Post Job Free
Sign in

Customer Service Development

Location:
Silver Spring, MD
Posted:
June 14, 2013

Contact this candidate

Resume:

TAKEISHA LYNNETTE FARMER

***** ******* ******, *******, ** 20902

Phone: 317-***-**** E-mail: ********.*******@*****.***

Profile

Strong analytical chemistry, genetics, and molecular biology background.

Drug development and pharmaceutical manufacturing validations experience

with global pharmaceutical, biotechnology, and CRO industry leaders.

Experience in SOP development, CAPA process, research protocol development,

IRB, GLP, GCP, cGMP (Part 210/211), USP, LIMS, ISO standards, statistical

analysis with project management expertise, FDA and ICH regulatory

experience, effective oral and written communication skills. SOCRA and

RAPS affiliations.

Education

M.S, Anatomy and Cell Biology, Indiana University-School of Medicine

December 2011

Undefended M.S. Chemistry, Tennessee State University, Nashville,

TN Aug'03-May 05

B.S. Health, Physical Education, and Recreation, Tennessee State

University, Nashville, TN May 2003

professional EXPERIENCE

Senior Research Associate

Meharry Medical College/Ob/Gyn Department, Nashville TN

Oct '11-Dec '12

My main role was to assist the principle investigator in biomedical

research resulting in scientific publications and grant funding by engaging

in all aspects of research and evaluation, providing oversight to various

projects, collecting, organizing, and analyzing data, as well as project

planning and managing.

Identify or design appropriate experimental study designs using both animal

and human sample models and samples

(clinical and non-clinical study designs) Techniques: RT-PCR, qPCR,

ELISA, western blot, cell culture, IHC

Patient recruitment, qualification, enrollment for translational research

studies, maintain informed consent and enrollment compensation

documentation.

Assist in the management of study budgets, purchase orders, requisitions,

track study supplies, assist in the development of training tools for

affiliates and investigator site.

Assist in preparing protocols, manuscripts, research proposals, research

and evaluations plans for publications, Institutional Review Board

(IRB), and grant funding sources.

Design data collection forms, liaising with doctors, nurses, and

researchers, study center set-up, archiving study correspondence and track

communication documentation.

Laboratory Technician

Wishard memorial Hospital, Indianapolis, IN

Jul'08- Apr '11

My main role was to assist in patient healthcare by providing assistance

and support to medical technologist.

Receive laboratory specimens from hospital floors and outpatient clinics.

Prepare samples for in house testing and specimens to be sent to reference

laboratories.

Respond to physician and nurse inquiries and resolve questions and concerns

regarding patient lab results.

Work with other lab departments to provide excellent customer service and

patient care.

Identification, labeling, and distributing laboratory samples to

appropriate areas, data entry, routine instrument checks and other

duties as assigned.

Validation scientist, Immunology/biomarker services

covance central laboratories services (CCLS), indianapolis, IN

Jul'07-Jun'09

My main role was to perform validations and validation consultation across

CCLS and to pharmaceutical clients. Primarily performed new test

feasibility and assay development for Phase I-III clinical trials to be

used as an early indicator of patient response to therapeutic intervention.

GCP, GCP/ICH, CFR training, SOP writing and development training.

Serve as a scientific resource for new projects by giving expert advice on

assay feasibility and developing a method validation experimental

plan, and projecting clear time lines for deliverables.

Designing (antigen selection, antibody production, assay development) new

assays or using an assay desired by the client, complete assay

validation, and predict the turn around times and ensure timely

deliverables.

Write detailed standard operational procedures (SOP) and protocols upon

completion of assay validation, train medical technologist to perform the

assay, and ensure smooth transfer to production.

Create training documents and provide departmental training for new or

reformulated analyte testing kits and automated panels.

Ensure compliance for 'Clinical Laboratory Improvement Amendments' (CLIA)

guidelines as required by College of American Pathologists (CAP).

Work with several pharmaceutical companies in the US, Europe and Japan as

our clients.

Validation scientist

roche diagnostics Contractor via Rockwell Automation, Indianapolis, IN

Jan'07-Jul'07

Using knowledge of GCP, cGMP (Part 210/211), FDA regulatory requirements in

the biopharmaceutical industry:

Write, execute, and validate Analytical Test Methods to assess

Product safety, performance, stability, and reliability according to

USP/EP/JP

Control manufacturing processes.

