Head of Bioanalytical Alder Biopharmaceuticals

Alder Biopharmaceuticals is seeking an experienced, detail-oriented Scientist to lead, develop, perform and manage bioassay activities related to pre-clinical and clinical aspects of therapeutic monoclonal antibody drug development. This individual will be responsible for designing, developing, qualifying/validating and managing all bioassays related to pre-clinical, tox, GMP lot release of bulk and finished drug, clinical end point, immunogenicity, pharmacokinetics and pharmacodynamics. Principal duties include: hands-on development of cell-based, ELISA and Flow Cytometry-based bioassays, technology transfer of in-house developed methods to external vendors, providing oversight and managing all aspects of technical, scientific and GLP compliance quality-related issues.

Qualifications:
Requirements include a minimum of 5 years experience in bioassay development and execution in a similar position with a successful record of managing outside vendors to ensure regulatory compliance that support clinical activities. Experience in Mesoscale Device technology, ELISA methods and cell-based assay techniques necessary to support antibody drug development are required. Application of these techniques to pre-clinical (in-vivo/in-vitro), PK/TK and clinical assay activities is preferred. A detailed understanding of current GLP/GMP practices, safety and regulatory issues is a must. Experience hiring and managing scientific staff is required. This position requires excellent written and interpersonal communication skills as well as the ability to function in a fast-paced, team-oriented environment.

Location:	11804 North Creek Parkway South Bothell, WA 98011 United States