Engineer Ii Process Development
Resume:
Ming Der Yu, BS, MS, Ph.D.
*********@*****.*** 248-***-****
PROFESSIONAL EXPERIENCE
Lead Radiochemist (R & D Scientist Engineer II), November 2023 to present. Stanford University School of Medicine, Stanford, California
• Liquid target F-18, C-11, N-13 radiopharmaceuticals
• Solid target (radiometals): Ga-68, Cu-64, and Zr-89 radiopharmaceuticals
• Alpha and beta Ac-225 and Lu-177 radiopharmaceuticals Senior Process Chemist, October 2021 to October 2023 AtomVie Global Radiopharm Inc (Spin-off of CPDC), Hamilton, Ontario
• Under cGMP, manufacturing radiopharmaceuticals for diagnostic and therapeutic
(CDMO and CMO): Lu-177, I-131, Ac-225, F-18 Radiopharmaceuticals
• Writing development reports, MBR (master batch records), Engineering run protocol and process validation protocols and reports, analytic protocols and report
• Assist in NC (Non-compliance), Investigation OOS, CAPA, PC (product complaints), CC (change control), risk assessment.
• Internal meetings (collect meeting materials with customer) and external meetings with customers (process development and validation, analytical overview (chemistry, QC and microbiology), document list (QA-SPEC, materials inventory, MBRs, validation protocols and reports), and action Items Senior Radiochemist, December 2019 to June 2020
NCM-USA Bronx, NY
• Under cGMP, manufacturing Radiopharmaceuticals for Theranostic (contract manufacturing organization): I-131 Iomab, Lu-177 PSMA-617, Ac-225 Lintuzumab, Ga-68 PSMA-11
• Manufacturing of IND Radiopharmaceuticals: F-18 tau imaging agents, F-18 rhPSMA
• Manufacturing of PET Radiopharmaceuticals: F-18 FDG, N-13 ammonia Radiochemist, February 2019 to November 2019
CTRIC Cyclotron and Radiochemistry, University of Colorado, Aurora, Colorado
• Operate automated radiochemistry synthesis equipment (GE tracerlab CPro and FXFN) for production of PET radiotracers (C-11: PiB, Acetate, Flumaenil, Choline, April 2024 Page 2
Methionine, and F-18: FLT, MISO, FTHA, FES) in compliance with protocols and regulations (FDA RDRC, USP823) for human and animal use.
• Perform routine analysis using Quality Control procedures in compliance with protocols and regulations.
• Setup, run and maintain automated synthesis modules, analytic instrumentation
(HPLC, GC, PTS, MultiChannel Analuzer) and other laboratory equipment
• Assist in the development and conduct process validations and stability procedures for PET radiotracers.
• Calibration and qualification (IQ/OQ/PQ) of equipment in compliance with regulations
• Participate in the resolution and investigations associated with Non-Conformance Processes (OOS, CAPA, and deviations)
• Create, review and revise technical documents including Standard Operating Procedures (SOPs), Master Batch Records (MBRs) and Specifications PET Drugs Operations Manager, June 2017 to December 2018 Ionetix Corporation, Sarasota Florida
• Assist designing a PET drugs production new facility meeting 21CFR212.
• Under c GMP, manage production of PET radiopharmaceutical products at the facility; ensure sufficient doses are produced on schedule to meet daily orders.
• Liaise with quality assurance to roll-out and sustain novel radiopharmaceutical production for IND and aNDA application.
• Manage multi-disciplinary teams (production, QA/QC, etc.)
• Implement and maintain processes (SOP, validation, microbiology program)
• Facility RSO and implement and maintain proper radiation safety.
• Manage and lead non-conformance related investigations; manage corrective and preventive actions (CAPA)
Senior PET Radiochemist, July 2011 to May 2017 Beaumont Health, Royal Oak Michigan
• To complement the Molecular Imaging, a Research Radiochemistry facility was developed. The radiochemistry facility consists of a preparation area, quality control area, clean room and delivery area. Two mini hot cells that housed in radiochemistry sets to produce F-18 and C-11 radiolabeled probes are also installed and in use.
• PET tracers production, quality control and quality assurance meeting USP 823: F-18 FLT, F-18 FMISO, F-18 FET, F-18 FAZA, F-18 ethylcholine, C-11 Choline, C-11 methionine by GE Tracerlab FX-N and FX-CPro, respectively.
• Using quality control equipment including Agilent HPLC with Lablogic Ram and IC detector, Agilent GC, Eckert & Ziegler RadioTLC, Canberra Multi-Channel Analyzer April 2024 Page 3
(MCA). Also, I have the experience in sterility test (endotoxin testing), medium fill stimulation test, growth promotion test, and aseptic technique.
• Member of RDRC committee
Radiopharmacy Coordinator March 2007 to June 2011 University Health Network-Toronto General Hospital, Toronto Canada
• Radiopharmaceutical production: Tc-99m Sodium pertechnetate, Tc-99m MDP, Tc-99m DTPA, Tc-99m Sulphur Colloid, Tc-99m MAA, Tc-99m MIBI, Tc-99m Myoview, Tc- 99m ECD, Tc99m Ceretec, Tc-99m Ceretec WBC, Tc-99m DMSA, Tc-99m Mebrofenin (CHOLETEC), Tc99m Gluceptate, Tc-99m Mertiatide (MAG3), In-111 Oxine WBC, In-111 Octreotide, and I-123 MIBG
• Supervise daily manufacture, QC testing, dispensing, and packaging of radiopharmaceuticals
• Oversee sterility assurance of final products, including environmental monitoring, aseptic processing, and media fill simulations.