Test and inspect safety, performance, and/or quality characteristics of

materials or components that come in direct contact with the product

throughout its shelf life.

Batch record review and compliance

Create method validation protocols and reports to be used for internal and

external audits.

Associate Scientist

ABC Laboratories, Columbia, MO

Sept'05-Jan'07

Support pharmaceutical companies by providing cGMP analytical

methods development and validations per FDA/ICH

guidelines covering all stages from raw materials, APIs and

finished products according to USP/EP/JP compendias.

Extensive use of HPLC, GC, UV, IR, IC instrumentation as well as

dissolution/time release apparatus.

Instrumentation calibration/preventative maintenance, and troubleshooting.

Generate and review validation reports as well as maintain accurate and

organized documentation of analyse.

Knowledge of IND/ANDA/NDA submission processes.

1 publications

Thota, C, Farmer T, Garfield, R, Menon, R, Al-Hendy A. "Vitamin D elicits

anti-inflammatory response, inhibits-contractile associated factors and

modulates toll-like receptors in human myometrial Cells" Reproductive

Sciences 2012 Sept.

Niziolek P, Farmer T, Cui Y, Warman M, Turner CH, Robling A. "High-bone-

mass-producing mutations in the Wnt signaling pathway results in distinct

skeletal phenotypes." Bone 2011 Nov;49(5):1010-9.

Williams J, Sacks A, Englert K, Deal R, Farmer T, Jackson M, Lingeman J,

McAteer J

"Stability of the infection marker struvite in urinary stone

samples." J Endourology. 2012 Jun;26(6):726-31.

Chaturvedi S., Farmer T., Kapke G. F. "Assay Validation for KIM-1: Human

urinary renal dysfunction biomarker". International Journal of Biological

Sciences 5 (2009) 128-134.

Cosmos, O. Okoro, Olugbeminiyi, O. Fadeyi, Patrice L. Jackson, Rhonda L.

Richmond, and Takeisha Farmer. "Synthesis of fluorinated cyclic s-trans

vinylogous acid and amide ester derivatives", Tetrahedron Letters 47 (2006)

7451-7454.

2 presentations

Takeisha Farmer, A. Archibong, 2012 "Resveratrol restores fertility indices

in BaP treated male rats" at Tennessee Physiological Society Meeting,

Nashville, TN.

Takeisha Farmer, A. Robling, 2011 "Inducible Deletion of B-Catenin from

Osteocytes In Vivo" at National Histochemical Society Meeting, Marine

Biological Laboratories, Woods Holes, MA

Chaturvedi S. Farmer T., Kapke G.F., Turi T., 2009 'Kidney Injury Molecule-

1: Biology and Analytical Validation', at Institute for International

Research Conference, Las Vegas, Nevada

Takeisha Farmer, C.O. Okoro, Ph.D., 2005 'Synthesis, Conformational

Analysis and Molecular Properties of Methyl-4- [(Substituted-

phenyl)amino]-2-oxo-6(trifluoromethyl)cyclohex-3-ene-1-oates', at ASC

Southeast/Southwest Regional Meeting, Memphis, TN

Professional organizations and committees

Regulatory Affairs Professional Society

Society of Clinical Research Associates (SoCRA)

Tennessee Physiological Society

Histochemical Society

Histochemical Society Awards and Membership Committee 2010-2011

National Histochemical Society Student Travel Award Recipient 2010, 2011,

2012

National Histochemical Society Ralph D. Lille Award Recipient 2011 for best

student oral presentation $2000

Sigma Gamma Rho Sorority, Incorporated

1 references

Fred Hamilton Tel# 317-274-

1939

Indiana University-School of Medicine

Email: ********@*****.***

Kristen Hosey, PhD Tel# 601-918-

6812

Indiana University-School of Medicine

Email: ******@*****.***

Nicole Corner Tel# 317-***-****

Covance Central Laboratories Email:

******.******@*******.***

Donald Muathe Tel# 913-***-****

Aptuit Email:

******.******@******.***



Contact this candidate