Senior Formulation Scientist in Elizabeth, NJ

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Matthew Masterson
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Senior Formulation Scientist in Elizabeth, NJ

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Responsible for independently creating and implementing formulation development strategies. 
Design, direct and/or conduct pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing on assigned projects.
• Independently create and implement strategies for formulation development and solves complex problems. 
• Review and authorize reports/documents such as product development reports, quality overall summary, master formulas and other key reports/ documents. 
• Coordinate with contract research organizations and provides technical assessments on alternative drug delivery technologies. 
• Conduct briefings and technical meetings for top management and representatives. 
• Act as lead role after the Head of Formulation Development. 
• Provide technical and administrative leadership to a significant group of scientific professionals; Manage the progress of the projects in the team. 
• Represent Formulation Development and acts as subject matter expert with government agencies, e.g. FDA during PAI or in responding to deficiencies to submitted ANDA applications. 
• Set annual performance goals and conducts semi-annual and annual performance evaluations for reporting staff; Provide input for annual department budget; and Act as area management for SOPs, change controls, deviations and CAPAs. Education Applicants must have a Master's Degree (or foreign equivalent) in Pharma Sci, Chemistry or related field, plus seven years of experience in formulation development, process development and/or manufacturing. 
Applicant must have solid understanding of pharmaceutical dosage forms including controlled release drug delivery technologies, with Modified Release Dosage Forms- Matrix Tablets & Multiparticulate Dosage Forms, thorough knowledge of Good Manufacturing Practices, and knowledge of FDA regulatory guidance's, ICH guidelines and requirements of ANDA submissions. EOE Statement 
EOE Statement EOE Minorities/Females/Protected Veterans/Disabled 
Equal Opportunity is the Law poster: English