Monday, April 02, 2012

Keryx, Aeterna Tank as CA Drug Fails Trial - Apr. 2, 2012

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Events

2012 Workshop on Protein Aggregation and Immunogenicity
July 9-12, 2012
Early Registration: $695 - $1,395

Aggregation of therapeutic proteins can occur during bioprocessing, shipping, storage and even delivery to the patient. Understanding of the roles of aggregates in immunogenicity of therapeutic protein products is critical. Such immune responses can have serious consequences for patients. Also, immunogenicity can be major stumbling blocks to product development and has even plagued licensed protein therapeutics. To increase understanding of the impact of protein aggregation on immunogenicity, the Workshop will focus on five central areas:

1) clinical aspects of immunogenicity to therapeutic proteins;
2) utility of animal models and in vitro cell assays for assessing immunogenicity of aggregates and particles;
3) causes and control of aggregates and particles in formulations;
4) causes and control of aggregates and particles during processing; and
5) insights and challenges with analytical methods.

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Top Jobs
Biotech Bay (Santa Rosa, California)

On Assignment Clinical Research
Clinical Research Specialist
Works closely with the study manager to satisfy applicable clinical and regulatory requirements and internal requirements for clinical studies. This role focuses on assigned areas of clinical study management and provides support for clinical deliverables required in the Product Commercialization Process This role may perform some site training and co-monitoring.

Rocky Bio (Tucson, Arizona)

Ventana Medical Systems, Inc.
Clinical Data Specialist
Supervises data capture in clinical studies and implements tools to improve clinical data management, including quality initiatives to ensure that high quality clinical data sets are created to support US Food and Drug Administration (FDA) submissions for Ventana products.

Pharm Country (Bridgewater, New Jersey)

Omega Management Group
Clinical Quality Control Manager
Will manage the QC department in regards to clinical and regulatory documentation QC. In addition s/he will be responsible for the managing of the clinical departments SOPs in accordance with GCP guidelines. This includes training of responsible individuals within and across departments. In addition s/he will maintain and support QC audits of clinical Trial Master Files.

BioCapital (Rockville, Maryland)

Otsuka America Pharmaceutical, Inc.
Manager, Clinical Programming
Manages compound programming activities including the planning, coordination, and execution of the statistical programming functions in support of the clinical research project.

Biotech Beach (Irvine, California)

Allergan Inc.
Director, Clinical Development
Leads, directs and coordinates team activities (development and/or clinical) to ensure completion of the clinical development of projects of major importance to the corporation's long term future that are difficult and complex in nature and require the expert application of advanced knowledge in a broad area of science/technology.

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Biotech Beach

Biotech Beach Career Fair

Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Southern California area.

Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. (Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.)

Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research.

Job seekers may register here.

Biotech Beach Career Fair, La Jolla, CA April 17, 2012
BioCapital Career Fair, Bethesda, MD April 25, 2012
Pharm Country Career Fair, King Of Prussia, PA May 1, 2012
BioNC Career Fair, Durham, NC May 2, 2012
Biotech Bay Career Fair, Burlingame, CA May 29, 2012

More information about BioSpace's Career Fairs

BioSpace White Paper
Biotech Career Fairs For Job Seekers 101: Control Your Experience
By June Salvati, BioSpace Director of Events and Corporate Services
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