The Scientist I 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 conducts and participates in 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 I 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. On-call support is required 1 in 10 days. The position may require limited travel (<10%).
Position Requirements :
Scientist I: 10-13 years with a B.S., 8-10 years with a M.S., or 0-3 with a PhD in physical sciences or engineering.
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.
Wide application of principles, theories, concepts and techniques in the area of validation.
Provides solutions to a wide range of difficult problems which requires creative thinking. Exercises significant technical discretion in design, execution, and interpretation, and pursues new experiments as a result of experimental outcomes.
Works under general supervision and has some latitude to determine and develop the approach to solutions. Frequently develops new methods, technologies, and processes when necessary for project advancement. Anticipates and resolves priority conflicts. Work is reviewed for soundness of technical approach.
Recommendations consistently result in project advancement. Conducts independent technology development or support programs. Has begun generating internal or external documents of value to the company. Has performed as a contributing member of one or more project teams.
Must demonstrate excellent communication skills, both verbal and written, and effective presentation skills. Contacts are frequent with individuals representing other departments, and/or representing outside organizations. Contacts involve obtaining or providing information or data on matters of moderate importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation.