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2007-01-25: Talents with Experience of Submitting ANDA (injection) to FDA Wanted, Hsinchu, Taiwan

The position is based in Hsin-chu, Taiwan.

Our client, a biotech company based in Hsin-chu, Taiwan (headquartered in Long Island, New York), 
is looking for talents with solid experience in submitting ANDA (injection) to FDA for the approval 
of generic drugs.   

Key responsibility:
Submitting ANDA (injection) to FDA
Leading a research team of 4 to 5 people

Qualification:
	More than 10 years working experience in pharmaceutical industry
	Several years experience of submitting ANDA (injection) to FDA
	Master degree or above
	Excellent English communication skills; Bilingual in Chinese a big plus
	Aggressive, proactive attitude, team player
	Candidates of all ages and nationalities are welcome to apply. 

Compensation:
To be discussed, but compensation will top the candidate's current package.


For immediate consideration, please send a Word version of your resume in English (and Chinese, if any)
to yachi@360d.com.tw 
Important: the subject field of your email must include 
 FDA ANDA (injection) - Taiwan 
or call tel: 886-2-2100-2625 #899  Ms. Ya-chi Tsai for more information

2006-07-21: Senior Analytical Development Opportunity in the Bay Area

www.nsasearch.com

RESPONSIBILITIES: Develop and validate analytical methods and provide analytical testing support for development activities. Responsibilities involve all aspects of analytical support for drug substance, drug products and devices and includes conducting analytical activities, coordination of activities with other internal departments, and interaction with contract laboratories and manufacturing sites, as required. Develop and validate analytical methods. Conduct analytical testing in support of GMP studies. Provide analytical testing support for a variety of development projects. Travel to contract sites, as necessary, to facilitate method transfers and validations. Generate analytical data and reports needed for the CMC section of INDs, NDAs and other regulatory filings. Assist in the establishment of internal capabilities for analytical development. Assist in the development of standard operating procedures governing the analytical function. Perform routine maintenance and calibration of laboratory equipment.

REQUIREMENTS: BS, MS, Ph.D. degree in chemistry. At least 6 years of experience in pharmaceutical development for PhD, MS with 8 years and BS with 10 years. Experience with method development and validation related to the testing of active pharmaceutical ingredients, drug products and devices in a GMP environment. Familiarity with analysis of large peptides or small proteins is desirable. Experience dealing with contract laboratories is a plus. Knowledge of analytical requirements for parenteral and oral products. Experience using HPLC, GC, ion chromatography, dissolution, spectrophotometry, and other laboratory techniques is required. Experience with controlled release products is desirable. Experience with Phase II/III product development is necessary. Prior experience with approved NDA products is a plus. Good writing and interpersonal skills. Prior experience writing CMC sections of filings is a plus. Ability to negotiate and deal with others in a constructive manner and adapt quickly to quickly changing timelines.

2006-06-15: Research Associate II/III and Group Leader Analytics/QC

My clients in CA and in ND have the following openings, please
call to discuss or please email your resume. I look forward to our next
contact. Regards, Anita Mascoll Associate - Life Sciences Group
Sterling-Hoffman Executive Search
(T) 888.636.4802 Ext. 228
(F) 416.979.3030
anita@sterlinglifesciences.com
www.sterlinglifesciences.com
www.sterlinghoffman.com