QIUXI FAN Ph.D.

1819 Leithsville Rd.

Hellertown, PA 18055
(973) 493-6459
E-mail: qxf1512@njit.edu, qiuxi_fan@yahoo.com

Summary of Qualifications

- Highly motivated scientist with strong problem solving skills, comprehensive knowledge in
multiple dosages formulation, characterization and supervisory experience.
- Practical experience in topical pre-formulation, formulation, permeability (IVPT) & in vitro
release testing (IVRT) and its related bioequivalence (BE), biowaiver issues
- Leadership experience in pre-formulation, IVRT method development, validation and
comparison study under cGMP environment.
- In-depth knowledge of Regulatory Guidelines (FDA, ICH, USP), and all aspects of
laboratory GXP requirements.
- Consistently delivered results that exceeded expectations.
- Excellent communication skills and strong ability to work in teams and collaborations.

Professional Experience

PermeGear, Inc., Hellertown, PA

Position: Consultant, R&D CRO lab Sept. 2016 Date

G&W Laboratories, Inc., South Plainfield, NJ

Position: Group Leader / Sr. Scientist, Analytical Tech Sept. 2014 - Aug. 2016
- Supervising and guiding junior scientists on IVRT's method evaluation, optimization
(through QbD), validation using Franz diffusion cells and HPLC.
- Managing all IVRT projects' method development, validation and comparison study for
approvable FDA filings: Assigning, scheduling and coordinating projects; Mentoring junior
scientists; Troubleshooting problems arisen in each project.
- Successfully responded to FDA's deficiency letters on IVRT/BE and FDA's on-site
auditing request with no 483 issued; 2 products approved by FDA with no BE issue
raised.
- Led and guided CRO's research work to approved FDA filings.

PermeGear, Inc., Hellertown, PA

Position: Principal Scientist, R&D Nov. 2010 Sept. 2014
- Managed full development of novel diffusion system design, testing & application for
topical/transdermal drug delivery (TDD) as well as IVRT & IVPT.
- Managed and supervised customers applications of PermeGear products including
training, consulting, method development, etc.
- Research focused on pre-formulation (solubility profile, API partition coefficient) &
formulation phases by QbD (JMP) along with characterization

Particle Sciences, Inc., Bethlehem, PA

Position: Group Leader / Sr. Scientist, R&D Nov. 2006 Nov. 2010
- Responsible of full development of projects for semi-solid products from pre-formulation
characterization of the APIs: antiretroviral agents, microbicides, peptides, etc.(mostly of

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 poor water solubility), formulation development by QbD (JMP) & characterization, support
of preclinical & clinical trials, scale-up, and technology transfer to client companies.
- Interfaced with analytical services as well as QA for testing of excipient compatibility, raw
material physical & chemical analysis, and API & product stability under cGMP
environment.
- Supervised and managed method development and validation of IVRT under GLP
environment as well as IVPT.
- Drafted and reviewed SOPs for formulation development and characterization method.
- Led application of computing chemistry in the formulation development of multiple
dosage forms: SPARC, Hansen solubility parameters, etc.
- Regularly wrote up technical summary reports and presented project progress within the
company as well as to the clients.
- Managed, guided and trained junior scientists on daily activities.
- Led multi-projects (3-5) simultaneously and successfully in a dynamic CRO environment.

New Jersey Institute of Technology, Newark, NJ

Position: Consultant, Lab for Drug Delivery & Biotechnology Jan. Nov. 2006

Dermik Laboratories, Dermatology Division of Sanofi-Aventis, Berwyn, PA

Position: Scientist, Pre-clinical characterization & formulation Feb. Dec. 2005
- Developed innovative and/or line-extension dermatological products, which involves
formulation evaluation.
- Independently designed, implemented and interpreted NCEs pre-formulation studies
such as physicochemical characterization, percutaneous permeability, stability evaluation
and salt screening by pSOL G (solubility, pKa, LogP/D), TGA/DSC (thermal properties),
HPLC (Empower) under cGMP.
- Prepared and issued development protocols documents that lead to approvable CMC
dossier for new compound registration.
- Created SOPs, IQ/OQ/PQ and DQ protocol documents for lab instruments as well as
designing and executing validation plan for them.
- Prepared technology disclosures (CDA, IDM, etc.) for licensing and NDA, patent filings.
- Coordinated studies with contract research laboratories.

