Search Jobs: Results: Director - Pharmaceutical Development
This Director role will contribute to, manage, and/or oversee analytical sciences and technology support for pharmaceutical development for pre-clinical through IND submission and early phase clinical studies, which may include analytical support of:
* Drug substance(DS) manufacture, characterization, in-process control, scale-up, reference standards, stability and specification development
* Knowledge of high-throughput purification systems, processes, and data analyses to purify combinatorial libraries
* Supervise development of appropriate analytical methods and improvement of existing ones to support the appropriate stage of drug development
* Manage analytical support and provide recommendations when development results in changes to analytical methods
* Establish collaborative working relationships with medicinal chemists and process development groups
* Critical evaluation/interpretation of experimental data for conclusions/resolutions of drug development
* Sets priorities to meet changing needs from multiple projects
* PhD in Analytical Chemistry or related discipline with minimum 15 years pharmaceutical industry experience in GLP/GMP environments or relevant experience (development and application of analytical methods) or related corresponding amount and applicability of experience
* Extensive knowledge of current analytical methodologies for low level impurity ID and quantitation (HPLC and varied detections systems, LC/MS, LS/MS-MS, GC/MS, FTIR, NMR, etc.)
* Thorough knowledge of US and international regulatory requirements (ICH Guidelines)
* Thorough knowledge of GLPs and GMPs as they relate to analytical support
* Experience in mentoring and supervision of staff (must have previous direct management experience of managing groups of at least 10+ for at least 5 years).
* Project management and team leadership skills
* Excellent communication skills
* Demonstrated ability to work on multiple projects and meet timelines
For immediate consideration, please submit your resume in confidence. Due to the volume of resumes received, only those meeting these requirements will be contacted.
Job Details
| Name: | Joanne Gehas | Date Posted: | 11/02/2009 |
| Office: | Raleigh | Telephone: | (919) 848-9929 |
| Email: | jgehas@fpcraleigh.com | Fax: | |
| Category: | Pharmaceutical | ||
| Keywords: | discovery, Purification, medicinal, process chemistry, organic chemistry, impurity ID, HPLC, NMR, LC/MS | Region: | |
| State: | NC | City: | |
| Education: | PhD | Job Number: | J42831-RALE- |
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