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Senior Development Associate

Bayer Business and Technology Services LLC

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Location: Berkeley, CA Posted Date: 5/2/2013 Position Type: Full time Job Code: 58406 Required Education: High school or equivalent

Description

Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and
development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology,Oncology, Specialized Therapeutics, and Women's Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top
competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to e nsuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear. Bayer’s corporate culture is an important factor in the company’s success. Central to this culture are our values: Leadership, Integrity, Flexibility and Efficiency, summarized by the
term LIFE. They provide us with guidance for our daily work as we seek solutions to the major challenges of our time, in line with our mission statement “Bayer: Science For A Better Life.

Major Tasks:
•This position will hold a highly visible position within Global Biologics Development (GBD) – Analytical Development and Support Group (AD) as the Head of the Assay Support group within GBD-AD
•Be responsible for maintaining and supporting all the assays and testing for development projects from early development (pre-clinical) through late development (Phase III) release testing.
•Manage a group of 12 to 15 scientists and technicians currently supporting the testing of greater than 10,000 samples / year spanning ~ 40 different assays with a growing portfolio of biological products.
•Help improve / develop processes for the Assay Support group to better maintain appropriate turnaround times for critical testing and support of quickly developing projects within GBD.
•Develop / improve processes for sample handling, results review and reporting, and general laboratory practices.
•Will include SOP creation, as necessary and best business practice knowledge.
•Identifies compliance gaps, issues and opportunities of current processes
•Assist in headcount projections for project protfolio.
•Maintain working relationships within GBD, QA Development, QC Commercial and Regulatory Affairs as well as our Global Analytics Colleagues.

Requirements

Your qualifications Position Requirements:
•PhD. with a minimum of 12 years demonstrated relevant experience in the Analytical Testing
•Understand GxP requirements over entire development cycle
•Have a working knowledge of assay validation and regulatory requirements.
•Have excellent verbal and written communication skills including writing of scientific and technical reports and presentations
•Have the ability to interpret and effectively communicate scientific findings and recommendations in one-on-one discussions as well as departmental and functional meetings.
•Able to work in a fast-paced, changing environment with tight deadlines.
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