US: Associate Director in biotech

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Date: 10-Feb-2009

Associate Director in biotech

Description Responsible for planning, supervising, and executing a major portion of development activities in the areas of purification process development, optimization, process characterization, scale-up, validation, and technology transfer to clinical / commercial manufacturing. Will lead a purification development team with responsibilities for several projects in various phases of clinical development, including process validation for clinical/commercial processes. Good working knowledge of protein chemistry, protein purification and process design. Experienced with statistical design of experiments as well as identification of critical process parameters and in-process control limits. Must be proficient in protein purification, including folding/refolding, chromatography, filtration, and process characterization. Expected to be knowledgeable in viral clearance, formulation, and product characterization. Team orientation is essential as well as the ability to coordinate efforts with Quality, Validation, Regulatory and other Research and Development groups in order to meet project timelines and company goals. Additional job expectations include ability to analyze and interpret analytical and process data and understand the process implications. Will be expected to identify new process technology methods and carry out the necessary experiments for implementation. Will be expected to effectively evaluate areas for process improvement and process optimization. Experience preparing and/or reviewing INDs, IMPDs, CTDs, BLAs or other regulatory discussion documents is essential, together with a good working knowledge of GMP and Quality issues. Must provide technical support to Clinical and/or Commercial Manufacturing. Excellent oral and written communication skills.

Position Requirements Minimum of 8 years of relevant industrial experience

Special Skills/Abilities: Prior supervisory experience is required. Excellent oral and written communication skills are essential. Prior GMP experience is a plus. Able to prepare/review CMC regulatory documents (IND, BLA). Able to review/approve Development Reports, as well as validation and tech transfer documentation, Batch Production Records, SOPs and other process documents. Familiar with computer software including word processing, data evaluation, statistical packages. Familiar with equipment at analytical and process scale. Demonstrated ability to manage complex projects.

Job Complexity: The job is highly complex, requiring a thorough understanding of the biological and chemical properties of recombinant proteins and monoclonal antibodies. Scientific and/or technical training in chromatography, separations technology and laboratory analytical techniques is required with prior Regulatory, GMP, and project management experience, if possible.

Supervision: Reports directly to an Associate Director but is expected to work independently on a day-to-day basis. Supervises a small team of Ph.D. and B.S./M..S. scientists and engineers.

Educational Requirements Requires a Ph.D. or equivalent in chemical/biochemical engineering, biochemistry, or chemistry.

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/