Cover Letter Manager
Resume:
Summary
Cover Letter
Current?Location US: Edison, NJ
Industry
Biotechnology / Pharmaceutical
Compensation
Current: about 110000
Desired: 950**-******
Willing?to?Relocate? Yes
Preferred?Locations,
Travel Availability
My?Perfect Job
Desired?Title
Cover Letter
Dear Recruiters or hiring Managers: I am currently seeking a pharmaceutical Analytical Principal Scientist or Manager positions, if you or hiring company has these opening positions. I believe my background and qualifications will be very well matched to your job?s requirements. Therefore, I submit my resume and cover letter to you or hiring managers for review and consideration. I have significant work experience in Pharmaceutical Analytical R&D department, and I have even more achievements in professionally implementing methods development, validation and impurity profile. Due to my familiarity of modern spectroscopy and organic chemistry, I have the ability to elucidate and identify drug and products\' unknown degradants\' chemical structures to fulfill FDA requirements. I also have the ability to write validation reports to support NDA and ANDA filings. I have cooperated with formulation research, by creating and developing new methods to help the formulation department to improve their in-process or final drug dosage forms through these dosages in the designed dissolution, stability, forced degradation and solvent extraction tests. In addition, I have more experience in troubleshooting with drug problems in its formulation, production, stability tests, analytical methodology and FDA deficiency letters in current and former working companies, these include writing technical reports, test methods, responding to FDA deficiency letters and supporting regulatory submission. As a group or project leader, I have the managerial and organizational experience to lead team members to outperform expectations on research projects. These include assigning group members daily work and scheduling workflow, checking notebooks, reviewing test data and Lab reports, analyzing chromatogram and data, approving test results and preparing technical reports, and providing final documents for regulatory submission. I have also performed technical training and SOP training in the department. I have knowledge of cGMP and GLP, and I am familiar with FDA/ICH guidelines, so I have reviewed and written some SOP or QAS documents for the Analytical R&D department. In this year, I have charged duties in reorganizing analytical R&D and setting up a new analytical Lab in the San Diego site for protecting ?lan\'s commercial products and supporting NDA/ANDA filings and regulatory submission.
I am a good team leader and player and a diligent person who enjoys working on difficult problems and solving them. I also have a strong sense of responsibility and the ability to work independently. Therefore, I am sure that my professional knowledge, skills in both analytical and organic chemistry fields and good personality will enable me to play a constructive role to your company. Having received intensive interdisciplinary training, I am confident that I have the ability and eagerness to overcome any new challenges. I sincerely hope that we will have the opportunity to further discuss the specifics of your requirements. Thank you for your time and thorough consideration. Sincerely yours, Applicant: Ben-Yi Ji
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Resume
Ben Yi Ji
Ph.D.
Home: 108 East Calvert Avenue, Edison, NJ 08820, Tel (H): current: 619-***-****; after 3/13/04,732-***-****; eFax: 646-***-****, Email: abo1ry@r.postjobfree.com
CAREER OBJECTIVE:
Principal Scientist, Group Leader, or Department Manager in Pharmaceutical Development, Quality & Analytical R&D; Pharmaceutical Process R&D; or drug chemistry research.
SUMMARY:
Management & technical experience in pharmaceutical R&D, drug chemistry research
? Management experience in Analytical R&D Lab, and instrument maintenance, successfully organizing and leading team members to outperform expectations on the R&D research projects.
? Demonstrated in-depth, wide analytical and organic chemistry knowledge & background, and modern instrumentation knowledge, skills & hands-on experience.
? Analytical R&D experience in methods development, validation, impurity profile & identification, and chromatographic data analysis & interpretation.
? Analytical method\'s technical transfer, technical protocol, validation report, or SOP document writing in compliance with ICH/FDA regulation and guidelines.
? Broad experience and knowledge in separation and purification by HPLC (analytical/preparative column), TLC, or Wet column Chromatography.
? Hands-on and knowledge in modern spectroscopic techniques such as FT-NMR (1H & 13C), FT-IR, UV/VIS, GC, GC-MS & LC-MS, and interpretation of these spectra.
? Troubleshooting ability in drug formulation, production, stability and dissolution study, analytical methodology and response to FDA deficiency letter.
? Synthetic organic/bio-organic experience, reaction pathway & mechanism study.
? Knowledge of cGMP/GLP & ICH/FDA regulation and guideline.
? Teaching experience in analytical/organic research, Lab technical & instrumentation skills.
