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Vacancy in Analytical Development at Nektar Therapeutics

 

Clinical courses

Conceives experimental strategies and leads and participates in the design and conduct of experiments in biological systems to characterize and validate novel targets and test efficacy of potential therapeutics to prioritize them for further development in a variety of disease areas. Possesses knowledge of relevant experimental biology techniques, possibly including: molecular biology techniques, in vitro binding, biochemical and cell- based assays, cell culture, pharmacologic dosing, disease model testing, PK and metabolism methodologies.  Participates in technology development in the area of in vitro assays, cell biology or in vivo testing.

Post : Analytical Development

Position Summary:
Directs the activities of an analytical development group in the research and/or development of an organization's products, projects and programs. Conducts and collaborates with others on analytical chemistry issues relevant to long-term objectives and concerns. 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. May develop budgets for capital expenditures and 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.

Responsibilities:
Works on complex problems in which analysis of situations or data require an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules and performance requirements are met. Regularly interacts with senior management. 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 Ph.D degree in a scientific or engineering discipline is required.  Equivalent experience may be accepted. A minimum of 10 years experience in the pharmaceutical or other technology based product research, development or manufacturing industry is required. A minimum of 8 years previous management experience is required. Must have a proven track record of managing and advancing both groups and projects in a technology based industry. Expertise in pharmaceutical research /development as well as compliance with regulatory guidelines, good documentation, safety practices and GMP/GLP requirements/practices. Extensive knowledge and demonstrated experience in chromatographic (HPLC and GC), spectroscopic (UV, IR) and wet chemistry techniques as well as specialized techniques such as LC-MS and NMR.  Must be able to demonstrate success in technical proficiency, scientific creativity, collaboration with others and independent thought. Prior experience with regulatory filings (US IND/BLA/NDA, European IMPD/BLA/MAA) and regulatory agency interactions highly desireable.  Experience with both small molecule and large molecule R&D projects highly desirable. Must be able to clearly communicate scientific information both written and oral. 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. Must be willing to work as part of a team and demonstrate good interpersonal skills.  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/manage to a budget and attract top talent is a must. Must be goal-oriented, quality-conscientious, and customer-focused. 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.

Additional Information:
Location: Hyderabad, India
Job ID:   IN3104-3452-R
Area of Interest:  Research
Job Type:    Full-Time

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