• Manage the Quality Assurance Program of the production facility. Radiopharmacy Manager, March 2004 to February 2007 GE Healthcare, Toronto Canada
• Assist designing a SPECT radiopharmaceutical production new facility meeting 21CFR210. Managed the operations of a radiopharmacy and ensured products were dispensed in a timely and accurate fashion. Maintained consistent records of meeting all regulatory standards with Health Canada, CNSC, Transport Canada, WSIB, and Waste Management.
• Supervised radiopharmacist, nuclear medicine technologist, and pharmacy technician, including hiring, training, and performance review.
• Ordered, received, compounded, and dispensed radiopharmaceuticals daily.
• Labelled white blood cells for abscess detection daily.
• Quality control division and completed records of master production, calibration, and quality control for GMP and CNSC audit.
EDUCATION:
Doctor of Philosophy, Purdue University
Department of Medicinal Chemistry and Molecular Pharmacology, Purdue University West Lafayette, Indiana, U.S.A.
Major Professor: Stanley M. Shaw, Ph.D.
Ph.D. Thesis: Pharmaceutical Factors That May Affect Diagnostic and Therapeutic Outcomes of Thyroid Disorders
Master of Science, Purdue University
Department of Medicinal Chemistry, Purdue University West Lafayette, Indiana, U.S.A.
Major Professor: Stanley M. Shaw, Ph.D.
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M. S. Thesis: Pyruvaldehyde Bis(N4-methythiosemicarbazone), A Potential Agent for Labeling Leukocytes with Positron-Emitting Copper
Bachelor of Science in Pharmacy
School of Pharmacy, National Defense Medical College, Taipei, Taiwan ARTICLE IN REFERRED JOURNALS:
Full Papers
1. Yu MD, Shaw SM. Potential interference of agents on radioiodide thyroid uptake in the euthyroid rat. J Nucl Med 2003; 44:832-838
2. Yu MD, Huang WS, Cherng CC, Shaw SM. The effect of formulation on reduced radioiodide thyroid uptake. J Nucl Med 2002; 43:56-60
3. Cherng, CC, Yang SP, Yu MD, Chen CH, Fan YM, Yang GT. A survey of the knowledge and attitude on pulmonary embolism detection with lung scanning among clinical physicians in a teaching hospital. Ann Nucl Med Sci 2002; 15:119-127
4. Yu MD, Den-San Hsieh, Liou WL, Perng JC, Cherng CC, Huang WS. A study of early radioiodide thyroid uptake. Ann Nucl Med Sci 2001; 14:155-160
5. Yu MD, Liou WL, Perng JC, Cherng CC, Huang WS. A comparison of dissolution profiles for domestically available radioiodide capsules. Ann Nucl Med Sci 2001; 14:27-32 6. Yu MD and Huang WS. The proposal for good nuclear pharmacy regulation. Ann Nucl Med Sci 2000;13:233-8
7. Yu MD, Peck GE, Scott-Moncrieff JC, Blevins WE, Shaw SM. The effect of formulation on radioiodide thyroid uptake in the hyperthyroid cat. Drug Dev Ind Pharm 1999;25:565-70 8. Yu MD, Quinton T, Shaw SM. Influence of iodide-131 solution volume and storage time on in vitro dissolution. J Nucl Med Technol 1998; 26:27-277
9. Yu MD, Huang WS, and Shaw SM. Pharmaceutical factors that may affect diagnostic and therapeutic outcomes of thyroid disorders. Ann Nucl Med Sci 1998; 11:41-55 10. Chen WL, Perng MY, Hwei DZ, Yu MD. Therapeutic drug monitoring can avoid iatrogenic alterations caused by Tc-99m methylene diphosphate-gentamicin interaction. J Nucl Biol Med 1994; 38(Supple. 1 to 4): 132-4
Abstracts
1. Yu MD, Shaw SM. Interference of Agents on I-131 Uptake. J European Nucl Med Annual Congress of the European Association of Nuclear Medicine August 23 - 27, 2003, Amsterdam, The Netherlands 2. Yu MD, Hsieh DS, and Huang WS. The preparation of Tc-99m labeled liposomes by a cationic SP/DOPE formulation for tumor imaging. 2002 8th congress of the world federation of nuclear medicine and biology, Santiago, Chile, 2002
3. Yu MD, Cherng SC, and Huang WS. The effect of formulation on radioiodide thyroid uptake JAPhA 2001; 41:305
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4. Yu MD, Cherng SC, and Huang WS. Therapeutical outcomes after radioiodine treatment by two different gland-weight estimations in hyperthyroid patients: survival analysis. JAPhA 2000; 40:292 5. Yu MD and Huang WS. Separate and additive effects of substance that decrease thyroid radioactive iodine uptake. 72nd annual meeting of the American Thyroid Association 1999
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