CQPs, TM, COAs). Phenomenex, Inc., a chromatographic column manufacturing company. 2001 – 2006. Starting position: Laboratory Technician in Production Dept. Last position: Quality Control Analyst in R&D Dept. Responsibilities/Achievements included:

• Techniques/Instruments:

o Physical characterization including Particle Sizing (Malvern Mastersizer), Elemental analysis (flash combustion/GC), pore volume/surface area analyses, Flow tests to check packing quality of tubes, Dye tests to determine how well the product absorbs a specific compound, and Gravimetric analyses to assess if production machine is packing correctly.

FARAH DEAN Home: 609-***-****

6881 WoodWard Way Cell: 310-***-****

Plainfield, IN 46168 adzzcx@r.postjobfree.com

Page 3 of 4

o HPLC for batch testing, i.e., to check metal content, silanol activity, and hydrophobic interactions (detectors: UV, Fluorescent).

o GC for batch testing, i.e., checking the purity of solvents (detectors: FID, MS).

• Quality Control/Assurance:

o Tested and performed stability analyses for 95 established products and experimental products.

o Maintained the lab (supplies), instruments (troubleshooting), and column/sample archives.

• Documentation/Training:

o Created/prepared all Certificates of Analyses for HPLC stationary phases. o Record keeping of batch records and authorization to release new batches to shipping. o Presentation to Sales regarding ion exchange (SAX/SCX) products. o Some application developments for marketing purposes. Brochures are available upon request.

• Method Development:

o Conducted evaluations on new/experimental products and performed competitor comparisons.

Professional Training:

• Numerous seminars/webcasts/courses/etc. including: o Fundamentals of HPLC and GC, Advanza Institute, Torrance, CA o XRD Application Training, Bruker AXC Inc, Madison, WI o XRD DIFFRAC.TOPAS Software, Watson Pharmaceuticals, Corona, CA o XRD D8 Discover with Hi-Star, LynxEye and Scintillation Detectors and Measurement, Pilot and Eva / Search software, Watson Pharmaceuticals, Corona, CA o HPLC Method Development Practices by Waters Educational Services, Anaheim, CA o Basic Microscope Use and Sample Preparation Techniques, Hooke College, Westmont, IL

o Inhaler Testing Equipment to methods described in USP section <601>, Watson Laboratories, Corona, CA

o Inhalers, Mighty Runt, MDI FD-10, NSP VA, Morristown, NJ o ACI installation and Operational Qualification by MSP Corporation, Shoreview, MN o NGI Installation and Operational Qualification by MSP Corporation, Shoreview, MN o Transitioning from Empower to Empower 3

o Particle Size Analyzer, Hosokawa Micron Powder System, Summit, NJ o Certificate of Completion of Hazardous Waste, Compressed Gas Cylinders, Resource Conservation Recovery Act, Corona, CA

o IXRF EDS, Operator’s Training, Watson Pharmaceuticals, Corona, CA o Certificate of Completion of Calibration, Method Development, Operation and Data Analysis of Hyper DSC (8500) and Pyris 1 TGA

o Certificate of Training on S-3400 N Variable Pressure Scanning Electron Microscope

(SEM), Hitachi High Technologies America, Inc, Watson Pharmaceuticals, Corona, CA o Setaram C80 Calorimeter Training by Setaram, Inc, Corona, CA o Fundamentals of Raman Spectroscopy Training, Perkin Elmer, Corona, CA FARAH DEAN Home: 609-***-****

6881 WoodWard Way Cell: 310-***-****

Plainfield, IN 46168 adzzcx@r.postjobfree.com

Page 4 of 4

o Certificate of Achievement of Zetasizer Software and PCS Theory, Watson Pharmaceuticals, Corona, CA

o Certificate of Completion of TA instruments DSC & TGA Theory & Applications Training Courses, TA instruments, North Brunswick, NJ o Certificate of Achievement of Malvern Mastersizer Particle Size Analyzers, Malvern, North Brunswick, NJ

o Certificate of Achievement for Texture Expert Exceed and Exponent Software, Watson Pharmaceuticals, Corona, CA

o Quality Assurance Training for Qualified Trainer, Watson Laboratories, Corona, CA o Refresher in Organic Chemistry, Avanza Institute, Torrance, CA Education:

• Master of Science Degree in Chemistry, University of Karachi, Pakistan 1989-1990.

• Bachelor of Science Degree in Chemistry (minors in Biochemistry & Microbiology), University of Karachi, Pakistan 1989.

REFERENCES:

* Excellent personal and professional references available upon request. *

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