Development Scientist II

QIYONG (GARY) XIAN **** ROSE STREET * GOLDSBORO, NC 27530

919-***-**** * ********@*****.***

EDUCATION

CAMPBELL UNIVERSITY SCHOOL OF PHARMACY, Buies Creek, North Carolina. 08/2005 – 05/2008

B.S. in Pharmaceutical Science, May 2008

Concentration GP A: 3.29/4.00, overall GPA: 3.14/4.00

Award Included: Dean’s List (2008), Yates Family Pharmaceutical Scholarship (2007), Presidential Scholarship

(2005 - 2008), Administrative Dorm Scholarship (2005 - 2008)

WAYNE COMMUNITY COLLEGE, Goldsboro, North Carolina. 08/2004 – 07/2005

Enrolled in core associate in science courses with a plan to pursue pre-pharmacy curriculum.

Overall GPA: 3.89/4.00

Award Included: Dean’s list (2004), Academic Scholarship from Kiwanis Club of Goldsboro (2004 & 2005)

WORK EXPERIENCE

METRICS INC. / MAYNE PHARMA, Greenville, NC. 04/2014 – present

Pharmaceutical Development Scientist II – reports to Director, Pharmaceutical Development

Supervise a team of 5 subordinates (3 Specialist II, 1 Technician II and 1 Intern).

Proficient in delegation, for improving efficiency of the group and department.

Maintain no less than 5 active fee-for-service projects from 4 active clients (a total of 14 clients).

Manage internal resource very well to achieve time -critical support for ongoing project activities.

Project leader of 9 clinical registration batches (CII Controlled Substance), supervising commercial group operators

and utilizing commercial equipments.

Construct monthly billing statements to assist Director of Pharm Dev. handling billing issues.

Semi-Annual Evaluation Overall Rating: Exceptional (key comment: “proficient in delegation”)

METRICS INC. / MAYNE PHARMA, Greenville, NC. 09/2011 – 03/2014

Pharmaceutical Development Scientist I – reported to Ass. Director, Pharmaceutical Development

Supervised a team of 2 subordinates (1 Specialist II and 1 Specialist I).

Maintained no less than 4 active fee-for-service projects from 3 active clients (a total of 13 clients).

One of the few lead scientists responsible for Mayne Pharma’s sp earhead, generic drug product (CII) .

Independently designed and executed experiments, analyze data, troubleshoot and effectively communicate

experimental findings to both internal analytical support group and external clients.

Independently hosted teleconferences with domestic and international clients to integrate experiment results into

overall process and product development plans.

Successfully developed formulations and manufacture process for scale-up, tech transfer and CTM manufacturing.

Strong GMP experience in the development and scale -up of the following technologies: encapsulation, tableting,

fluid bed granulation/coating/drying, high/low shear granulation, roller compaction, film/enteric coating, taste

masking, and other supportive processes.

Annual Evaluations Overall Rating: Exceeds Expectations (key comment: “rising star amongst 9 of my staff”)

METRICS INC., Greenville, NC. 08/2009 – 8/2011

Pharmaceutical Development Specialist I – reported to Sr. Formulation Scientist, Pharmaceutical Development

Primary point of contact for clients

Responsible for formulation and process development of immediate and controlled release oral dosage forms for

new drugs (fee-for-service projects).

Worked overtime and modified schedules to meet project deadlines.

Worked closely with internal support groups, such as Analytical Services, Quality Assurance, and Logistics to

ensure projects meet deadlines. Gathered respect from them for my attention to detail and completeness of work.

Prepared formulation development reports, client complaint investigations, SOP’s and CMC sections for regulatory

submissions.

Annual Evaluations Overall Rating: Exceeds Expectations (key comment: “very enthusiastic about learning”)

METRICS INC., Greenville, NC. 06/2008 – 07/2009

Pharmaceutical Development Technician II – reported to Sr. Formulation Scientist, Pharmaceutical Development

Secondary point of contact for clients.

Prepared and coordinated execution of scale-up protocols and CTM batch records.

Manufactured and packaged of development, stability, and federal registration batches with cGMP guidelines

Identified and resolved formulation and process scale-up issues

Co-authored a technical poster with company Vice President (2008 national AAPS conference)

Semi-Annual Evaluation Overall Rating: Exceeds Expectations (key comment: “strenuous level of attention to

detail”)

METRICS INC., Greenville, NC. 01/2008 – 05/2008

Intern – reported to Sr. Formulation Scientist, Pharmaceutical Development

Gained scientific knowledge on various unit operations: Dispensing, Micronization, Blending, Granulation, Milling,

Compression, Coating, Powder Encapsulation and Over-encapsulation.

Experience on various standard USP tests for oral solid dosage drugs (disintegration, dissolution, friability, content

uniformity tests, KF, assay and impurity).

Assisted with batch manufacture and packaging/labeling, including assemble, disassemble, clean and store

equipments.

Internship Overall Grade: A

SKILLS

Laboratory Skills: Analytical techniques including chromatography (HPLC, GC, TLC), spectroscopy (atomic

absorption, UV, VIS, FTIR), CE and gel electrophoresis. Aseptic techniques including isolation, identification and

culture of bacteria and yeast. Molecular techniques including plasmid isolation, PCR, Souther n, Northern, and

Western Blots, and protein purification. Experience gained in USP methodology and instrument validation.

Unit Operation Skills: Powder encapsulation, over-encapsulation, tableting, fluid bed granulation/coating/drying,

high/low shear granulation, roller compaction, film/enteric coating, taste masking, and other supportive processes.

Computer Skills: MS Project, Word, Excel, Access, Power Point, SAS JMP, SharePoint, eRoom, MasterControl,

BMS, and CIMS and Adobe Reader.

PROFESSIONAL TRAINING

Mixonian Institute, Greenville (on-site training), NC.

Certification Training for Supervisors, December, 2013

The Center for Professional Innovation and Education, Inc. Los Angeles, CA .

The Drug Development Process – From Discovery to CommercializationTM, 3-day course, May, 2013

Colorcon, Inc. West Point, PA.

Formulation School, 2-day course, March, 2010

Capsugel University, Greenville (on-site training), NC.

Certification Training on Bohanan Versifil and Bosch 400 Capsule Filling Machines, July, 2 009

HOBBIES

Fishing

Kayaking

Travel

REFERENCES AVAILABLE UPON REQUEST

Contact this candidate