[jsfg_cinti] Job Posting: Director of Bioanalytical Methods Development - NC

The following job opportunity has been posted to the JSFG E-mail Mailing List 
by 
JSFG@xxxxxxxx on April 7th, 2004 at 12:11PM (CDT).

Date: 04/07/04
JobTitle: Director of Bioanalytical Methods Development - NC
JobClass: Manufacturing Operations
JobDescript: Director of Bioanalytical Methods Development - NC

A client of ours located near Research Triangle Park, N.C., is seeking a 
talented Director of Bioanalytical Methods Development . They are a rapidly 
growing biotech vaccine company that is developing a new generation of human 
vaccines based on a unique viral vector delivery system. The vector system 
constitutes a major advance in vaccine technology and has the potential to 
exert a significant influence on the future course of the vaccine industry. 
Immediate applications of the technology include a variety of preventative and 
therapeutic vaccines for infectious diseases and cancer.

OVERVIEW

Direct, manage and participate in the development, qualification and validation 
of analytical and bioanalytical methods used for product characterization, 
process development and QC in-process and release tests for viral vaccine 
clinical supplies. Develop methods to assist in process development activities. 
Manage vaccine substance and product stability testing in support of clinical 
lot production. Assure that testing is performed according to current 
regulatory guidelines. This position will coordinate activities across relevant 
functional areas and may handle other non-technical administrative duties on a 
limited basis.

Responsibilities

Tutor, train, and advise colleagues in areas related to analytical sciences. 

Assure activities are conducted in accordance with corporate procedures, SOPs, 
GLPs and GMPs 

Serve as a technical representative and/or technical lead on projects and 
coordinate project activities with other functions. 

Estimate resource requirements in order to determine cost estimates for 
projects included in proposals. 

Maintain a high level of scientific excellence by regularly attending national 
and regional technical meetings and presenting technical work whenever the 
opportunity arises. 
Location: RTP, NC
Requirements_Qualif: Qualifications 

The position requires a Ph.D. in Virology, Biochemistry, Chemistry, 
Microbiology or related discipline plus 8+ years of biological/pharmaceutical 
development experience, preferably in an analytical development role. 

The successful candidate should be highly skilled in methods of viral vaccine 
analysis (plaque assays, cellular DNA/protein contaminants), recombinant DNA 
techniques (Southern, Western blots), standard immunochemical methods (ELISA, 
IFA), and FDA (CBER) requirements for vaccine release (adventitious agent 
testing, CFR methods) and analytical skills 

Advanced knowledge for the development, qualification and validation of 
bioanalytical methods used in vaccine development. 

Solid knowledge of GLP, and GMP requirements for vaccine development. 

Possess a strong fundamental and working knowledge of pre-clinical and 
biological/ pharmaceutical sciences, and knowledge of instrument analysis. 

Ability to develop, implement, and troubleshoot analytical methods. 

Possess strong verbal, written communication and organizational skills. 

To be considered for this position, please submit your resume in Word format to 
resumes@xxxxxxxxxxxxxxxxxxxxxxxx Please also include compensation expectations 
and a cover note addressing the specific qualifications you hold relating to 
the job description.

Thank you for your time - have a great day!
WorkType: Full-time Regular
Travel: No
PositionState: Existing
SalaryRange: $
HowApply_Email: Yes
Company: Work Wonders Staffing LLC
Person_Requesting_Profiles: Michael Wilmarth
Contact_StreetAddress: 4107 East Woodstock Road
Contact_City: Cave Creek
Contact_State: AZ
Contact_ZipCode: 85331
Contact_WorkPhone: 480-000-0000
e-mail: resumes@xxxxxxxxxxxxxxxxxxxxxxx
email: JSFG@xxxxxxxx
bgcolor1: #FFFFFF
Cutoff: 07/01/04
Submit: Submit Form


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