Scientist II, Pharma QC Validation, Transfer and Registration (VTR)

Scientist II within Pharma Validation, Transfer and Registration (VTR) provides subject matter expertise in analytical method validation, transfer, investigations, and regulatory filings for small molecule and antisense oligonucleotide (ASO) products. You will lead cross-functional validation and technology transfer activities across internal QC laboratories and external contract labs, author and review analytical procedures and regulatory submission documents, perform statistical analysis, troubleshoot complex analytical investigations, and ensure methods meet global regulatory requirements. This role requires driving technical oversight of contract laboratories, coordinating cross-site projects, and collaborating with QC, Analytical Development, Manufacturing Science, Regulatory Affairs, and Quality Assurance to support late-stage development and commercial programs. A strong background in GMP, analytical instrumentation (LC/MS, UHPLC, GC, Karl Fischer, dissolution), and global regulatory expectations (ICH, USP, EP, JP, ChP) is required, with travel up to 30% domestically and internationally. The position reports to the Director of VTR and involves mentoring junior scientists and providing strategic input for lifecycle management of Biogen’s portfolio.