The Scientist II core responsibilities include designing validation sampling/test plans, performing development studies, generating validation protocols, executing validation studies, resolving technical issues encountered during study execution, and preparing validation final reports. This position independently plans, designs, and executes projects that are complex and scientifically demanding. This position has involvement in all core areas of biopharmaceutical validation: cleaning, sterilization, process, manufacturing/analytical equipment, and utility system qualifications. The individual is expected to work independently or in collaboration with others. Projects are assigned by management. Excellent written skills is essential.
The Scientist II also supports technology transfer activities tracked in the site change control system, method validation/method transfer, filter validation, shipping qualification, and FAT/SAT/Commissioning activities. The individual may assist with validation master plans. The individual is expected to possess strong technical skills and experience with biopharmaceutical unit operations and equipment.
The individual may also be responsible for developing project plans and coordinating and reviewing work performed by contract staff.
The position may require off-shift and weekend work. The position may require limited travel (<10%).
Position Requirements :
Scientist II: 13-15 years with a B.S., 10-13 years with a M.S., PhD.
Experience in a cGMP biopharmaceutical production setting with a focus in large scale mammalian cell culture processes and process development is required. Working knowledge of industry standards, safety, quality, and regulatory concepts including the application of current cGMPs is required.
B.S. or M.S. in Engineering, Biological/Physical Sciences, or equivalent focus of study.
Knowledge: Applies extensive expertise in the area of validation. Has a working knowledge of related disciplines. Maintains a high level of expertise through review of scientific literature, submissions to journals, and attendance and participation at scientific conferences.
Develops solutions to complex problems requiring ingenuity and creativity. Exercises significant technical discretion in design, execution, and interpretation, and pursues new experiments as a result of experimental outcomes.
Work is performed without appreciable direction. Has latitude in determining scientific objectives of assignment. Work is monitored for scientific judgment and achievement.
Decisions or recommendations consistently result in achieving one or more key project objectives. Internal recognition as an emerging expert through objective criteria such as publications, internal presentations, and critical contributions to technology development. Has begun demonstrating leadership through project team participation, internal consulting and mentoring. Influences scientific thinking and direction on projects.
Must demonstrate excellent communication skills, both verbal and written, and effective presentation skills. Establishes contacts with outside centers of excellence and has contact with customers and suppliers. Has some external alliances. Active in professional organizations. Effectively communicates scientific thought and logic in oral and written presentations.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation.