Jim Crumpley & Associates

• Job ID:AFF-200
• Date:11/12/2008
• Location:Midwest
• State:Missouri
• Degree:B.S./B.A.
• Major:Science/Engineering
• Current Professional Level:Sr. Manager/Manager

Salary Range:$150,000+

This salary range was selected from the CareersInPharmaceutical.com salary data list. See the "Additional Salary" or contact the Recruiter for actual salary and benefits.

Additional Salary/Compensation:

Bonus Eligible

Job Types:

Batch Records, Tech Services/Scale-up/Product Commercialization, Validation

POSITION OVERVIEW --Seeks a Director, Operations Excellence who will direct and manage all aspects of master batch records for bulk manufacturing from “R&D Draft” stage to final approval. The successful candidate will have experience managing the technical transfer process from the operations perspective, can provide assistance and technical expertise in preparation and execution of scale-up and submission batches, and can manage process validation program from operations perspective. The Director will be an individual who will manage the technical aspects of NCR investigations from operations thru execution of rework/reclamation processes; represent the interests of Manufacturing/Operations in robustness of products; works with Scientific Affairs department from early stages of product development; advises Pharmaceutical Division management on product development issues and possible resolutions; oversees and directs all activities for technical investigations and trouble-shooting for product/ production issues; directs and summarizes the review of all data, records, and procedures related to the discovery of product/production issues; and follows Change Control Procedures to issue any corrective and preventive actions. --The Director, Operations Excellence will also assist the Department Managers and Supervisors in initial production lots of all new products and advise Pharmaceutical Division management on new and emerging PAT (Process Analytical Technology) for incorporation into R&D and production programs. QUALIFICATIONS --The ideal candidate will have a B.S., M.S., or Ph.D. in Industrial Pharmacy, Pharmaceutics, Chemical Engineering, or related science area. The Director must have excellent written, verbal, and interpersonal communication skills; be highly organized and detail oriented. A minimum of five years of experience in management roles within pharmaceutical industry, most desirable in Quality Assurance and/or Research and Development is required. We are seeking an individual who can multi-task, prioritize, and is proficient in Microsoft Office.

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