Description
Principal or Sr. Scientist in Pharmaceutical Analytical R&D, or drug development
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| (Confidential) | Sr. Scientist in Mehtod Development | 7/2009 - Present |
| Hovione LLC | Principal Analytical Scientist | 10/2007 - 8/2008 |
Accomplishments
Highlights:
14-year pharmaceutical industrial working experience, made key contributions in methods development/validation to analyze assay & impurities of drug products or API; write analytical validation protocol/report, or solved big problems in trubleshooting to support drug development, NDA/ANDA filings & API synthesis. Through to my individual or team work, at least 12 drug filings received FDA approval. These are several narcotic /anti-narcotic bulk API or drug products (morphine, oxycodone, hydrocodone & naloxone), amphotericin-B (fermentative bulk API), nicotine (transdermal dosage), several hormones & contraceptives products (tablets, ER), mertazapine (tablets, XR), metformin (XR & ER, tablets), leflunomide (tablets, XR), glimepiride (tablets, XR), flavoxate (tablets, XR), isradipine (capsules, XR & tablets, ER), olanzapine (capsules, XR), alandronate sodium (tablets, XR), benzonatate (soft gel), chiral drug of L-hyoscyamine (tablet, IR), tramadol (injection solution) and combination of chlordiazepoxide hydrochloride/clidinium bromide (CDP/CB) (capsule, IR) & valsartan/HCTZ (Hydrochlorothiazide), (tablets, XR).Companies I like:
Pharmaceutical Company or Drug development and research
Responsibilities
Management experience in Analytical R&D, instrument maintenance, project progress; and working schedule to meet project goal and timeline; manage team or individual work to perform methods development, validation, method transfer, troubleshooting and stability test, summarize drug analytical data and write validation protocol and report, or technical report to support formulation research, drug development, NDA/ANDA filings and Regulatory submission.
