YUN WU

Malvern, PA *****

C 845-***-****

ad34oi@r.postjobfree.com

SUMMARY

Experienced and Motivated Analytical chemist with over 20 years R&D experience in the pharmaceutical industry: Developed, validated, executed, and transferred HPLC and UPLC methods for active pharmaceutical ingredients, provided analytical support in a quick and flexible manner to meet demanding timelines on projects from early development through registration to marketed products. Prepared, reviewed and audited data/reports for IND, NDA and ANDA submissions. Excellent knowledge of cGMP, GLP, ICH regulations, DEA compliance and USP monographs, strong communication and team building skills. TECHNICAL SKILLS / EXPERIENCE

• Analytical technology: Extensive experience with HPLC, UPLC, GC, UV Spectrophotometer, fluorescence, CAD and RI detector, GPC, SFC, TLC, IC and Wet Chemistry. Technical expertise in providing HPLC and UPLC support for method development and validation of small molecule, peptides, and proteins formulation at various stages of development for qualitative and quantitative analyses.

• Biotechnology: ELISA, SEC, HPLC/UPLC, CE, icIEF for biopharmaceutical products, protein isolation and purification, DNA isolation, bioassay.

• Computer Skills: ELN (vision publisher), Empower 3/Millennium, TotalChrom, ChemStation, LIMS, ChemDraw, Drylab(2D and 3D), JMP, Word, Excel, and PowerPoint PROFESSIONAL EXPERIENCE

Associate Scientist 01/2017-present

Teva, West Chester, PA

• Perform method validation, batch release, stability and BMF testing for raw material, drug substances, in-process drug products and final drug products, support lab investigations and method troubleshooting, write/revise SOP

Lead Researcher 05/2013-01/2017

Teva, Pomona, NY

• Perform method development and method validation for highly unstable parenteral finished products containing peptides/small molecules (e.g. assay and impurities methods for parenteral solutions, lyophilized powders, and modified release products). Provide analytical support for formulation development including assay, impurity, dissolution, and polymer molecular weight determinations. Support multiple complex stability studies based on Design of Experiments to maximize stability of drug product. Perform autoinjector device and Pre filled syringe testing such as delivery volume and stopper height measurements respectively. Responsible for review of in- house analytical data as well as analytical data generated by CMO.

• Provide solutions to challenging analytical methods using in-silico method optimization software such as Drylab, literature searches, and statistical software JMP.

• Empower and electronic notebook SME (subject matter expert). Provide technical training and guidance to new and junior employees.

• Efficiently review/audit data and reports to ensure compliance and quality for ANDA, 505b2 submissions and Phase 1 clinical studies.

Scientist II 11/2010-02/2013

Sandoz (a Novartis Company), East Hanover, NJ

• Audited analytical data, validation and stability reports in AR&D department ensuring that all of the raw data met quality standards for timely ANDA filings. Significant auditing experience. Senior Research Scientist II 02/1995-07/2010

Pfizer (Legacy Wyeth Research), Pearl River, NY

• Supported solid dose formulation development and global stability studies for IND and NDA submissions in a cGMP environment by testing a variety of dosage forms (e.g. tablets, capsules, tablets in capsule and sugar-coated tablets) for development and registration batches including assay, identity, impurity/degradation, content uniformity and chiral compounds determinations by HPLC and UPLC.

• Performed HPLC and UPLC method development and validation on early development through registration batches to marketed products.

• Performed technology transfer of analytical methods to multiple global sites.

• Authored analytical methods and validation reports, contributed to the creation of reports for regulatory submissions.

• Implemented and trained Scientists on departmental SOPs, methods, software & techniques.

• Conducted lab investigations for out-of-specification (OOS) results and identified root causes.

• Participated in preparation for yearly cGMP compliance audits; no audit issues uncovered.

• Reviewed lab personnel notebooks for compliance with FDA regulations and internal SOPs.

• Recipient of an Above & Beyond Award.

EDUCATION

MS, Biochemistry, East China University of Science and Technology, Shanghai, China Thesis: Chemical modification of superoxide dismutase using dextran, its property, bioactivity and metabolism in mice.

BS, Biochemistry, East China University of Science and Technology, Shanghai, China

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