COMPUTER Skills:
Familiarity with IBM PC-Microsoft: Excel, Word; WordPerfect; Millennium; Turbochrom; ChemDraw; MPG (Molecular Presentation Graphics) and data statistics.ACHIEVEMENTS:
In Nov. 2001, FDA gave my research and validation reports a praising evaluation, when they reviewed Mirtazapine ANDA filing that was submitted by IVAX. They said: \"This Mirtazapine validation report is a model filing and excellent job, it should be reviewed with the entire company; let everybody read and learn\". This project was completed independently, included all work from methods development to validation, and six different validation reports writing.
EXPERIENCE:
As a principal scientist or group/project leader, I organized & performed research activities to support NDA/ANDA filings, formulation research, to solve troubleshooting and to respond FDA deficiency letter, etc. at Elan, IVAX, Duramed & Penick Pharmaceuticals Inc. Made key contributions in drug evelopment or process in narcotics, anti-narcotics, amphotericin, nicotine, hormones & contraceptives, mertazapine, metformin, leflunomide, glimepiride, flavoxate and isoflavones, etc.
Methods development/validation for drug analysis and validation report writing
? Professional high quality in HPLC Methods Development for separation and quantitation of active ingredients and impurities/degradants for drug substance, dosage forms and drug products.
? Validation: specificity, precision, accuracy, LOD/LOQ, range & linearity, ruggedness & robustness.
? Carried out forced degradation, peak homogeneity, impurity/degradant elucidation & identification study.
? Solid dosage forms\' dissolution study, hardness, disintegration, homogeneity and uniformity test and drug substance\'s particle size, polymorphism and volatile organic residues study.
? Stability Study for drug substance and dosage forms.
? Review and write Technical Protocol, Validation Report and SOP/QAS documents.
2002-presentSenior Scientist (II), Elan Pharmaceutical Inc., Miramar site, FL & San Diego site, CA
Working in Quality & Analytical Development Department, taking Project Leader duties to support NDA filing, technical troubleshooting to protect ?lan\'s commercial products. Assumed R&D Head duties, to set-up Analytical Lab and reorganize Analytical R&D in San Diego site.
2000-2002
Senior Research Fellow, IVAX Pharmaceuticals, Inc., Northvale, NJ
Taking Project leader duties, working in Analytical Research Department
1999-2000Research Scientist (III) - Senior, Duramed Pharmaceuticals, Inc., Somerset, NJ
Taking Group/
Project Leader and Lab Manager duties, working in Analytical R&D Department1996-1999
Senior Chemist, Penick Corporation, Newark, New Jersey
Taking Project Leader duties, working in Research & Development Department
? HPLC methods Development & validation for bulk narcotics (control substance).
? Developed HPLC methods to monitor & quantitate anti-fungous Amphotericin-B in the entire process from fermentation (three steps: 250ml to 32000-gallons tank) to final release product, it prevented batches of qualified products from being
dumped per year (saved $0.5 million per year).
? Troubleshooting: controlled impurity accumulation in Amphotericin-B Production process (saved $1 million per year).
? 7 Patents issuing for developing new approaches to synthesize narcotics, (These patents are worth $5 million).
1994-1996
Senior Research Fellow, American Health Foundation, Valhalla, New York
Working in Division of Cancer Etiology & Prevention
Study of chemical carcinogenesis & cancer chemoprevention
? Developed HPLC methods in vivo study of potential human endogenous carcinogens-estrogen and cholesterol-5a, 6a-epoxide & -5?, 6?-epoxide and environmental carcinogens, 4-nitropyrene, 4-nitropyrene-9, 10-epoxide, etc.
? Carried out in vitro metabolism of 4-nitropyrene and 4-nitropyrene-9, 10-epoxide with DNA, developed HPLC method to isolate DNA-adduct, metabolites,
and identified their structures.
? Synthesized cancer chemopreventive agents: organoselenium-glutathione conjugates.
1985-1993Working and studying at New York University, New York City
(
1992-1993)
Research Assoc. Scientist, working in Chemistry Department
? In the cancer chemoprevention study, searched for potential anti-turmeric reagents to compete with carcinogenic polycyclic aromatic amines, preventing carcinogen-dG adduct formation.
(
1988-1992)
Research Assistant, working in Chemistry Department
? Systematic in vitro study of mono-aromatic amine carcinogenesis. It was found
that the key intermediates - nitrenium ions formation will cause or form chemical carcinogenic pathway.
