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Job (this posting is now closed/inactive)


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General Information

(3637532)

Job title: Process Engineer - Derma Development
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Job location: Durham, NC  27703 United States
Requisition code:
Date posted: 07/21/2017
Compensation: Competitive Package
Job category:Research and Development
Employment type:Full time
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Job Description


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Local candidates only – will not cover relocation

Must be legally able to work in the USA without requiring sponsorship.

JOB SUMMARY

· Independently works with formulation group to develop and optimize Topical Dosage Forms manufacturing processes.

· Independently designs and performs experiments (As per QbD concept) in the development of processing unit operations for Topical Dosage Forms.

· Basic knowledge of Viscodynamic properties and Rheology.

· Must have knowledge of Topical Dosage Form (semisolid and liquid) manufacturing process and Creative problem-solving skills in administration of operational challenges during product manufacturing and following Technical Transfer.

· Oversees and coordinates the manufacturing events during product development.

· Writes and executes development protocols for all processing unit operations of Topical Dosage Forms Manufacturing.

· Candidate must be well versed with statistical tools and handle the statistical data related to QbD analysis and coordinating with manufacturing units in relation to data collected during process scale up batches.

· Maintains current and accurate documentation for raw materials and process specifications such as Standard Operating Procedures (SOP), Material Specifications (MS), Master Production Formula (MPF), etc.

· Prepares assigned sections of ANDA and NDA FDA submissions. Assist with responding to FDA questions related to submissions.

· Interfaces with other departments and outside vendors to source, procure and write specifications for raw materials and final products.

· Conducts presentations of data and findings to management as required.

· Performs related duties as assigned.
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Job Requirements


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REQUIRED:

BS with 6 + Years’ Experience or MS with 4+ Years’ Experience with Relevant degree (BS/MS) in a Scientific / Engineering Discipline.

PREFERRED:

Proven industry experience in the Pharmaceutical Industry is essential.
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