Assistant Manager, Technical Clinical Services - FDA, IND, NDA, PAI Phd, Ms, 3-5 yrs exp Inwood, NY (T00189D0) [11]

Assistant Manager, Technical Clinical Services

Assistant Manager, Technical Clinical Services - FDA, IND, NDA, PAI Phd, Ms,  
3-5 yrs exp Inwood, NY

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mailto:[EMAIL PROTECTED]:_T00189D0__Assistant_Manager,_Technical_Clinical
_Services

Assistant Manager, Technical Clinical Services  Research and Development
Inwood, NY
 
Description of Duties and Responsibilities:
·        Manage all clinical supplies activities that include scheduling, 
planning, review of protocols, master batch records and technical report 
summaries
·        Assume leadership role in managing direct reports in research 
activities relating to clinical manufacturing, scale-up and clinical supplies 
blinding as well as automation to increase production output
·        Evaluate performance of direct reports, training and development of 
staff members
·        Present scientific studies to peers and management along with 
participation in outside professional organization
·        Interface with Clinical Packaging group to develop timeline and 
numbers of units required
 
Requirements:
§         Bachelor of Science with 6-10 years, Master of Science with 5-8 years 
or Ph.D. with 2-3 years of experience in the pharmaceutical industry or 
chemistry 
§         Candidate must have an understanding of FDA requirements in IND, NDA, 
PAI and SUPAC guidance
§         Ideal candidate should have good knowledge of drug product 
manufacturing unit operations and control
§         Candidate should also have managerial, interpersonal and good 
leadership skills
§         Excellent verbal and written communications required

Opensoft Inc.
332 King St. W, Suite 201
Toronto, ON  M5V 1J2
E-mail: [EMAIL PROTECTED]