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Miles
Km80.5

Sr. Director, Analytical Development

Nektar Therapeutics

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Location: Huntsville, AL Posted Date: 4/9/2013 Position Type: Full time Job Code: 2741-395-R Required Education: Bachelors Degree Areas of Expertise Desired: Analytical Chemistry
Manufacturing/Production
Regulatory Affairs
Research

Description

Lead and direct the activities of Analytical Development department in the Nektar Pharmaceutical Development and Manufacturing organization. Responsible for product characterization, analytical method development, process development support and Regulatory filing of IND/NDA/MAA documents. Develops and directs testing methodologies to control raw materials, production intermediates, API and finished products. Develops strategies to ensure effective achievement of scientific objectives. Monitors and evaluates completion of tasks and projects. Develop budgets for capital expenditures and project labor. Typically participates with other top managers to establish company policies. Makes final decision on administrative or operational matters. Selects, develops, and evaluates personnel to ensure the efficient operation and cGMP compliance of the function. This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities
Consistently works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas through assessment of intangible variables. Interacts internally and externally with executive-level management requiring negotiation of extremely difficult matters to influence policymaking bodies.   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. Hires and trains staff at appropriate levels of need, coordinates annual reviews, and counsels junior staff on career related subjects. Provides scientific/technical guidance, leadership and decision-making as appropriate. Provides regular performance feedback, development and coaching to direct reports.  Maintains a thorough working knowledge of and champions the efficient execution of cGMP, as related to analytical activities in the pharmaceutical industry.


Requirements

A minimum of a Bachelors degree in a scientific or engineering discipline is required.  A PhD is highly desired, equivalent experience may be accepted.  A minimum of 15 years experience in the pharmaceutical or other technology based product research, development or manufacturing industry is required.  A minimum of 12 years previous management experience is required. Expertise in pharmaceutical research /development and cGMP is a must. Experience in writing scientific and regulatory documents is required. Prior experience with NDA/MAA filings and regulatory agency interactions highly desirable.  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 external. Understands how to set expectations and negotiate proper milestones to track progress. Must have strong negotiation and influencing skills.

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