Sr Scientist


Job ID 17-00255

Industry Pharma

Job Type Permanent

Location Denville, NJ

Description

Job Description Summary:
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 of Generic Topical Formulations. 
Full Details:
•    Independently create and implement experiments for formulation development of Topical products (ointments, creams, gels, lotions) 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 for scale up & clinical batches and provide technical assessments 
•    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.
•    SOPs, change controls, deviations and CAPAs.
•    Lead and provide responses times for information requests and complete responses from FDA on submitted projects. 
•    Provide updates timely to the upper management



Qualifications

Requirements:
•    Masters or associated equal degree in pharmaceutics or chemistry or chemical engineering or relevant life sciences
•    At least 5 years of experience in Topical ANDA products
•    Experience in handling the lab process equipment: mixers and homogenizes, Viscometers , in vitro drug release and in vitro flux studies (membrane and skin)
•    Knowledge on the CMC sections , FDA and ICH regulations
•    Must have excellent communication skills, organizational ability and good documentation capabilities