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Radnor, PA, US

2013 Janssen R&D Biologics Clinical Pharmacology April-September 2013(Job Number: 00000853)

Description

Centocor Research and Development, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is recruiting for a Biologics Clinical Pharmacology Co-op to be based Radnor, PA. The duration of this co-op is April to September 2013 (based on Drexel University's calendar).

Centocor develops innovative biomedicines. It is the world leader in monoclonal antibody production and technology and has brought critical biologic therapies to patients suffering from debilitating immune disorders.

Biologics Clinical Pharmacology Sciences at Centocor conducts nonclinical and clinical study sample bioanalysis to determine the concentration of Centocor drug products and anti-drug immune response in biological matrices. Scientists, develop and validate new assays and evaluate new technologies for immunoassay development. Once, the assay is transferred to the bioanalytical department, the assays are conducted and reports are written with interpretation of the data. These reports are added to submissions to Health Authority agencies for approval of our products. Centocor is a leader in mAb drug development with successful products and various new therapies in clinical trials.

Possible projects may include:

PROJECT 1 - (RC)

This lab-based a co-op position in the PK Assay Development and Validation group. The successful candidate will assist in development of generic antibody immunoassays to measure drug concentrations in human and animal blood samples using multiple platforms. Perform all tasks in accordance with the SOPs of the Biologics Clinical Pharmacology department. Record all experimental work in laboratory notebooks. Learn and perform routine laboratory tasks without supervision. Become proficient in handling, storage and use of human and/or animal blood samples. Receive training in assay development/validation for PK assays. In addition to the laboratory functions, the co-op is encouraged to take advantage of other learning opportunities such as attendance at scientific seminars or other presentations of interest

PROJECT 2 - (TM)

In this role you will conduct research in the Immune Response group. The individual will assess immune responses following the administration of therapeutic proteins with the label-free, real-time detection technology platform, Octet. This position requires designing and executing experiments to measure anti-drug antibodies with this new technology. The individual will have the challenge of increasing the sensitivity and throughput of this methodology and evaluating it against established platforms such as ELISA and Meso Scale Discovery immunoassays. The individual will collect and analyze data and prepare technical reports on the projects assigned. The incumbent will have the opportunity to learn the drug development process, acquire new laboratory skills and gain expertise with state of the art laboratory equipment.

PROJECT 3 - (DU)

In this role you will conduct research in the Bioanalytical group. The individual will conduct bioanalytical methods development and assay validation in support of new molecular entities (NMEs) entering drug development. The position involves development of methods to detect drug concentration in blood plasma/serum using state of the art technologies. The individual will record, store and summarize data and prepare technical reports on projects assigned. The incumbent will have the opportunity to learn about the entire drug development process. The individual will develop laboratory skills and familiarity with state of the art laboratory equipment. The position will be supervised, mentored and on the job training will be offered in support of quantification of therapeutic peptides and large molecules in biological matrices.

PROJECT 4 - (BW)

The candidate will perform laboratory assays using immunological and cellular biology techniques for the detection of neutralizing antibodies to protein therapeutics. Work will be performed in accordance with current GLP requirements. Job responsibilities include assay support, maintaining compliance with all appropriate SOPs for laboratory work, data recording and laboratory equipment. Additional responsibilities may include participation in routine lab operations (lab maintenance, safety inspections, etc.), SOP drafting, method and equipment validations, reagent qualifications, and/or other duties.

Qualifications


In order to be eligible for this position, you must be currently enrolled in an accredited college throughout the duration of the co-op (April - September 2013) and pursuing a Bachelor's degree in biological sciences, biochemistry, biotechnology or related scientific discipline with a minimum of 3.0 GPA. Some experience in laboratory techniques is required. Depending on the project, you might require experience performing immunoassays (ELISA, MSD, AlphaLISA), Mesco Scale Discovery, protein assays, or separation techniques. The company operates under strict FDA and GLP guidelines, therefore, excellent record keeping and the ability to maintain compliance with SOPs are essential. The candidate should be a self-starter, team worker. Computer proficiency in Microsoft Office Suite with knowledge of Excel and PowerPoint is required.

Student must be available from April - September 2013 and have the ability to work full-time during that time. Students must be able to provide their own transportation to/from their work location. Students must be legally authorized to work in the United States and not require future sponsorship for employment visa status (e.g. H1-B status) now or in the future.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Radnor
Organization: Janssen Research & Development, LLC. (6084)

Job: Administration