Principal Engineer/Scientist - Process Development

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Cincinnati, OH
$120,000 - $145,000
Job Type
Direct Hire
Bachelor of Science
Sep 07, 2017
Job ID
The positions serves as the site’s Oral Solid Dosage (OSD) platform leader and reports directly to the Sr. Director of Process Development. Responsibilities include management and oversight of multiple early and late stage development projects and support personnel.

Job Functions:
Demonstrates technical expertise in OSD technology and methodologies.
Lead site related process development, scale-up, commercialization and tech transfer responsibilities Collaboratively develop project strategies to meet CMC objectives including design, write and oversee execution of development protocols to support project related activities. Conclude activities with appropriate technical reports to support regulatory submissions Provide leadership to a team of engineers, and technicians supporting Process Development and Clinical Manufacturing activities.
Communicate project status to department and site heads via written and oral communications.

Experience as a CMC or technical leader prioritizing and managing experimental strategies and communications to senior leadership.
Knowledgeable and proficiency in the design and manufacturing of OSD forms at development and commercial scales
Technical background in Formulation and Process Development of solid dosage forms, specifically; wet/dry granulation, direct compression (single and bilayer) and pan coating.
Knowledge in effective strategies to develop, scale-up and transfer complex R&D processes to Clinical and Commercial Manufacturing.
Working knowledge of Quality by Design and industry trends with Process Analytical Technologies Strong problem solving and analytical skills Working knowledge of statistics; classical, experimental al designs, and process controls Excellent verbal and written communication skills with experience communicating both up and down the organization. Strong technical report writing experience is required.
The desire to work in small, collaborative technical groups in a dynamic, fast-paced, work environment. PhD and 8+yrs, MS and 15+yrs, BS and 20+yrs experience in area of oral solid dosage pharmaceuticals industry with a degree in Engineering or a related field of study