Bum Kim is seeking a career in regulatory affairs in the pharmaceutical/biotech industry. He has a M.S. in Regulatory Affairs and extensive experience in various regulatory roles, including technical writing, auditing, clinical research monitoring and compliance. His background includes research experience in drug discovery and development. He is proficient in FDA and international regulations regarding drugs, biologics and medical devices.

1. Bum Kim, M.S.
Suwanee, GA 30024 (510) 709 - 7441
www.linkedin.com/in/bumkim bryantbumkim@yahoo.com
OBJECTIVE
To pursue a challenging career in Drug, Biologics, and Medical Device Regulatory Affairs and become a part of an
esteemed organization where I can use my skills, knowledge and experience to contribute in DMRs,Technical files,
Design Dossiers, IND application/EUA documents, CAPA, CMC compilation, QSR’s, ISO, CRFs, Clinical Study
Monitoring, ICH/GCP guidelines and Project Planning to the growth of the organization.
SUMMARY
 Accustomed to working with project teams and providing research and advice on compliance with federallaws
and FDA/USDA regulatory agency guidelines, SOP preparation, updated good laboratory practices.
 Strong knowledge of Medical Device Reporting (MDRs), Medical Vigilance Reporting (MDVs), risk
management, validations, design controls, process development, monitoring, statistical controls and root cause
analysis.
 Participated in audits performed by internal and external representatives for ISO and FDA compliance.
 Familiarity with the drug and medical device development process – cGMP (DMF), GLP, GCP, QSR, IND,
NDA, BLA, 510K, PMA, Informed Consent, IRB review, and ethical principles (Belmont Report) in clinical
research.
 Solid working experience in the pharmaceutical industry – New Drug Discovery Research.
 Familiarity with standard concepts, practices, and procedures within a biotech/life sciences field.
 Methodical, quick-learner and highly independent team player, problem solver and can troubleshoot any
scientific issues.
 Ability to multi-task and to establish and maintain good working relationships at all levels.
 Strategic thinker with strong attention to detail and with excellent communication skills.
EDUCATION
Northeastern University Boston, MA
Master of Science in Regulatory Affairs September 2015
Concentration in Drugs, Biologics and Medical Devices,GPA: 3.6 (4.0)
Relevant Courses: Drug and Medical Device Regulation, Human Experimentation, New Drug Development:
Regulatory Overview, Medical Device Development: Regulatory Overview, Food, Drug, & Medical Device Law,
Biologics Development: Regulatory Overview, Adv. & Promo of Drugs and Medical Device Products,Clinical Drug
Data Analysis.
University ofMemphis Memphis, TN
Master of Science in Organic Chemistry,GPA: 3.3 (4.0) December 2001
Relevant Courses: Inorganic Chemistry, Advanced Instrumental Analysis, Intermediate Organic Chemistry,
Heterocyclic Chemistry, Advanced Organic Chemistry, Physical Chemistry, Advanced Physical Chemistry, Synthetic
Organic Chemistry, Advanced Analytical Chemistry, Approximate Chemical Modeling Methods.
Activities:
 Research Assistant – Studied molecular design and molecular recognition of xanthine based nucleosides
leading to the isolation and characterization of xanthine nucleosides.
 Teaching Assistant – Taught general chemistry and organic chemistry labs.
 Coordinated laboratory materials, conducted lab sessions, and graded lab reports.
WORK EXPERIENCE
SUPRA SCIENCES Atlanta, GA
Technical Sales Scientist June 2015 – Current
 Handled Company accounts as a direct line to sales and technical support.
 Helped to support regulatory compliance throughout the organization.
 Travelled to large pharmaceutical companies and academic institutions for company product presentation
and field action activities.

2. CPC SCIENTIFIC Sunnyvale, CA
Technical Sales Account Manager March 2013 – May 2014
 Managed company’s peptide and research product portfolio.
 Performed other job related duties as required, e.g. managing company accounts.
 Updated and analyzed strategic accounts within the territory.
 Established relationships with clients through phone conversations and compiled a list of valuable accounts.
Utilized interpersonal and communication skills to develop these relationships and close the deal.
ANASPEC Fremont, CA
Technical Inside Sales April 2012 – February 2013
 Managed and promoted sales of company’s products; 12,000 catalog proteomics and genomic products
(peptides, antibodies, dyes, assay kits, unusual amino acids, q-PCR),as well as custom made products.
 Coordinated and ensured quality control process by working with QC/QA dept. – compliance with SOP.
 Enhanced organizational effectiveness through inter-dept. relationship (production, purification, QC/QA,
Sales & Marketing departments). Worked with multi-national individuals and companies.
 Supported the implementation of regulatory activities throughout the facility.
NOVABAYPHARMACEUTICALS Emeryville, CA
Senior Research Associate March 2008 – September2011
 Produced a series of N-Chloroamine analogs (Aganocide) for biological screening and stability leading to the
identification of highly broad-spectrum biological activity with excellent stability profile.
 Participated in drug design and syntheses of different classes of Anti-infective such as LpxC, DNA Ligase
and Oxazolidinone compounds, which resulted in excellent antibacterial activity.
 Co-inventor of key patents for Aganocide compounds with NovaBay Pharmaceuticals.
CHEMOCENTRYXPHARMACEUTICALS Mountain View, CA
Senior Associate Scientist August 2007 – March 2008
 Produced first lead series that validated the project, leading to the discovery of highly potent CCR2
chemokine receptors.
 Identified early generation of biologically-active chemokine receptor compounds for screening purposes with
improved CYP and PK profile by multi-step organic synthesis.
SUNESIS PHARMACEUTICALS South San Francisco, CA
Staff Research Associate II December 2005 – July 2007
 Contributed in design and synthesis of novel kinase inhibitors (Aurora, RAF and BTK) for anti-cancer and
anti-inflammatory agents.
 Produced key leads with improved potency and safety.
PFIZER INC. / VICURON PHARMACEUTICALS Fremont, CA
Scientist III March 2003 – November2005
 Co-invented key patent on the novel Ramoplanin derivatives possessing antibacterial activity.
 Independently designed and implemented multi-step synthetic syntheses of key lead compounds.
 Prepared and purified modified natural products (Polymyxin B, Ramoplanin and Pleuromutilin) improved in
toxicity profile and biological activity.
Scientist II November 2001 – February 2003
 Contributed to pre-clinical discovery of novel anti-infective drugs, including antibacterial (Ramoplanin,
Pleuromutilin) and antifungal (Polymyxin B) projects.
 Analyzed and prepared compounds for screening by multi-step organic synthesis that included the lead
compound identification in the project.

3. RELEVANT SKILLS
 Languages: Fluent in English and Korean.
 Computer skills: Proficient in MS Word, Excel, PowerPoint, MS Project, Beilstein Cross Fire, Sci-Finder,
Reaxys, ISIS and Discovery Gate, Sales Force, CRM.
 Laboratory instrumentation: GC/MS, LCMS, IR, UV/VIS,NMR, TLC, HPLC.
SELECTED PUBLICATIONS, PATENTS ANDPRESENTATION
Available upon request.
AWARDS
Outstanding Performance Award for the delivery of the breakthrough Ramoplanin and LpxC project leads
Vicuron Pharmaceuticals, 2002.
REFERENCES
Hardwin O’Dowd (Research fellow at Vertex) hardwin@hotmail.com (203) 824-3195
Rakesh Jain (Sr. Scientist at Ardelyx Pharma) rjain1956@gmail.com (510) 703-0642
Tim Shiau (Scientist at Verseon) tpshiau@yahoo.com (510) 508-9898
STATUS: US Permanent Resident seeking U.S. citizenship