Projects involved:
- Subcutaneous treatment of obesity
- New compounds screening for acne treatment
- Ketolide antibiotics for topical delivery

Vyteris, Inc., Fair Lawn, NJ June-Aug. 2003

Position: Intern Scientist/Engineer
- Performed in vitro & in vivo iontophoretic transdermal patch research including IVPT,
HPLC analysis, in vivo pig study, etc.
- Prepared the in vitro test protocol of iontophoretic transdermal patch for the FDA filing.

Education

Ph.D. (Materials Sci. & Eng.), New Jersey Institute of Technology, Newark, NJ
M.E. (Mechanical Eng.), Beijing Institute of Light Industry, Beijing, China
A.E. (Chemical Eng.), Anhui College of Mechanical & Electrical Engineering, Wuhu, China

Skills

Analytical: UHPLC, FTIR, DSC/TGA, SEM, Particle sizing characterization; Diffusion Cells
Softwares: Empower, JMP, SPARC, HSPiP; Word, Excel

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Consecutive Interpreting: Ch-En

Selected Publications & Presentations

Qiuxi Fan, K. K. Sirkar, Jing Wu, A thermo-sensitive release system based on polymeric
membrane for transdermal delivery of doxycycline HCl, Journal of Membrane Science,
337 (2009), 175-181.
Qiuxi Fan, K. K. Sirkar, B. Michniak, Iontophoretic transdermal drug delivery system using a
conducting polymeric membrane, Journal of Membrane Science, 321 (2008), 240-249.
Qiuxi Fan, M. Mitchnick, A. Loxley, The issues & challenges involved in IVRT for semi-solid
formulations, Drug Delivery Technology, 7 (2007), 9, 62-66.
Qiuxi Fan, K. K. Sirkar, Y. Wang, B. Michniak, In vitro delivery of doxycycline hydrochloride
based on a porous membrane-based aqueous-organic partitioning system, Journal of
Controlled Release, 98 (2004), 3, 355-365.
Y. Wang, Qiuxi Fan, et al., Effects of fatty acids and iontophoresis on the delivery of midodrine
hydrochloride and the structure of human skin, Pharmaceutical Research, 20 (2003),
10, 1612-1618.
Y. Wang, R. Thakur, Qiuxi Fan, et al., Transdermal Iontophoresis: Combination Strategies To
Improve Transdermal Iontophoretic Drug Delivery, European Journal of Pharmaceutics
and Biopharmaceutics, 60 (2005), 2, 179-191.

Qiuxi Fan, K. K. Sirkar, Transdermal delivery of doxycycline HCl base on three different release
systems, Podium presentation, 2009 North American Membrane Society (NAMS)
Annual Meeting, Charleston, SC
Qiuxi Fan, K. K. Sirkar, B. Michniak, Iontophoretic transdermal drug delivery system using a
conducting polymeric membrane, Podium presentation, 2008 AIChE Annual Meeting,
Philadelphia, PA

Patents

U.S. Patent No. 8,036,738, Iontophoretic Transdermal Drug Delivery System Based on
Conductive Polyaniline Membrane.
U. S. Provisional Patent Application No. 60/775,617, A Thermo-Sensitive Release System Based
on Polymeric Membrane for Transdermal Drug Delivery.

Reviewerships

- Journal of Controlled Release

Membership

- AAPS

Certificate

- Graduate Certificate in Consecutive Interpreting, Ch-En (UMD)