Associate Director, Analytical Chemistry

Employee Type :  Full-Time Industry :  Biotechnology
Pharmaceutical Manages Others :  Not Specified Job Type :  Biotech
Pharmaceutical Education :  Graduate Degree Experience :  7 to greater than 15 years Post Date :  5/22/2012 Contact Information Contact : Colby Wexler  Description Supervise and provide guidance to scientists who analyze excipients, drug substances, drug products, packaging components and stability samples in support of new product development and product transfer.  Lead development and validation activities for a variety of analytical methods including assay, degradation, dissolution, and physical characterization techniques.  Lead preformulation and formulation prototype assessments for early phase development candidates.  Lead a CMC team for an early phase NCE through IND filing and beyond.  Work closely with Pharmaceutics, Non-Clinical Project Teams, QC, the manufacturing sites, and other customers to provide analytical input and support.

PRINCIPAL ACCOUNTABILITIES

• Direct method development, validation and transfer to manufacturing site to support all phases of new product development.
• Maintain knowledge of the overall drug development process, the managerial ability to coordinate the efforts of multiple departments towards a common goal, and effectively represent multiple departments at the core team level.
• Direct preformulation activities and analysis of prototype formulations.  Evaluate the physicochemical properties of active ingredients and excipients used in dosage form development.
• Understand and comply fully with GMP regulations and ICH guidance’s.  Understand FDA expectations and communicate directly with the agency when needed.
• Lead a CMC team for an NCE through IND filing and beyond.
• Supervise analysts; including professional development, work assignments, productivity, and integrity and quality of their output.
• Assure the integrity of all data generated.
• Coach, provide constructive feedback, handle personnel issues, and set priorities as needed for direct reports.
• Write and review analytical documents including SOPs, INDs, NDAs, test methods, calibration procedures, etc.  Provide responses to FDA questions and interact with FDA reviewers as needed.
• Evaluate and recommend new methodologies and technologies to improve productivity and efficiency in the analytical laboratory.  Requirements

Educational Requirements

This position requires a MS degree in Chemistry or equivalent with 10

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