Sr. Director, Biologics Contract Manufacturing - San Diego

This position is open as of 5/9/2008. Are you a fit? Click Here to Apply Now! Job Details Sr. Director, Biologics Contract Manufacturing - San Diego renderImage('http://www.cybercoders.com/images/search.png', 84, 39); Specifications Location   San Diego, CA; Irvine, CA Salary   $140,000 - $160,000 Education   Masters of Science Category   Pharmaceutical Experience Required   At least 2 Years Short Description   Sr. Director, Biologics Contract Manufacturing - San Diego Required Skills   Biologics, GMP Manufacturing, Technology Transfer, CMO Contract Manufacturing, CMC Regulatory Recruiter   David Wright Date Updated   5/9/2008 Job Description Skills Required Biologics, GMP Manufacturing, Technology Transfer, CMO Contract Manufacturing, CMC Regulatory Job Description Sr. Director, Biologics Contract Manufacturing - San DiegoWe are a biotechnology company focused on developing treatments for major neurodegenerative disorders using a proprietary gene delivery technology. We brought gene therapy products for Alzheimer's disease and Parkinson's disease through pre-clinical development and into clinical trials and also have research programs investigating therapies for other neurodegenerative disordersResponsibilities:* Oversee all aspects of manufacturing processes. * Participate in planning the overall manufacturing strategy for product development for drugs and delivery devices, ensuring alignment with overall business strategy. * Manage a team of five manufacturing and process development professionals in the planning and execution of manufacturing for advanced clinical trials. * Manage the selection, contract, coordination with and performance of external CMO's. * Plan and direct the technology transfer of products from research and development to international or domestic CMO's including process limits studies and process validation studies. * Participate in regulatory strategy and planning, managing the CMC regulatory submission process.Requirements:* Degree (prefer Master's or Ph.D.) in a biological, chemical or biotechnology engineering or related discipline * 8+ years management experience in a cGMP pharmaceutical manufacturing environment with small and large scale cell culture, fermentation and/or purification for biologics products. * Must have regulatory knowledge and experience dealing with regulatory agencies (FDA). * Must have experience with CMO selection, contract negotiation, and management. * Good leadership and people management skills, sound judgment, exceptional organizational and project management skills, and ability to multi-task and thrive in a fast-paced entrepreneurial environment. Location: San Diego, California; Irvine, California Want to interview today? Click Here to Do a Quick 2-Minute Online Interview! Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: Email your resume in Word to: David.Wright@CyberScientific.com **Please do NOT change the email subject line in any way. You must keep the JobID: CC MonsterAp : DW-CA-DMFG1 -- in the email subject line for your application to be considered.*** David Wright - Senior Recruiter - CyberScientific   logET();PauseFooter(false);