(
1985-1987)
Teaching Assistant, working in Chemistry Department
? Instructed undergraduate course: \"Modern Experimental Organic Chemistry\"
1982-1984WHO Collaborating Center for Research in Human Reproduction, Shanghai, China
Assistant Scientist & Supervisor, working in Division of Medicinal Synthesis
? Developed asymmetrical synthetic approaches for synthesis of Sulprostone - Prostaglandin E2 analog. This synthesis involves 27 synthetic steps.
1981-1982Shanghai Institute of Materia Medica, Academia Sinica, Shanghai, China
Senior Undergraduate Student, as researcher working in Division of Medicinal Synthesis
? Designed and synthesized Chemopreventive berberine analogs with betaine structure. These structures corresponded to the \"N-O-O Triangle Theory\" for
design of anti-cancer drugs proposed by C. C. Cheng. This project was for my
B.Sc. (Eng.) degree thesis.
EDUCATION:
1992-1993
Post-Doctorate, in Physical Organic Chemistry, New York University, NYC
1/1992
Ph.D. in Physical Organic Chemistry, New York University, NYC.
Dissertation: \"Study of Possible Hydroxamic Acid Precursors to Aryl Nitrenium
Ions\". This dissertation was given a higher evaluation with a grade of \"A\" by NYU chemistry department, Professor Committee and it was published in 1992.
1/1988M.Sc., in Organic Chemistry, New York University, New York City
.
1/1982B.Sc.(Eng.), in Chemical Pharmaceutics & Chemical Engineering,
East China Univ. of Science & Technology (ECUST), Shanghai, China.
B.S. Thesis is \"Synthesis of Berberine Analogs for Chemotherapy to Tumor\". It was given a high grade of A, and collected to the published book \" Outstanding Undergraduate Theses and Designs at ECUST\" in Sept. 1982.
PUBLICATIONS:
1. Seven patents generally entitled \"Preparation of 14-Hydroxynormorphinones,
Oxycodone, Noroxymorphone, Oxymorphone and Naltrexone from Normorphinones\" were filed to U.S. Patent and Trademark Office in July 1997.
Each patent was issued, and their titles are \"Preparation of 14-HydroxyNormor-phinones from Normorphinone Dienol Acylates\"(issued Feb.9, 1999), \"Preparation of oxymorphone from morphine\"(issued, July 13, 1999), \"Normorphine and Normorphinone Derivatives\" (issued, Sept. 7, 1999), \"Preparation of 14-Hydroxy-normorphinones from Normorphinones\" (issued, Sept. 14, 1999), \"Preparation of noroxymorphone from morphone\" and \"Preparation of oxycodone from codeine\" (both issued, Dec. 28, 1999) and \"Preparation of Naltrexone from Codeine and 3-Benzyl-morphine\" (issued, Jan. 11, 2000).
2. \"Evaluation of the turmerigenicity of cholesterol epoxides and estrone-3, 4-
quinone in the rat mammary gland\", Cancer Research, 56, 1970-1973, 1996.
3. \"Comparative Metabolism and DNA Binding of 1-, 2- and 4-Nitropyrene in Rats\"
was submitted to Mutation Research, in Press, 1996.
4. \"On the identification of DNA adducts derived from the environmental mammary
carcinogen 4-nitropyrene in rats\" was submitted to Cancer Research, 1995.
REFERENCES:
Dr. Jim Huang Phone: 954-***-**** (W)
Former Associate Director, Quality and Analytical Development Dept., Elan
Pharmaceutical, Inc. (Florida site), FL. He currently works in Abrika
Pharmaceuticals, Inc., FL
Serge Gaspard Phone: 201-***-**** x 234 (W)
Director of Analytical Research Dept., IVAX Pharmaceuticals, Inc., NJ
Dr. Shangzheng Lu Phone: 973-***-**** (W)
Former Director of Analytical R&D Dept., Duramed Pharmaceuticals, Inc., NJ. But Duramed AR&D Dept. has been moved to Cincinnati (Ohio) - Duramed headquarter since 2000. Dr. Lu currently works in NJ other Pharmaceutical company.
Dr. Bao-Shan Huang Phone: 973-***-**** (W)
Director of Quality andR&D Department, Penick Corporation, NJ
Dr. Graham R. Underwood Phone: 212-***-**** (W)
Research Advisor for my Ph.D. dissertation, Assistant Dean of Graduate School
of Arts and Science, New York University, NYC.
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Contact Information
Ben-Yi Ji
108 East Calvert Avenue
Edison, NJ 08820
US
email abo1ry@r.postjobfree.com
Phone: 732-***-****
Phone: 619-***-****
Industry: Biotechnology / Pharmaceutical
City: Edison
State: NJ
Zip: 08820
Country: US
Date: 00000000
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