Scientist, AS&T
Randstad USA · Norwood, MA · 3 wk ago
On-siteAnalyst$65–$90/hrContract
About the role
Advance your career in the premier biotech hub of Norwood, MA! Randstad Life Sciences is seeking a Scientist, AS&T for a 6-month extendable contract position with a top-tier global biopharmaceutical leader. In this technical leadership role, you will oversee analytical method lifecycle management, method validation, transfers, regulatory submissions, and complex technical investigations for late-stage and commercial biopharmaceutical products. Location: Norwood, Massachusetts. Job type: Contract (6‑month, extendable). Work hours: 9 to 5.
Responsibilities
- Lead analytical method lifecycle activities including validation, transfer, optimization, remediation, and continued verification within a cGMP environment.
- Author and own validation protocols, transfer protocols, SOPs, and technical reports adhering to ICH Q2(R2) and global regulatory standards.
- Provide technical leadership for complex analytical investigations, root cause analyses, and method troubleshooting.
- Author and review regulatory submission documents (Module 3) and draft responses to Regulatory Authority Questions (RTQs).
- Partner cross-functionally with Analytical Development, Quality Control, and global contract testing laboratories.
Requirements
- Ph.D. with 0‑3 years, Master's with 5+ years, or Bachelor's with 7+ years of experience in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline.
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