Director, Bioanalytical

Duties:

Directs bioanalytical activities in the research and/or development of an organization's products, projects and programs. Conducts and collaborates with others on bioanalytical issues relevant to long-term objectives and concerns. Develops and directs state of the art bioanalytical technologies such as, ligand binding assays, bioanalytical and immunogenicity methods, metabolite identification for analysis of large molecules in biological fluids and tissues to support drug discovery, preclinical and clinical development. Develops strategies to ensure effective achievement of scientific objectives. Monitors and evaluates completion of tasks and projects. Makes recommendations for final decision on administrative or operational matters. Supports management of external contract laboratories when needed to provide non-GLP and GLP bioanalytical data. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Job Duties

• Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables.
• Interacts internally and externally with executive level management requiring negotiation of
• Implements established and newly developed technologies in current and future generation products.
• Integrates and maximizes the contribution of science and technologies to the development process.
• Establishes goals, structures experiments, analyzes and reduces data, recommends and plans actions to achieve project objectives.
• Works in conjunction with functional teams to transfer and implement science/technology.
• Communicates cross-functionally with groups such as formulation development, manufacturing and other groups to ensure appropriate project support.
• Maintains a current knowledge of latest technological/scientific trends.
• Provides scientific/technical guidance, leadership and decision-making as appropriate.

Skills:

Experience in writing scientific and regulatory documents is required. Knowledge of advanced statistical techniques, such as data trend analysis and design of experiments, is highly desirable. Strong verbal and written communication skills are required. Project management skills are required. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations. Must have a demonstrated ability to work with senior management. A proven ability to develop and manage to a budget is a must. Must be goal-oriented, quality-conscientious, and customer-focused. Good laboratory compliance and safety practices are a must. Demonstrated ability to develop successful relationships with and influence customers, both internal and

Education:

A minimum of a Bachelors degree in a scientific or engineering discipline is required. An advanced degree is highly desired. Equivalent experience may be accepted. A minimum of 13 years experience in the pharmaceutical or other technology based product research, development or manufacturing industry is required. A minimum of 10 years previous management experience is required. Expertise in pharmaceutical research /development and GLP requirements is required.