ASSOCIATE DIRECTOR - PK Method Validation & Bioanalysis Automation

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The J&J Biotechnology Center of Excellence, part of Centocor R&D, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director of PK Method Validation / Bioanalysis Automation, Biologics Clinical Pharmacology, located in Radnor, PA.

The J&J Biotechnology Center of Excellence group supports development of innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.

This is a technical management position within the PK Assay Development, Validation and Bioanalysis group in the Biologics Clinical Pharmacology Department. This group is responsible for developing and validating immunoassay methods used for bioanalysis of large molecule biotherapeutic drug candidates (NMEs) across all therapeutic areas of J&J beginning with nonclinical toxicology studies to post-market clinical development. The incumbent will work closely with senior staff and peer staff in Biologics Clinical Pharmacology, Biopharmaceutical Research, various Clinical Teams and Compound Development Teams and with cross-company peers to identify appropriate strategies for the development and validation of analytical methods using robotic automation in support of clinical and nonclinical development studies. The incumbent is also responsible for documentation of method development in internal reports and in documents for submission to worldwide health authorities.

The incumbent should have extensive experience in the development and validation of analytical immunoassay methods using robotic automation and possess a thorough understanding of applicable regulatory requirements for method validation. All work will be performed within a GLP environment. Additionally, it is expected that new immunoassay and automation technologies and other analytical methodologies will be evaluated and implemented as appropriate into the group activities.

The incumbent will also be responsible for representation of Biologics Clinical Pharmacology on various clinical or compound development teams, as well as departmental internal and cross-departmental teams.

The successful candidate should will have a minmum of a Bachelors degree in a related scientific discipline with at least 10 years or a PhD and 5 years of industry experience. Individual must have extensive experience in all aspects of immunoassay development and validation and in robotic assay automation in a regulated laboratory environment. Experience in orthogonal technologies for large molecules such as LC, LC/MS, SPR, affinity chromatography, protein conjugations and electrophoresis development experience is a plus. Demonstrated ability to propose and design experiments, troubleshoot issues with assay performance, and effectively present results and conclusions is required. Candidates should have excellent record keeping and oral and written communication skills and be able to work in a GLP environment.

As a valued team member, you’ll receive a competitive salary and great benefits including medical/dental, a 401(k), a pension plan and a comprehensive wellness program. If interested, please apply directly on-line at our web site www.careers.jnj.com noting Req. Code. The Johnson & Johnson Family of Companies has a strong commitment to diversity and welcomes applications for all individuals. EOE M/F/D/V