AS&T
Biotechnology
AS&TPrincipalScientistCGT&Biologics
“AS&T Principal Scientist - CGT & Biologics at AS&T. Skills: CGT, Biologics, Analytical CMC. Support preparation of regulatory submission sections. Author technical documents”
Industry & Context.
Data verification; Statistical analysis
What They're Looking For.
Must Have
M.S. or equivalent degree and 6+ years experience, B.S. or equivalent degree and 9+ years experience, Proficiency in statistical analysis tools
Nice to Have
Regulatory writing experience highly desirable, Prior experience with CTOs or CDMOs is a plus, Familiarity with commercial program lifecycle preferred, Familiarity with QMS systems preferred, Familiarity with regulatory submission expectations preferred
What You'll Do.
Support preparation of regulatory submission sections
Author technical documents
Review technical documents
Assist with QMS activities
Perform data verification
Perform statistical analysis
Collaborate cross-functionally
How You'll Work.
Team & Collaboration
Internal stakeholders; External partners
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