Director – Bioanalytical Operations

Description: The principal responsibilities of this position are to provide strategic and managerial oversight of all bioanalytical operations including overseeing bioanalytical method development, validation, and sample analysis in support of peptides, hormones and proteins (biomarker, cell-based, PK, immunogenicity, immuno-, and enzymatic assays), bioanalytical project management, and bioanalytical material/instrument management. The position requires managing bioanalytical operations departments (up to 30 people) through a team of functional managers and front line supervisors. The employee will direct, develop, and provide technical mentoring to staff to establish operational procedures, solve scientific problems, and develop technical protocols. The employee will work with senior management on the planning and development of operational policies, objectives and initiatives.

A major focus of the Director of Bioanalytical Operations is to align objectives and resources across all bioanalytical teams and projects, in particular assuring that resources allocated to a given functional group match the workload priorities. In this context, close control and use of the bioanalytical internal resources to meet client’s expectations/timelines is essential. The employee will help with the preparation and presentation of proposals to the clients. In addition, this position will monitor the production of regulatory documents generated within Bioanalytical Operations, in collaboration with Quality and the Data Management teams. The Director of Bioanalytical Operations is expected to supervise and mentor the junior staff and develop a career ladder for each employee. The employee will maintain contact with the Sales and Marketing team in order to achieve project objectives and establish realistic timelines. The employee may be required to travel to meet with clients as needed.  In some instances, the Director of Bioanalytical Operations may also fulfill the role of Bioanalytical Project Manager.

Requirements: Requires Masters degree or Ph.D. in molecular biology, biochemistry, immunology or related field with 15+ years broad bioanalytical experience in pharmaceutical/biotechnology/CRO preclinical and clinical assay development/bioanalytical operations, or some exceptional candidates with Bachelor’s degree, 20+ years broad bioanalytical experience pharmaceutical/biotechnology/CRO preclinical and clinical assay development/bioanalytical operations and reputation as industry leader. Working knowledge of various immunoassay platforms including ELISA and MSD-ECL is a must.  Experience in leading cross functional teams, bioanalytical operations, and product/project management in the pharmaceutical/biotechnology industry. In-depth understanding of GLP and/or GMP procedures.  Must have working knowledge of the FDA and EMEA guidelines and industry standards. Ability to work in a fast paced environment where multiple projects are in process and must be completed in a timely manner.  Excellent oral and written communication skills are essential.  Demands during peak times may require work hours outside of normal working hours.  Business travel is a component of the position.

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