Job Description: Hybrid Role - approximately 50% onsite and 50% remote
Assignment is for routine business hours (i.e. 8am-4pm, 9am-5pm) Monday through Friday. Role is hybrid and will require both working from home and onsite work based on business needs. Non-routine work may include on-call and onsite presence during night and weekends up to 10%.
Job Summary:
Work independently to assist in investigation of process deviations, data trending, change controls and other documentation. Perform manual or automated process performance data extraction, reporting and analysis. Support in the execution of protocols including scheduling, communication, and coordination of sample delivery and data collection. Coordinate activities between Manufacturing Technology, Manufacturing operating groups, Supply Chain, and QA/QC to meet project timelines. Achieve high customer satisfaction through effective communication of both technical and non-technical topics with all levels of the organization both verbally and in writing.
Position Requirements:
Required BS degree in science or engineering related to biopharmaceutical process technology with minimum of 1-2 years biopharmaceutical industry experience.
Experience with electronic database systems and statistical analytical packages is highly desirable. Excellent verbal & written communications skills. Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization.
Broad knowledge of biopharmaceutical facility design and manufacturing operations is highly desirable. Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is desirable. Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas.
Additional Sills: