R&D Process Engineer
Provide ongoing scale-up, process development, and scientific support to the portfolio of the company products, client projects and upcoming projects across various industries.
·Lead and contribute to activities in the development of commercial converting, packaging and serialization processes for transdermal, dissolvable films and other drug products.
·Based on QbD principles, plan and execute process studies for feasibility, development/characterization (DOEs), capability, qualification and validation.
·Establish optimum process conditions for product quality, throughput and yield.
·Write specifications, protocols, SOPs, process development reports, etc.
·Ensure regulatory compliance throughout all development activities
·Maintain accurate and complete records of development activities
·Support operations with equipment specification, qualification/PM, commercial manufacturing activities, etc.
·Interface and provide leadership to project teams, vendors and clients in all activities from development to commercial scale production.
·Provide technical and/or scientific guidance to operations and internal teams when appropriate.
·Other duties as assigned
·Minimum of BS degree in science or engineering (mechanical/packaging) or related field, web-handling experience preferred.
·5 years of hands-on experience in manufacturing process development and scale-up within the pharmaceutical/medical device industry
·Knowledgeable and experienced with cGMP and the regulatory requirements for pharmaceuticals/medical devices preferred.
·Proven track record of planning and executing process development/scale-up projects, and an ability to meet aggressive timelines.
·Highly motivated individual who can work both independently and as part of a cross-functional team.
·Demonstrated problem-solving and analytical skills
·Strong technical writing and oral communication skills. Must be able to effectively communicate results or issues, verbally and in writing.
·Knowledge and experience with cGMP for pharmaceuticals/medical devices and QbD principles preferred.