VP Development for Biologics Irvine CA

VP Development for Biologics

 
Job ID: Job-1967       
Job Title:      VP Development for Biologics   
location:       Irvine, CA     
Jobtype:        Permanent      
Rate:          
Primary Skills:        
Description:    Requirements 
Ph.D. in Bioengineering, Protein Chemistry, Biochemistry, Cell Biology, Microbiology or some combination thereof. 
15 or more years of experience in the development and manufacturing of biological products, including at least 10 years of management experience, is highly desirable. 
Understanding in the design and operation of fermentation/purification processing, technical sciences (e.g. bioanalytical), and cGMP bulk manufacturing operational requirements 
Experience working with CMOs 
Expert knowledge of cGLP and cGMP regulations and ICH guidelines pertaining to CMC biologics 
Experience with regulatory submissions and interactions with regulatory agencies 

Responsibilities 
Extensive experience working with CBER, CDER, and other divisions of the FDA, various Ministries of Health, and other international regulatory bodies is highly desirable. 
Experience executing timely and cost effective scale-up strategies for the manufacture of pre-clinical and clinical material under cGLP and cGMP, respectively. 
Experience working at a leading biopharmaceuticals innovator and will also have a strong biopharmaceutical background 

Email resume in Word to TheBigGameHunter@cisny.com. Please include the job code for the position with your resume. I will only respond to resumes that demonstrate a fit for the role. 

PAID RELOCATION. ONLY THOSE AUTHORIZED TO WORK IN THE US. VISA TRANSFERS ARE NOT AVAILABLE AT THIS TIME. NO 3RD PARTIES. NO OVERSEAS RESUMES, PLEASE. 
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