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Process Chemistry, CMC, Project Management, Analytical Chemistry

Location:
Irvine, CA
Posted:
March 31, 2017

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Resume:

NAMIN KANG, Ph.D.

*** ****** ******, **. ***** Cell) 949-***-**** aczlbi@r.postjobfree.com

OBJECTIVE

A Ph.D. level position in research and development at a pharmaceutical or biotech company that specializes in process chemistry and CMC for drug substance

QUALIFICATIONS

Manage in a pharmaceutical setting including GMP process chemistry, project management, supervision and mentorship, proposal writing and review, cost estimation, and out-sourcing

Design and synthesis of complex organic molecules coupled with a solid knowledge of modern separation methodologies and spectroscopic identification techniques

Manage outsourced API and drug products development at CRO/CMO, responsible for all activities to ensure the requirement of API quality, on timeline delivery, and maintains operational methods and procedures

Lead and manage new develop and implement of high quality active pharmaceutical ingredients, synthetic route/cost effective process optimization, GMP process, and scale up

Collaborates with internal cross-functional teams and CRO/CMOs to determine manufacturing requirements, identify and mitigate key risks, and ensure that plans are executed as intended.

Revises and develop documents and reports related to CMC activities in support of filing sections of IND as a subject matter expert, and provides technical training and troubleshooting to staffs WORK EXPERIENCE

R&D Manager at Aspiras Scientific in Milpitas, CA. (May 2015 – Oct. 2016)

-Manage outsourced materials, and responsible for interactions for smooth API manufacturing process and tech transfer

-Manage all aspects of a project, execution of process, managing the budget, and communicating all client driven decisions

-Act as a designated project study director, whose main responsibility is to interface with clients to understand project in totality and direct the work ongoing to completion

-Design and optimizes the multi-step synthesis of variety of potential drugs for SAR (structure activity relationship) study and drug development

Sr. Chemist at Edwards Lifesciences in Irvine, CA. (Jun. 2013 – Jan. 2015)

-Manage CMO for outsourced materials and monitors and maintains a document on the assigned projects

-Major contributor in development of new chemistry, testing and evaluation of process chemistry

-Develops and reviews technically sound test plans, protocols and reports, and develops team members on new/ improved methods

Scientist at Ricerca Biosciences in Concord, OH. (Jun. 2011 – Apr. 2013)

-Optimize and propose synthetic routes to produce small molecule drug substances, the development and execution of chemical processes for molecules that the support GMP process chemistry, CMC, and tech transfer

-Design and synthesis of small drug molecules based on multi-dimensional analysis including SAR, safety, and/or pharmacology data aligned to project goal

-Review, write and support proposal activities that lead to new projects

Synthetic Organic Chemist at Tjaden Biosciences in Burlington, IA (Jan. 2008 – Jun. 2011)

-Synthesis of small drug molecules, process development, scale-up and optimization from laboratory scale to pilot scale

-Comprehensive research and experimentation with stable label and radioisotopes in the synthesis of biologically active compounds towards the manufacture of API

-Maintain schedule and productivity of the labs, reviews incoming chemistry

Research Scientist at Regional Research Center (RRC) sponsored by Korea Science and Engineering Foundation (KOSEF) in Pusan, South Korea (Mar. 2000 – May 2002)

-Discovers and develops new synthetic and analytical routes and methods for the preparation, purification, and characterization of new and novel organic and bio-organic compounds EDUCATION

Ph.D., Chemistry, 2007

Florida Institute of Technology, Melbourne, FL

M.S., Polymer Science and Engineering, 2000

Pusan National University, Pusan, South Korea

B.S., Chemistry, 1998

Kosin University, Pusan, South Korea

PUBLICATIONS

"5-Oxo-ETE Receptor Antagonists",

J. Med. Chem. 2013, 56, 3725.

"Eicosapentaenoic-acid-derived isoprostanes: Synthesis and discovery of two major isoprostanes", Bioorg. Med. Chem. Lett. 2008, 18, 5523.

"Reductive Deprotection of Silyl group with Wilkinson’s Catalyst/Catechol Borane", Tetrahedron Letters, 2007, 48, 5289.

"An Efficient Preparation of Stereospecific ß-hydroxy nitriles", Tetraheron Letters, 2005, 46, 161.

"Syntheses, Anti-tumor and DNA Replication Activities of Polymers Containing Vinyl-(5-fluorouracil)-ethanoate", Polymer International, 2002, 51, 443.

"Effect of Molecular Weight of Poly(exo-3,6-epoxy-1,2,3,6-tetrahydrophthalic anhydride) on Anti-tumor Activities and Release Rate of Its 5-Fluorouracil Derivative", Korea Polymer Journal, 2001, 9, 5, 277.

"Synthesis and Biological Activity of Medium Range Molecular Weight Polymers Containing Exo-3,6-epoxy- 1,2,3,6-tetrahydrophthalimidocaproic acid",

Polymer International, 2001, 50, 1010.



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