Assistant Director: Immunoassay Group

Job Description: Midwest BioResearch, a WIL Research company, has an immediate opening at a senior level in the Immunoassay Group for an individual responsible for leading a group of scientists (M.S. and B.S. level) to develop, validate and implement bioanalytical assays for the support of biotherapeutics (including PK/TK, immunogenicity, cell-based neutralizing antibody assays). The successful candidate will have at least 5 years of hands-on experience in the development of these assays and managerial experience in pharmaceutics/biotechnology. The individual will have direct laboratory experience with development and troubleshooting of these assays as well as study director/principal investigator experience with GLP validation and analysis of study samples. Familiarity with FDA bioanalytical method validation guidance and industry guidances on immunogenicity method validation is required. Experience with protein modification reactions is also required. Prior CRO experience is a plus.

Responsibilities

• Manages workgroup involved in method development, validation, and implementation of bioanalytical assays for PK/TK and immunogenicity assessment (including cell-based assays) of biotherapeutics .
• Works with clients to plan and implement projects in bioanalysis.
• Reviews data for client studies and communicates directly with clients.
• Works with laboratory staff to monitor progress of studies and to troubleshoot problems in bioanalysis. Prepares technical reports, study protocols, and SOPs.
• Provides continuing education to laboratory staff in both basic principles and new techniques.
• Must be able to manage multiple priorities and with a sense of urgency.

Education/Requirements: Successful candidates will have a Ph.D. in immunology, biochemistry, or a related field. Previous industry (CRO, pharma, biotech) experience in these areas and GLP guidelines is desired. Candidates should also have excellent laboratory skills, project management skills, be detail oriented, and able to work as part of a team. Ability to communicate technical information verbally and in writing is essential.

If you are interested in becoming part of Midwest BioResearch's team, please email your resume and a cover letter to smorton@midwestbioresearch.com. No phone calls or recruiter inquiries.