Director of Analytical Development - Boca Raton, FL | Biospace
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Director of Analytical Development

Biotest Pharmaceuticals Corporation

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Location:
Boca Raton, FL
Posted Date:
5/4/2017
Position Type:
Full time
Job Code:
846
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Analytical Chemistry, Biotechnology,

Job Description

To lead a dynamic analytical team responsible for the key lifecycle elements of compendial and non-compendial analytical, biological, and microbial test methods used in the cGMP analysis of drug substance, drug product, manufacturing process intermediates, and raw materials of plasma-derived products. To assure all departmental activities are conducted in alignment with current and emerging regulatory expectations and industry best practices for high quality analytical teams. To provide sound technical and quality guidance to the organization for classic and emerging methodologies applicable to QC testing and other corporate projects. To serve as a senior liasion to QC and QA operations and management, and facilitate meaningful, productive interactions between the analytical group and these departments.

Requirements

This position requires a Ph.D. in biochemistry/analytical chemistry or equivalent related science. Ten (10) or more years extensive method development and validation experience in Biologics industry. Five or more years in management/supervisory role within cGMP pharmaceutical environment. Experience in transfer of assays between laboratories and establishment of new labroatories meeting Biosafety Level 2 requirements is essential. Good communication skills - both written and verbal. Strong knowledge of Biochemical principles. Ability to use personal computer with software including word processing, graphics, statistical analysis, and database. Knowledge of ICH and compendial validation guidelines as well as internal SOP's. Experience in GLP and GMP requirements. Knowledge of USP and Eur. Ph. .