Job Description

PRINCIPAL ENGINEER – DEVICE DELIVERY

The Principal Engineer leads a Cross functional Team, directs the design, development and implementation of primary drug containers and new Device Delivery Technologies. The Principal Engineer will be responsible for component selection, assessment of container-device compatibility and container-drug compatibility, development of testing methods to assess container and delivery system quality and functionality for existing and new technologies. This Principal Engineer also leads the assessment, selection and implementation of new drug product configurations in collaboration with engineers and scientists in the department. The Engineer provides guidance and input to project core teams and sub-teams in the area of primary containers and combination product development. The Principal Engineer regularly interfaces with staff and leaders in Contract Manufacturing, Project Core Teams, Development, Early and Late Stage Pharmaceutical Development, Quality and Regulatory Affairs, and regularly interacts with external development partners and component suppliers. The Principal Engineer also supervises 2-3 staff.

Requirements:

• Advanced degree, B.S., M.S., or Ph.D, in Mechanical Engineering or the equivalent.

• More than 14 years of experience in industry or academia (including advanced studies) after receiving their Bachelors Degree.

• Excellent leadership skills to lead Team, or cross functional Team, to ensure success of the project.

• Experience in DOE, problem solving, model using physical rules.

• The candidate must have expertise in six sigma (such as DMAIC, DFFS), as a green or black belt, and also must have a good understanding of statistics.

• A working knowledge of manufacturing, quality control, preclinical and clinical development, and regulatory issues pertaining to combination products is preferred. A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is very desirable.

• Excellent communication skills are required.

• Experience in working with external partners is also highly desirable.

To apply for this position, send a copy of your resume in word or pdf format to info@branfordsearch.com